Initial Notices for Parallel Distribution – 2007 · European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London,

European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51

E-mail: [email protected] http://www.emea.europa.eu © European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged.

London, 26 June 2008 Doc. Ref. EMEA/311899/2008

Initial Notices for Parallel Distribution – 2007

Parallel distributor

Date of

notification Product name Strength Pharmaceutical

dosage form Pack size

Member State(s) of Origin

Member State(s) of

Destination

Date of EMEA Notice

Autumn Healthcare Ltd

12-Mar-07 Abilify 10mg Orodispersible tablets

28x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/ES/SE/UK

UK/IE 8-Aug-07

AxiCorp Pharma 07-Sep-06 Abilify 10mg Tablets 98x1 AT/BE/DK/FI/FR/GR/IE/IT/LU/NO/NL/PT/ES/SE/

DE 1-Feb-07

B&S Healthcare 19-Jul-07 Abilify 10mg Orodispersible tablets

28x1 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 1-Oct-07

Chemilines Ltd 13-Aug-07 Abilify 10mg Orodispersible tablets

28x1 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/ MT/NL/NO/PL/PT/ES/SE

UK/IE 14-Sep-07

Colorama 17-Jan-07 Abilify 10mg Orodispersible tablets

28x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 11-Sep-07

Colorama 06-Mar-06 Abilify 10mg Tablets 28x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 10-Sep-07

Cross Pharma AB 24-Nov-05 Abilify 10mg Tablets 28x1 IT/ES SE 2-Mar-07

Docpharm 05-Sep-07 Abilify 10mg Tablets 14x1 AT/BE/DK/FI/FR/GR/IE/ IT/LU/MT/NL/NO/PT/ES/UK

DE 19-Nov-07


DE 19-Nov-07

EMEA/311899/2008 © EMEA 2008 Page 2/153


DE 19-Nov-07

GenPlus Ltd 24-Oct-07 Abilify 10mg Tablets 28x1 AT/BE/CZ/DK/FI/FR/DE/ GR/IE/IT/LU/MT/NL/PT/ ES/SE

UK 5-Nov-07

Intercare 07-Mar-05 Abilify 10mg Tablets 28x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE/

UK/IE 9-Mar-07

Intercare 14-Mar-07 Abilify 10mg Orodispersible tablets

28x1 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 12-Sep-07

Kohlpharma 4-Dec-06 Abilify 10mg Orodispersible tablets

49x1 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 2-Apr-07

Mediport 30-Mar-07 Abilify 10mg Tablets 28x1 AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 30-Apr-07

N.G. Ltd 03-May-05 Abilify 10mg Tablets 28x1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 7-Nov-07

Orifarm A/S 28-Nov-05 Abilify 10mg Tablets 28x1 FR/ES/UK DK 16-Feb-07


Orifarm A/S 28-Nov-05 Abilify 10mg Tablets 14x1 FR/ES/UK/IT DK 16-Feb-07

Orifarm AB 30-Apr-07 Abilify 10mg Orodispersible tablets

28x1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 6-Jun-07

Orifarm OY 18-Dec-06 Abilify 10mg Tablets 56x1 AT/BE/CY/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

FI 14-Feb-07


FI 14-Feb-07

Paranova AB 27-Mar-06 Abilify 10mg Tablets 14 AT/FR/IT/ES SE 5-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 3/153


Paranova AS 21-May-07 Abilify 10mg Tablets 28x1 AT/BE/FI/FR/DE/GR/IT/ NO/PT/ES/SE/UK

DK 11-Jun-07

Paranova AS 30-May-07 Abilify 10mg Tablets 56 AT/BE/FI/FR/DE/GR/IT/ NO/PT/ES/SE/UK

DK 28-Jun-07

PCO Ltd 31-Aug-07 Abilify 10mg Tablets 28x1 AT/BE/CY/DK/FI/FR/DE/GR/IT/LU/MT/NL/PT/ ES/SE/UK

UK/IE 30-Nov-07

Pharma Westen 28-Feb-07 Abilify 10mg Orodispersible tablets

49 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/ SE/UK

DE 2-Jul-07

Pharma Westen 13-Dec-05 Abilify 10mg Tablets 14x1 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LI/LU/NL/NO/PT/ ES/SE/UK

DE 2-Jul-07


DE 2-Jul-07


DE 2-Jul-07

Pharmachim AB 25-Oct-07 Abilify 10mg Tablets 56x1 AT/BE/CY/FR/DE/GR/IT/NL/PT/ES/UK

SE 30-Nov-07

Prospect Pharmaceuticals

07-Aug-06 Abilify 10mg Tablets 28x1 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 26-Mar-07

SinGad Pharma ApS

05-Sep-06 Abilify 10mg Tablets 56x1 ES DK 13-Feb-07

SRL Pharmaceuticals

25-Oct-05 Abilify 10mg Tablets 28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK 10-Jan-07


12-Mar-07 Abilify 15mg Orodispersible tablets

28x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/ES/SE/UK

UK/IE 8-Aug-07

AxiCorp Pharma 28-Apr-06 Abilify 15mg Tablets 98x1 AT/BE/DK/FI/FR/GR/IE/IT/LU/NO/NL/PT/ES/SE/

DE 1-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 4/153

B&S Healthcare 19-Jul-07 Abilify 15mg Orodispersible tablets

28x1 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 1-Oct-07

Chemilines Ltd 13-Aug-07 Abilify 15mg Orodispersible tablets

28x1 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PL/PT/ES/SE

UK/IE 14-Sep-07

Colorama 17-Jan-07 Abilify 15mg Orodispersible tablets

28x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 11-Sep-07

Colorama 06-Mar-06 Abilify 15mg Tablets 28x1 AT/BE/DK/FIN/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 10-Sep-07

Cross Pharma AB 24-Nov-05 Abilify 15mg Tablets 28x1 IT/ES SE 2-Mar-07

Emra-Med 25-May-07 Abilify 15mg Orodispersible tablets

49x1 AT DE 20-Aug-07

G-Pharma 20-Jun-06 Abilify 15mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 19-Jan-07

G-Pharma 09-Feb-07 Abilify 15mg Tablets 14x1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 16-Mar-07

Intercare 07-Mar-05 Abilify 15mg Tablets 28x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK/IE 9-Mar-07

Intercare 14-Mar-07 Abilify 15mg Orodispersible tablets

28x1 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 12-Sep-07

Kohlpharma 16-Jan-07 Abilify 15mg Orodispersible tablets

49x1 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 2-Apr-07

Lexon 06-Jul-07 Abilify 15mg Orodispersible tablets

28x1 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/ PT/NO/PT/ES/SE

UK 24-Oct-07


UK 30-Apr-07


UK 7-Nov-07

EMEA/311899/2008 © EMEA 2008 Page 5/153


Orifarm A/S 28-Nov-05 Abilify 15mg Tablets 28x1 FR/ES/UK/IT DK 16-Feb-07

Orifarm AB 30-Apr-07 Abilify 15mg Orodispersible tablets

28x1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 6-Jun-07


FI 14-Feb-07


FI 14-Feb-07




UK/IE 30-Nov-07

Pharma Westen 28-Feb-07 Abilify 15mg Orodispersible tablets

49 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/ UK

DE 2-Jul-07


DE 2-Jul-07


DE 2-Jul-07


DE 2-Jul-07

Pharmachim AB 25-Oct-07 Abilify 15mg Tablets 56x1 AT/BE/CY/FR/DE/GR/IT/NL/PT/ES/UK

SE 30-Nov-07

SinGad Pharma ApS

05-Sep-06 Abilify 15mg Tablets 56x1 ES DK 13-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 6/153

SRL Pharmaceuticals


UK 10-Jan-07

Veron Pharma 01-Dec-06 Abilify 15mg Tablets 14x1 AT/BE/FR/GR/IT/NL/PT/ ES

DE 26-Jul-07


DE 26-Jul-07


DE 26-Jul-07

Swingward Ltd T/A Medihealth

16-Oct-07 Abilify 1mg/ml Oral solution 150 ml AT/BE/CY/CZ/DK/EE/FI/GR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PO/PT/SK/SI/ES/SE

UK 9-Nov-07


UK 10-Sep-07

G-Pharma 12-Feb-07 Abilify 30mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 24-Apr-07

Intercare 13-Feb-07 Abilify 30mg Tablets 28x1 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 14-Aug-07

O.P.D. Laboratories Ltd.

08-Nov-06 Abilify 30mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 8-Aug-07

Orifarm AB 30-Apr-07 Abilify 30mg Tablets 56X1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 6-Jun-07


UK/IE 30-Nov-07

Pharma Westen 10-Sep-07 Abilify 30mg Tablets 49x1 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 25-Sep-07

SRL Pharmaceuticals


UK 10-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 7/153


10-May-07 Abilify 30mg Tablets 28x1 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 28-Jun-07



UK 12-Feb-07


UK 10-Sep-07

Docpharm 24-Aug-07 Abilify 5mg Tablets 49x1 AT/BE/DK/FI/FR/GR/IE/ IT/LU/MT/NL/NO/PT/ES/UK

DE 19-Nov-07

G-Pharma 31-Oct-06 Abilify 5mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/LI/LU/MT/NL/NO/ PT/ES/SE

UK 10-Jan-07

Intercare 07-Mar-05 Abilify 5mg Tablets 28x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK/IE 9-Mar-07


UK 30-Apr-07


UK 7-Nov-07

Orifarm AB 30-Apr-07 Abilify 5mg Tablets 14x1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 6-Jun-07


SE 6-Jun-07


SE 6-Jun-07

Orifarm OY 30-Apr-07 Abilify 5mg Tablets 28x1 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/UK

FI 6-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 8/153

Orifarm OY 30-Apr-07 Abilify 5mg Tablets 56x1 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/UK

FI 6-Jun-07

Paranova AS 05-Jul-07 Abilify 5mg Tablets 56x1 FI/IT/NO/ES/SE/UK DK 3-Dec-07

Paranova AS 29-Nov-07 Abilify 5mg Tablets 28x1 AT/BE/FI/FR/DE/GR/IE/ IT/NL/NO/PT/ES/SE/UK

DK 13-Dec-07


UK/IE 30-Nov-07

Pharma Westen 16-Jun-06 Abilify 5mg Tablets 49x1 AT/BE/CY/CZ/DK/EE/FI/FR/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SK/SI/ES/SE/UK

DE 1-Mar-07



UK 12-Feb-07

SRL Pharmaceuticals


UK 10-Jan-07


06-Nov-06 Abilify 5mg Tablets 28 AT/BE/CY/CZ/DK/EE/FI/FR/GR/DE/HU/IT/IE/IS/LI/LU/LT/LV/MT/NL/ NO/PL/PT/SI/SK/ES/SE

UK 11-Jun-07


27-Sep-06 Acomplia 20mg Film-coated tablets

28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE/UK

UK/IE 14-Feb-07




UK/IE 14-Feb-07




UK/IE 14-Feb-07

Beta Kbix Ltd 19-Oct-06 Acomplia 20mg Film-coated tablets

28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 3-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 9/153



UK 3-Jan-07



UK 3-Jan-07



UK 3-Jan-07

Beta Pharmaceuticals

27-Oct-06 Acomplia 20mg Film-coated tablets


UK 12-Feb-07




UK 12-Feb-07




UK 12-Feb-07

BR Pharma 05-Sep-06 Acomplia 20mg Film-coated tablets

28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IT/LI/LU/MT/NL/ NO/PT/ES/SE

UK/IE 5-Jan-07

Chemilines Ltd 11-Oct-06 Acomplia 20mg Film-coated tablets

28 AT/BE/CY/DK/FI/FR/GR/DE/IT/IE/IS/LI/LU/MT/NL/NO/PT/ES/SE

UK 4-Jan-07



UK 4-Jan-07



UK 4-Jan-07

Colorama 27-Nov-06 Acomplia 20mg Film-coated tablets

28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 9-Mar-07



UK 9-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 10/153



UK 9-Mar-07

Cross Pharma AB 25-Apr-07 Acomplia 20mg Film-coated tablets

98 FI/FR/DE/GR/IT/NL/PT/ES/UK

SE 25-Jun-07

Cross Pharma AB 25-Apr-07 Acomplia 20mg Film-coated tablets

28 FI/FR/DE/GR/IT/NL/PT/ES/UK

SE 25-Jun-07

Ginova 14-Dec-06 Acomplia 20mg Film-coated tablets

28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 7-Feb-07

Global Farma BV 31-Jul-07 Acomplia 20mg Film-coated tablets

28 BE/FR/GR/IT/PT/UK NL 28-Sep-07

G-Pharma 24-Nov-06 Acomplia 20mg Film-coated tablets

28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 29-Jan-07



UK 29-Jan-07



UK 29-Jan-07

Intercare 27-Oct-06 Acomplia 20mg Film-coated tablets

28 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 12-Feb-07

Interport 18-Oct-06 Acomplia 20mg Film-coated tablets

28 AT/DE/PT UK 4-Jan-07

Kohlpharma 31-Aug-07 Acomplia 20mg Film-coated tablets

28 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 24-Oct-07

Lexon 23-Jan-07 Acomplia 20mg Film-coated tablets


UK 4-Sep-07

N.G. Ltd 06-Oct-06 Acomplia 20mg Film-coated tablets


UK 6-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 11/153



UK 6-Feb-07



UK 6-Feb-07

Oakleigh Pharmacy 03-Oct-06 Acomplia 20mg Film-coated tablets

28 DE UK 10-Jan-07


56 DE UK 10-Jan-07


98 DE UK 10-Jan-07

Orifarm AS 22-Dec-06 Acomplia 20mg Film-coated tablets

28 AT/BE/CY/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

DK 26-Apr-07

Orifarm AS 22-Dec-06 Acomplia 20mg Film-coated tablets


DK 26-Apr-07

Paranova A/S 15-Jan-07 Acomplia 20mg Film-coated tablets

28 DE/FI/NO/SE/UK DK 23-Mar-07

Pharma Westen 14-May-07 Acomplia 20mg Film-coated tablets

28 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 19-Jul-07



DE 19-Jul-07



DE 19-Jul-07

SRL Pharmaceuticals

16-Nov-06 Acomplia 20mg Film-coated tablets


UK 14-Mar-07

Stephar (UK) Ltd 22-Dec-06 Acomplia 20mg Film-coated tablets

28 AT/BE/FR/DE/GR/IE/IT/ NL/PT/ES

UK 26-Mar-07



UK 26-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 12/153



UK 26-Mar-07




UK 24-Jan-07




UK 24-Jan-07

B&S Healthcare 05-Oct-06 Acomplia 20mg Film-coated tablets

28 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 17-Jan-07



UK/IE 17-Jan-07



UK/IE 17-Jan-07

G-Pharma 27-Dec-06 Actos 15mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/LI/LU/MT/NL/NO/PT/ES/SE

UK 9-Mar-07

SRL Pharmaceuticals

22-Dec-06 Actos 15mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 10-Apr-07

B&S Healthcare 08-Nov-07 Actos 30mg Tablets 28 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 13-Dec-07

G-Pharma 08-Dec-06 Actos 30mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/LI/LU/MT/NL/NO/PT/ES/SE

UK 9-Mar-07

Paranova AS 12-Jan-06 Actos 30mg Tablets 98 BE/FI/FR/DE/NL/PT/ES/ SE

DK 21-Aug-07

Pharma Gerke 18-Jun-07 Actos 30mg Tablets 28 AT/BE/FR/GR/IT/NL/NO/PT/ES/UK

DE 5-Jul-07

Pharma Gerke 18-Jun-07 Actos 30mg Tablets 98 AT/BE/FR/GR/IT/NL/NO/PT/ES/UK

DE 5-Jul-07

SRL Pharmaceuticals

14-Mar-06 Actos 30mg Tablets 28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK 3-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 13/153


15-Nov-06 Actos 30mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 24-Jul-07

Intercare 09-Feb-07 Actos 45mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 2-Aug-07

Fisher Farma 28-Dec-06 Actraphane 40 Penfill

100IU/ml Suspension for injection in a cartridge

5x3ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 30-Jan-07

Pharma Westen 19-Sep-06 Actrapid Innolet 100IU/ml Solution for injection in a pre-filled pen

5 pens AT/BE/CY/CZ/DK/EE/ GR/ES/FI/FR/HU/IE/IS/ IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE/UK

DE 24-Jan-07

Pharma Westen 19-Sep-06 Actrapid Innolet 100IU/ml Solution for injection in a pre-filled pen


DE 24-Jan-07


23-Mar-07 Actrapid Penfill 100IU/ml Solution for injection in a cartridge

5x3ml AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 26-May-07

Emra-Med 21-Sep-07 Advate 1000IU Powder and solvent for solution for injection

1+1+1 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DE 24-Oct-07

Emra-Med 21-Sep-07 Advate 1500IU Powder and solvent for solution for injection

1+1+1 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DE 24-Oct-07

G-Pharma 06-Jun-06 Aerius 0.5mg/ml Syrup 100ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 19-Jan-07

G-Pharma 02-May-07 Aerius 0.5mg/ml Syrup 120ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 18-Jul-07

SinGad Pharma ApS

08-Aug-07 Aerius 0.5mg/ml Syrup 120ml ES DK 30-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 14/153


23-Jan-06 Aerius 0.5mg/ml Syrup 1 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 31-Aug-07

Waymade 21-May-07 Aerius 0.5mg/ml Syrup 120ml AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 1-Jun-07

Allpharm 06-Mar-06 Aerius 5mg Film-coated tablets

20 GR DE 6-Jul-07

Allpharm 06-Mar-06 Aerius 5mg Film-coated tablets

50 GR DE 6-Jul-07

Chemilines Ltd 24-May-07 Aerius 5mg Film-coated tablets


UK/IE 16-Jul-07



UK/IE 16-Jul-07



UK/IE 16-Jul-07

Colorama 27-Nov-06 Aerius 5mg Film-coated tablets


UK 27-Mar-07

Colorama 27-Nov-06 Aerius 5mg Film-coated tablets


UK 27-Mar-07

G-Pharma 14-Mar-07 Aerius 5mg Film-coated tablets


UK 20-Jul-07

G-Pharma 16-May-07 Aerius 5mg Film-coated tablets


UK 17-Sep-07

Mediport 18-Apr-07 Aerius 5mg Film-coated tablets

20 AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 28-May-07

SinGad Pharma ApS

15-Jun-07 Aerius 5mg Film-coated tablets

100 ES DK 31-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 15/153

Fisher Farma 13-Feb-06 Aerius 0.5mg/ml Syrup 120ml AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/PT/ES/ SE/UK

NL 5-Jan-07

Beragena 23-May-07 Aldara 5% Cream in sachets 12 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 30-Nov-07

Euroregistratie BV 23-Apr-07 Aldara 5% Cream in sachets 12 AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 14-Jun-07

Fisher Farma 23-Nov-06 Aldara 5% Cream in sachets 12 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 15-Jan-07

PCO Ltd 18-Oct-07 Aldara 5% Cream in sachets 12 AT/BE/CY/DK/FI/FR/DE/GR/IT/LU/MT/NL/PT/ ES/SE/UK

UK/IE 13-Nov-07

Pharma Gerke 07-Nov-06 Aldara 5% Cream in sachets 12 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 5-Nov-07

Pharma Westen 03-Jan-07 Aldara 5% Cream in sachets 12 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 28-Mar-07

Pharmachim AB 06-Nov-07 Aldara 5% Cream in sachets 12 AT/BE/FR/DE/GR/IT/NL/PT/ES/UK

SE 13-Dec-07

World Health Limited

21-Dec-06 Aldara 5% Cream in sachets 12 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 26-Jan-07

Medico Pharm 06-Jun-07 Aloxi 250µg Solution for injection

1 vial x 5 ml

AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/PT/ES/SE/UK

DE 5-Jul-07

Emra-Med 11-Jun-07 Apidra 100IU/ml Solution for injection in a cartridge

3 IT DE 5-Nov-07


6 IT DE 5-Nov-07


9 IT DE 5-Nov-07

EMEA/311899/2008 © EMEA 2008 Page 16/153

Colorama 05-Oct-06 Aprovel 150mg Film-coated tablets


UK 1-Aug-07

Delphi BV 03-Nov-06 Aprovel 150mg Film-coated tablets

28 AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 21-Mar-07

Intercare 02-Feb-07 Aprovel 150mg Film-coated tablets


UK/IE 26-Apr-07

Intercare 02-Mar-06 Aprovel 150mg Film-coated tablets

28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK/IE 2-Apr-07

Paranova AS 04-Jul-07 Aprovel 150mg Film-coated tablets

98 DE/NO/ES/UK DK 25-Sep-07

Pharmaco Dane 30-Mar-07 Aprovel 150mg Film-coated tablets

28 IE/ES/UK DK 12-Dec-07




28 IE/ES/UK SE 12-Dec-07



Delphi BV 03-Nov-06 Aprovel 300mg Film-coated tablets


NL 21-Mar-07

Eureco-Pharma B.V.

06-Sep-06 Aprovel 300mg Film-coated tablets

28 FR NL 10-Jan-07

Intercare 02-Mar-06 Aprovel 300mg Film-coated tablets


UK/IE 30-Jan-07



UK/IE 26-Apr-07





EMEA/311899/2008 © EMEA 2008 Page 17/153





Chemilines Ltd 08-Feb-07 Aprovel 75mg Film-coated tablets


UK 5-Apr-07

G-Pharma 30-Jun-06 Aprovel 75mg Film-coated tablets


UK 19-Jun-07

Intercare 29-Mar-05 Aprovel 75mg Tablets 28 AT/BE/DK/FI/FR/DE/GR/IE/IT/NL/PT/ES/SE

UK 25-Jan-07



UK/IE 26-Apr-07

Interport 23-Oct-07 Aprovel 75mg Tablets 84 BE/FR/GR/IT/NL/PT/ES UK 20-Nov-07

Euroregistratie BV 21-Nov-06 Aranesp 10µg Solution for injection in a pre-filled syringe


NL 6-Mar-07



NL 6-Mar-07

CC Pharma 05-Dec-06 Aranesp 15µg Solution for injection in a pre-filled syringe

4 AT/BE/FR/IT/NO/PT/ES/ UK

DE 19-Nov-07

Kohlpharma 01-Dec-06 Aranesp 15µg Solution for injection in a pre-filled syringe

4 AT/BE/FR/FR/IE/IT/NL/NO/PT/ES/SE/UK

DE 26-Apr-07

Paranova AB 25-Jun-07 Aranesp 150µg Solution for injection in a pre-filled syringe

4 AT/GR SE 13-Aug-07



NL 6-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 18/153



NL 6-Mar-07

Orifarm AB 14-Sep-07 Aranesp 20µg Solution for injection in a pre-filled syringe

4 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/NL/UK

SE 25-Sep-07



NL 6-Mar-07



SE 25-Sep-07

Axicorp Pharma 21-May-07 Aranesp 300µg Solution for injection in a pre-filled syringe (non-blister)

1 AT/BE/DK/FI/FR/GR/IS/ IE/LU/NL/NO/PT/ES/SE/UK

DE 7-Aug-07



NL 6-Mar-07

Kohlpharma 16-Oct-06 Aranesp 300µg Solution for injection in a prefilled syringe


DE 16-Jan-07



SE 25-Sep-07

Paranova AB 25-Jun-07 Aranesp 300µg Solution for injection in a pre-filled syringe

1 AT/FR/GR/IT SE 13-Aug-07



NL 6-Mar-07



SE 25-Sep-07



NL 6-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 19/153



SE 25-Sep-07

Axicorp Pharma 21-May-07 Aranesp 500µg Solution for injection in a pre-filled syringe (non-blister)

1 AT/BE/DK/FI/FR/GR/IS/ IE/LU/NL/NO/PT/ES/SE/UK

DE 7-Aug-07



NL 6-Mar-07



NL 6-Mar-07



SE 25-Sep-07



NL 6-Mar-07

Fisher Farma 01-Jun-06 Aranesp SureClick

100µg Solution for injection in a pre

1 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/PT/ES/ SE/UK

NL 19-Jan-07

Pharma Westen 01-Sep-06 Aranesp SureClick


1 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 25-Apr-07




NL 19-Jan-07




DE 25-Apr-07

Pharma Gerke 22-Feb-06 Aranesp SureClick


1 NO DE 5-Mar-07

Euroregistratie BV 21-Nov-06 Aranesp SureClick



NL 15-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 20/153




NL 19-Jan-07




DE 25-Apr-07




NL 19-Jan-07

Kohlpharma 30-Jul-07 Aranesp Sureclick



DE 17-Aug-07

Kohlpharma 30-Jul-07 Aranesp Sureclick



DE 11-Sep-07




DE 25-Apr-07




NL 15-Feb-07




NL 19-Jan-07




DE 25-Apr-07




NL 19-Jan-07

Kohlpharma 12-Feb-07 Aranesp SureClick



DE 28-Sep-07




DE 25-Apr-07

Pharma Gerke 22-Feb-06 Aranesp SureClick


1 NO DE 5-Mar-07




NL 15-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 21/153




NL 19-Jan-07




DE 25-Apr-07




NL 19-Jan-07




DE 25-Apr-07

BR Lewis 31-Jul-07 Arava 10mg Film-coated tablets

30 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/NL/ NO/PT/ES/SE/UK

UK/IE/MT 7-Aug-07

Emra-Med 11-Apr-07 Arava 10mg Film-coated tablets

30 ES DE 13-Jul-07


03-Oct-05 Arava 10mg Film-coated tablets


UK 14-Aug-07


10-Jan-07 Arava 10mg Film-coated tablets

30 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 10-May-07

BR Lewis 19-Dec-06 Arava 20mg Film-coated tablets


UK/IE/MT 29-Jan-07

Delfarma 13-Sep-07 Arava 20mg Film-coated tablets

30 AT/BE/BG/CY/CZ/DK/ EE/FI/FR/DE/GR/HU/IS/ IE/IT/LV/LI/LT/LU/MT/NL/NO/PT/RO/SK/SI/ES/SE/UK

PL 9-Oct-07

Pharma Gerke 18-Dec-06 Arava 20mg Film-coated tablets

30 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 7-Feb-07

Pharma Gerke 06-Oct-06 Arava 20mg Film-coated tablets


DE 10-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 22/153

Stephar (UK) Ltd 15-Dec-06 Arava 20mg Film-coated tablets

30 BE/FR/DE/GR/IT/NL/PT/ ES

UK 5-Feb-07


10-Aug-07 Arava 20mg Film-coated tablets

30 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PL/PT/SK/SI/ES/SE

UK 5-Nov-07


06-Nov-06 Arava 20mg Film-coated tablets


UK 8-Mar-07

Kohlpharma 01-Dec-06 Arava 10mg Film-coated tablets


DE 26-Jan-07

B&S Healthcare 09-Oct-06 Ariclaim 40mg Hard capsules 28 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 6-Nov-07

Pharma Gerke 23-Apr-07 Arixtra 10 mg/0.8 ml Solution for injection in a pre-filled syringe

7 AT/BE/FR/GR/IT/NL/NO/PT/ES/UK

DE 6-Aug-07

Beragena 20-Aug-07 Avaglim 8/4mg Film-coated tablets

112 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 5-Nov-07

Emra-Med 06-Aug-07 Avaglim 8/4mg Film-coated tablets

112 AT DE 5-Nov-07

Pharma Westen 11-Apr-07 Avaglim 8/4mg Film-coated tablets


DE 30-Aug-07

Pharma Westen 11-Apr-07 Avaglim 8/4mg Film-coated tablets


DE 30-Aug-07

Beragena 03-Apr-07 Avaglim 8/4mg Film-coated tablets


DE 5-Nov-07

Paranova AB 21-Sep-06 Avandamet 1/500mg Film-coated tablets

112 AT/BE/FI/FR/DE/GR/IT/NL/PT/ES/UK

SE 2-Jul-07

PCO Ltd 10-May-07 Avandamet 1/500mg Film-coated tablets

112 AT/BE/CY/DK/FI/FR/DE/GR/IT/LU/MT/NL/PT/ ES/SE/UK

UK/IE 14-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 23/153

Beta Kbix Ltd 31-Oct-06 Avandamet 2/1000mg Film-coated tablets


UK 6-Nov-07

Colorama 27-Mar-06 Avandamet 2/1000mg Film-coated tablets


UK 1-Aug-07

Dowelhurst Ltd 01-Dec-06 Avandamet 2/1000mg Film-coated tablets


UK 17-Jan-07

Ginova 21-Nov-06 Avandamet 2/1000mg Film-coated tablets


UK 22-Jan-07

G-Pharma 02-Jun-06 Avandamet 2/1000mg Film-coated tablets


UK 23-Jan-07

Intercare 21-Feb-07 Avandamet 2/1000mg Film-coated tablets

168 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 12-Apr-07

Mediport 10-May-07 Avandamet 2/1000mg Film-coated tablets


UK 17-Aug-07

N.G. Ltd 03-May-05 Avandamet 2/1000mg Film-coated tablets


UK 9-Aug-07

Pharma Westen 17-Jul-06 Avandamet 2/1000mg Film-coated tablets


DE 13-Sep-07

Polyfarma Ltd 20-Aug-07 Avandamet 2/1000mg Film-coated tablets


UK/IE 2-Oct-07

Beragena 09-Jan-06 Avandamet 2/500mg Film-coated tablets

112 ES DE 18-Jun-07



UK 6-Nov-07

EMEA/311899/2008 © EMEA 2008 Page 24/153

BR Lewis 05-Jan-07 Avandamet 2/500mg Film-coated tablets


UK/IE/MT 10-Apr-07

Chemilines Ltd 14-Nov-07 Avandamet 2/500mg Film-coated tablets

28 AT/BE/CY/DK/FI/FR/GR/IS/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK/IE 18-Dec-07



UK/IE 18-Dec-07



UK/IE 18-Dec-07



UK 1-Aug-07

Euroregistratie BV 25-Oct-06 Avandamet 2/500mg Film-coated tablets


NL 10-Apr-07

Ginova 04-Dec-06 Avandamet 2/500mg Film-coated tablets


UK 15-Feb-07

Lexon 30-Apr-07 Avandamet 2/500mg Film-coated tablets


UK 6-Jun-07



UK 17-Aug-07



UK 9-Aug-07

Paranova AB 21-Sep-06 Avandamet 2/500mg Film-coated tablets

112 AT/BE/FI/FR/DE/GR/IT/NL/PT/ES/UK

SE 2-Jul-07



UK/IE 14-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 25/153



UK/IE 14-Jun-07


01-Dec-06 Avandamet 2/500mg Film-coated tablets

112 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/PT/ES/SE

UK 7-Aug-07



UK 6-Nov-07



UK 1-Aug-07

GenPlus Ltd 06-Mar-07 Avandamet 4/1000mg Film-coated tablets

56 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 6-Aug-07

Ginova 23-Nov-06 Avandamet 4/1000mg Film-coated tablets

56 AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 15-Feb-07

Intercare 21-Feb-07 Avandamet 4/1000mg Film-coated tablets


UK/IE 12-Apr-07



UK 17-Aug-07



UK 9-Aug-07

Paranova A/S 21-Feb-07 Avandamet 4/1000mg Film-coated tablets

56 AT/BE/FI/FR/DE/GR/IT/NL/ES/SE/UK

DK 2-Mar-07

Paranova Oy 03-Apr-05 Avandamet 4/1000mg Film-coated tablets

56 AT/ES FI 9-Aug-07

Polyfarma Ltd 20-Aug-07 Avandamet 4/1000mg Film-coated tablets


UK/IE 2-Oct-07


13-Nov-06 Avandamet 4/1000mg Film-coated tablets


UK 8-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 26/153

B&S Healthcare 29-Sep-06 Avandia 4mg Film-coated tablets


UK/IE 23-Jan-07

Colorama 10-Jul-07 Avandia 4mg Film-coated tablets


UK 7-Aug-07

Colorama 10-Jul-07 Avandia 4mg Film-coated tablets


UK 8-Oct-07

Delphi BV 03-Nov-06 Avandia 4mg Film-coated tablets


NL 23-Apr-07

Dowelhurst Ltd 14-Feb-07 Avandia 4mg Film-coated tablets

56 AT/BE/CY/DK/EE/FI/FR/ DE/GR/IS/IE/IT/LI/LU/ MT/NL/NO/PL/ES/SE

UK 8-Mar-07

GenPlus Ltd 09-Aug-07 Avandia 4mg Film-coated tablets


UK 4-Dec-07

G-Pharma 28-Feb-07 Avandia 4mg Film-coated tablets


UK 2-Apr-07

Intercare 05-Jul-07 Avandia 4mg Film-coated tablets


UK/IE 17-Aug-07

N.G. Ltd 21-Dec-05 Avandia 4mg Film-coated tablets


UK 15-Jan-07

Polyfarma Ltd 30-Mar-06 Avandia 4mg Film-coated tablets


UK/IE 16-Jan-07


22-Aug-06 Avandia 4mg Film-coated tablets


UK 24-Jan-07


26-Apr-07 Avandia 4mg Film-coated tablets


UK 7-Jun-07

Waymade 01-Mar-07 Avandia 4mg Film-coated tablets

56x1 AT/BE/FR/DE/GR/IT/NL/NO/PT/ES

UK 23-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 27/153

G-Pharma 29-Nov-06 Avandia 4mg Film-coated tablets


UK 22-Jan-07

Delphi BV 03-Jul-07 Avandia 8mg Film-coated tablets


NL 3-Aug-07

G-Pharma 18-Jan-07 Avandia 8mg Film-coated tablets


UK 22-Jan-07

N.G. Ltd 11-Apr-07 Avandia 8mg Film-coated tablets


UK 29-May-07

N.G. Ltd 11-Apr-07 Avandia 8mg Film-coated tablets


UK 29-May-07


11-Sep-06 Avandia 8mg Film-coated tablets

112 AT/BE/CY/CZ/DK/FR/ DE/GR/IE/IT/MT/NL/NO/PO/PT/ES/SE

UK 5-Mar-07

Opal Healthcare Ltd 12-Apr-07 Avandia 8mg Film-coated tablets


UK 17-Jul-07

Orifarm OY 16-Apr-07 Avandia 8mg Film-coated tablets

112 AT/BE/CY/DK/FR/DE/ GR/IS/IE/LI/LU/MT/NO/PT/ES/SE/NL/UK

FI 3-Aug-07

Orifarm OY 16-Apr-07 Avandia 8mg Film-coated tablets

28 AT/BE/CY/DK/FR/DE/ GR/IS/IE/LI/LU/MT/NO/PT/ES/SE/NL/UK

FI 3-Aug-07

CC Pharma 05-Mar-07 Avastin 25mg/ml Concentrate for solution for infusion

1x16ml AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 23-Mar-07

CC Pharma 05-Mar-07 Avastin 25mg/ml Concentrate for solution for infusion

1x4ml AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 7-May-07

Beragena 04-Jul-06 Avonex 30µg Powder and solvent for solution for injection

4+4 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 7-Dec-07

EMEA/311899/2008 © EMEA 2008 Page 28/153

CC Pharma 15-Oct-07 Avonex 30µg Solution for injection in a pre-filled syringe

12 NO DE 22-Oct-07

Cross Pharma AB 04-Apr-07 Avonex 30µg Solution for injection in a pre-filled syringe

4 FR/GR/IT/NL/NO/ES SE 18-Apr-07

Cross Pharma AB 01-Feb-07 Avonex 30µg Powder and solvent for solution for injection

4+4 BE/NO SE 20-Jun-07

Fisher Farma 08-Aug-06 Avonex 30µg Powder and solvent for solution for injection - Bioset

4+4 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 19-Apr-07

Paranova AB 05-Feb-07 Avonex 30µg Solution for injection in a pre-filled syringe

4 AT/BE/FI/DE/GR/NL/UK SE 27-Apr-07

Beragena 02-Jan-07 Avonex 30µg Solution for injection in a pre-filled syringe


DE 7-Dec-07

Intercare 07-Aug-07 Azilect 1mg Tablets 30 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 17-Aug-07

Medcor BV (Lepharma)

20-Jun-07 Azilect 1mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 7-Aug-07

Mediport 08-Jun-07 Azilect 1mg Tablets 28 AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 18-Jul-07

Ivax AB 03-Jan-07 Azopt 10mg/ml Eye drops suspension

3 AT/BE/DK/FI/FR/DE/GR/IE/IT/NL/PT/ES/UK

SE 15-May-07

Mediport 11-May-07 Azopt 10mg/ml Eye drops suspension


UK 8-Jun-07

Qdoxx Pharma AB 27-Dec-06 Azopt 10mg/ml Eye drops suspension

3 GR SE 10-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 29/153


15-Feb-07 Azopt 10mg/ml Eye drops suspension


UK 30-May-07


09-Aug-07 Baraclude 0.5mg Film-coated tablets

30 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 9-Oct-07

Euroregistratie BV 23-Oct-07 Baraclude 1mg Film-coated tablets

30 AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 23-Nov-07

Fisher Farma 08-Mar-07 Baraclude 1mg Film-coated tablets


NL 18-Jul-07

CC Pharma 10-May-07 Betaferon 250µg/ml Powder and solvent for solution for injection

15+15 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 23-Oct-07

Medartuum AB 01-Dec-06 Betaferon 250µg/ml Powder and solvent for solution for injection

15 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 31-Jul-07

Medico Pharm 14-Jul-06 Betaferon 250µg/ml Powder and solvent for solution for injection

15 AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/PT/ES/SE/UK

DE 24-Jan-07

Pharma Westen 28-Feb-07 Bondronat 2mg Concentrate for solution for infusion


DE 17-May-07

Intercare 16-Apr-07 Bondronat 50mg Film-coated tablets


UK/IE 14-Jun-07


12-Mar-07 Bonviva 150mg Film-coated tablets

1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/ES/SE/UK

UK/IE 20-Jul-07




UK/IE 20-Jul-07

AxiCorp Pharma 25-Sep-07 Bonviva 150mg Film-coated tablets


DE 16-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 30/153

AxiCorp Pharma 25-Sep-07 Bonviva 150mg Film-coated tablets


DE 16-Oct-07

BR Lewis 08-Feb-07 Bonviva 150mg Film-coated tablets


UK/IE/MT 18-Jul-07

CC Pharma 21-May-07 Bonviva 150mg Film-coated tablets

1 AT/BE/FR/GR/IT/NO/PT/ UK

DE 20-Aug-07

CC Pharma 21-May-07 Bonviva 150mg Film-coated tablets

3 AT/BE/FR/GR/IT/NO/PT/ UK

DE 20-Aug-07

Chemilines Ltd 15-Jun-07 Bonviva 150mg Film-coated tablets

1 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PL/PT/ES/SE

UK/IE 23-Oct-07

Dowelhurst Ltd 12-Jun-07 Bonviva 150mg Film-coated tablets


UK 10-Aug-07

Fisher Farma 03-May-06 Bonviva 150mg Film-coated tablets

1 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/PT/ES/ UK

NL 9-Jan-07

Fisher Farma 03-May-06 Bonviva 150mg Film-coated tablets

3 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/PT/ES/ UK

NL 9-Jan-07

GenPlus Ltd 27-Apr-07 Bonviva 150mg Film-coated tablets


UK 5-Nov-07

GenPlus Ltd 24-Sep-07 Bonviva 150mg Film-coated tablets

1 AT/BE/CZ/DK/FI/FR/DE/ GR/IE/IT/LU/MT/NL/PT/ ES/SE

UK 22-Nov-07

G-Pharma 01-Aug-07 Bonviva 150mg Film-coated tablets

1 AT/BE/CY/DK/FI/FR/DEGR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE

UK 13-Aug-07

G-Pharma 07-Sep-07 Bonviva 150mg Film-coated tablets


UK 24-Oct-07

Intercare 19-Feb-07 Bonviva 150mg Film-coated tablets


UK/IE 9-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 31/153

Intercare 15-Feb-07 Bonviva 150mg Film-coated tablets


UK/IE 9-Mar-07

Lexon 04-May-07 Bonviva 150mg Film-coated tablets


UK 6-Jul-07


02-Jun-06 Bonviva 150mg Film-coated tablets


NL 30-Jan-07


02-Jun-06 Bonviva 150mg Film-coated tablets


NL 30-Jan-07

N.G. Ltd 21-May-07 Bonviva 150mg Film-coated tablets


UK 17-Dec-07


25-Apr-07 Bonviva 150mg Film-coated tablets


UK 30-Aug-07


16-Feb-07 Bonviva 150mg Film-coated tablets


UK 30-Aug-07

Orifarm AS 08-Jun-07 Bonviva 150mg Film-coated tablets

1 AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 29-Nov-07

Orifarm AS 08-Jun-07 Bonviva 150mg Film-coated tablets


DK 29-Nov-07

Paranova AS 28-Jun-07 Bonviva 150mg Film-coated tablets

3 AT/BE/FI/DE/GR/IT/NL/ NO/PT/ES/SE/UK

DK 25-Sep-07

Pharma Westen 03-Aug-06 Bonviva 150mg Film-coated tablets

1 AT/BE/CY/CZ/DK/EE/ GR/ES/FI/FR/HU/IE/IS/ IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE/UK

DE 1-Mar-07

Pharma Westen 03-Aug-06 Bonviva 150mg Film-coated tablets


DE 1-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 32/153


17-Jan-07 Bonviva 150mg Film-coated tablets

1 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 14-Feb-07

Waymade 24-Apr-07 Bonviva 150mg Film-coated tablets


UK 30-Apr-07

Waymade 14-Feb-07 Bonviva 150mg Film-coated tablets


UK 18-Apr-07


7-Aug-07 Bonviva 150mg Film-coated tablets


UK 15-Aug-07




UK 8-Aug-07


14-Aug-07 Caelyx 2mg/ml Concentrate for solution for infusion


UK 23-Aug-07

CC Pharma 21-Nov-06 Cellcept 250mg Hard capsules 100 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 5-Feb-07

CC Pharma 21-Nov-06 Cellcept 250mg Hard capsules 300 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 5-Feb-07

Pharma Westen 07-Nov-05 Cellcept 250mg Hard capsules 300 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 12-Jul-07

Pharma Westen 07-Nov-05 Cellcept 250mg Hard capsules 100 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 12-Jul-07

CC Pharma 21-Nov-06 Cellcept 500mg Tablets 50 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 9-Feb-07

CC Pharma 21-Nov-06 Cellcept 500mg Tablets 150 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 9-Feb-07

Delphi BV 03-Nov-06 Cellcept 500mg Tablets 50 AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 10-May-07

Eureco-Pharma B.V.

14-Apr-05 Cellcept 500mg Tablets 50 GR/ES NL 5-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 33/153


26-Mar-07 Cellcept 500mg Tablets 50 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 4-Apr-07

Pharma Westen 07-Nov-05 Cellcept 500mg Tablets 150 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 12-Jul-07

Pharma Westen 07-Nov-05 Cellcept 500mg Tablets 50 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 12-Jul-07


12-Dec-06 Champix 0.5mg Film-coated tablets

56 in bottle

AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE/UK

UK/IE 30-May-07

Dowelhurst Ltd 09-Jul-07 Champix 0.5mg Film-coated tablets

56 AT/BE/CZ/CY/HU/DK/ DE/EE/GR/ES/FI/FR/IE/ IT/IS/LI/LV/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 31-Jul-07

Fisher Farma 17-Jul-07 Champix 0.5mg Film-coated tablets


NL 7-Aug-07

Intercare 16-Apr-07 Champix 0.5mg Film-coated tablets


UK/IE 21-May-07


20-Jul-07 Champix 0.5mg Film-coated tablets


UK 5-Nov-07


12-Dec-06 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 in card


UK/IE 30-May-07

B&S Healthcare 14-Sep-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 14-Nov-07

BR Lewis 12-Mar-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/NL/ NO/PT/ES/SE/UK

UK/IE/MT 7-May-07

Dowelhurst Ltd 09-Jul-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CZ/CY/HU/DK/ DE/EE/GR/ES/FI/FR/IE/ IT/IS/LI/LV/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 31-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 34/153

Euroregistratie BV 19-Jul-07 Champix 0.5mg + 1mg Film-coated tablets

11+14 AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 9-Aug-07

GenPlus Ltd 24-May-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE/UK

UK 1-Aug-07

Intercare 11-Jun-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CY/DK/FI/FR/DE/GR/IE/LU/MT/NL/PT/ ES/SE

UK/IE 27-Jun-07

Interport 05-Nov-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 13-Dec-07

Lexon 29-Oct-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 19-Dec-07

Pharma Westen 29-Aug-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CZ/DK/FI/FR/GR/IS/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 21-Sep-07


16-May-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 13-Jul-07

Waymade 28-Aug-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CZ/FR/DE/GR/IT/ NL/NO/PT/ES

UK 10-Sep-07

Fisher Farma 17-Jul-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 7-Aug-07


25-Jul-07 Champix 0.5mg + 1mg Film-coated tablets

11 + 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 7-Aug-07


12-Dec-06 Champix 1mg Film-coated tablets

28 in card


UK/IE 30-May-07

CST Pharma Ltd 18-Jun-07 Champix 1mg Film-coated tablets


UK 4-Dec-07

EMEA/311899/2008 © EMEA 2008 Page 35/153

CST Pharma Ltd 18-Jun-07 Champix 1mg Film-coated tablets


UK 4-Dec-07

Dowelhurst Ltd 09-Jul-07 Champix 1mg Film-coated tablets

28 AT/BE/CZ/CY/HU/DK/ DE/EE/GR/ES/FI/FR/IE/ IT/IS/LI/LV/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 31-Jul-07

Euroregistratie BV 19-Jul-07 Champix 1mg Film-coated tablets


NL 9-Aug-07

Fisher Farma 17-Jul-07 Champix 1mg Film-coated tablets


NL 7-Aug-07

Intercare 11-Jun-07 Champix 1mg Film-coated tablets

28 AT/BE/CY/DK/FI/FR/DE/GR/IE/LU/MT/NL/PT/ ES/SE

UK/IE 27-Jun-07


25-Jul-07 Champix 1mg Film-coated tablets


NL 7-Aug-07

Pharma Westen 29-Aug-07 Champix 1mg Film-coated tablets

28 AT/BE/CZ/DK/FI/FR/GR/IS/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 21-Sep-07

Waymade 28-Aug-07 Champix 1mg Film-coated tablets

28 AT/BE/CZ/FR/DE/GR/IT/ NL/NO/PT/ES

UK 10-Sep-07

Waymade 20-Sep-07 Champix 1mg Film-coated tablets

56 AT/BE/CZ/FR/DE/GR/IT/ NL/NO/PT/ES

UK 15-Oct-07

BR Lewis 26-Oct-06 Cialis 10mg Film-coated tablets

4 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

UK/IE/MT 8-Feb-07

Delphi BV 23-Jul-07 Cialis 10mg Film-coated tablets


NL 28-Sep-07

Ginova 15-Sep-06 Cialis 10mg Film-coated tablets


UK 29-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 36/153

Orifarm AS 02-Jul-07 Cialis 10mg Film-coated tablets

4 AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/NL/PT/ES/SE/UK

DK 8-Aug-07

Orifarm OY 02-Jul-07 Cialis 10mg Film-coated tablets

4 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE/UK

FI 8-Aug-07

Paranova Oy 04-Apr-07 Cialis 10mg Film-coated tablets

4 AT/BE/FR/DE/GR/IT/PT/ ES/UK

FI 17-Apr-07

Pharmaco Dane 04-Jan-07 Cialis 10mg Film-coated tablets

4 GR DK 5-Nov-07


15-Feb-07 Cialis 10mg Film-coated tablets


UK 11-Apr-07

BR Lewis 19-Feb-07 Cialis 20mg Film-coated tablets

4 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

UK/IE/MT 26-Apr-07

BR Lewis 28-Aug-07 Cialis 20mg Film-coated tablets


UK/IE/MT 4-Sep-07

CC Pharma 24-Oct-07 Cialis 20mg Film-coated tablets


DE 5-Nov-07

Delphi BV 23-Jul-07 Cialis 20mg Film-coated tablets


NL 28-Sep-07

Euroregistratie BV 17-Nov-06 Cialis 20mg Film-coated tablets


NL 8-Jan-07

Forfarm 24-Apr-06 Cialis 20mg Film-coated tablets


PL 23-Nov-07

G-Pharma 23-Aug-07 Cialis 20mg Film-coated tablets


UK 6-Dec-07

Paranova AB 29-May-07 Cialis 20mg Film-coated tablets

4 AT/BE/FI/FR/GR/IT/NL/PT/ES/UK

SE 14-Sep-07

Paranova AS 11-Dec-06 Cialis 20mg Film-coated tablets

8 AT/BE/FI/FR/DE/GR/IT/ NO/ES/SE

DK 3-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 37/153


4 AT/BE/FR/DE/GR/IT/PT/ UK

FI 17-Apr-07



FI 17-Apr-07



FI 17-Apr-07

Pharma Gerke 12-Jan-07 Cialis 20mg Film-coated tablets

12 AT/BE/FR/CZ/GR/IT/NO/PT/ES/UK

DE 19-Feb-07

Pharma Gerke 12-Jan-07 Cialis 20mg Film-coated tablets

4 AT/BE/FR/CZ/GR/IT/NO/PT/ES/UK

DE 19-Feb-07

Pharma Westen 25-Jan-06 Cialis 20mg Film-coated tablets


DE 15-May-07



DE 15-May-07



DE 15-May-07


4 GR DK 5-Nov-07


8 GR DK 5-Nov-07


4 GR SE 5-Nov-07


8 GR SE 5-Nov-07


12 GR SE 5-Nov-07


04-Apr-07 Cialis 20mg Film-coated tablets


UK 21-Sep-07


04-Apr-07 Cialis 20mg Film-coated tablets


UK 21-Sep-07

EMEA/311899/2008 © EMEA 2008 Page 38/153

SinGad Pharma ApS

11-Dec-06 Cialis 20mg Film-coated tablets

8 GR/UK DK 20-Feb-07




UK 11-Apr-07




UK 11-Apr-07

G-Pharma 27-Sep-06 CoAprovel 150/12,5mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 18-Apr-07

Emra-Med 16-Apr-07 CoAprovel 150/12.5mg Tablets 28 IT DE 20-Aug-07

Emra-Med 16-Apr-07 CoAprovel 150/12.5mg Tablets 56 IT DE 20-Aug-07

Ginova 17-Aug-07 CoAprovel 150/12.5mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 17-Oct-07

Pharmaco Dane 09-Mar-07 CoAprovel 150/12.5mg Tablets 98 IE/ES/UK DK 14-Aug-07

Pharmaco Dane 09-Mar-07 CoAprovel 150/12.5mg Tablets 98 IE/ES/UK SE 14-Aug-07

G-Pharma 23-Oct-06 CoAprovel 300/12.5 mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 11-Jan-07

Ginova 17-Aug-07 CoAprovel 300/12.5mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 17-Oct-07

Pharmaco Dane 09-Mar-07 CoAprovel 300/12.5mg Tablets 98 IE/ES/UK DK 14-Aug-07

Pharmaco Dane 09-Mar-07 CoAprovel 300/12.5mg Tablets 98 IE/ES/UK SE 14-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 39/153

Emra-Med 05-Nov-07 CoAprovel 300/25mg Film-coated tablets

28 AT/BE/CY/CZ/DK/EE/FI/FR/GR/HU/IE/IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SK/SI/ES/SE/UK

DE 7-Dec-07

Euroregistratie BV 18-Apr-07 CoAprovel 300/25mg Film-coated tablets


NL 21-May-07

Kohlpharma 30-May-07 CoAprovel 300/25mg Film-coated tablets


DE 1-Aug-07

Kohlpharma 14-May-07 CoAprovel 300/25mg Film-coated tablets


DE 1-Aug-07

Kohlpharma 27-Jun-07 CoAprovel 300/25mg Film-coated tablets


DE 1-Aug-07


11-Jun-07 CoAprovel 300/25mg Film-coated tablets


NL 9-Oct-07

Orifarm AS 06-Jul-07 CoAprovel 300/25mg Film-coated tablets

28 AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DK 14-Aug-07

Orifarm AS 06-Jul-07 CoAprovel 300/25mg Film-coated tablets


DK 14-Aug-07

Parallell Pharma AB 19-Jun-06 CoAprovel 300mg Film-coated tablets

98 GR/ES SE 7-Sep-07

SinGad Pharma ApS

19-Jun-06 CoAprovel 300mg Film-coated tablets

98 GR/UK DK 30-Mar-07

Colorama 04-Dec-06 CoAprovel 150/12.5mg Film-coated tablets


UK 7-Aug-07

Colorama 04-Dec-06 CoAprovel 300/12.5mg Film-coated tablets


UK 7-Aug-07

CC Pharma 04-Aug-05 Combivir 150/300mg Film-coated tablets

60 BE DE 2-Jul-07

Paranova Oy 12-Feb-07 Combivir 150/300mg Film-coated tablets

60 AT/BE/FR/GR/IT/PT/ES FI 26-Sep-07

EMEA/311899/2008 © EMEA 2008 Page 40/153

Paranova AB 24-May-07 Combivir 150/300mg Film-coated tablets

60 FR/GR/IT/ES SE 11-Sep-07

Pharma Gerke 30-Jan-06 Combivir 150/300mg Film-coated tablets

60 BE/NO DE 2-Mar-07

Intercare 02-May-07 Comtan 200mg Film-coated tablets


UK/IE 21-May-07

Intercare 18-Jul-07 Comtan 200mg Film-coated tablets


UK/IE 7-Aug-07

Beragena 30-Oct-06 Comtess 200mg Film-coated tablets


DE 25-Jun-07

BR Pharma 15-Aug-07 Comtess 200mg Film-coated tablets

60 AT/BE/CY/DK/FI/FR/DE/GR/IT/LU/MT/NL/NO/ PT/ES/SE

UK/IE 3-Oct-07

Docpharm 01-Nov-07 Comtess 200mg Film-coated tablets

100 AT/BE/DK/FI/FR/GR/IE/IT/LU/MT/NL/NO/PT/ES/UK

DE 12-Dec-07

Emra-Med 10-Jul-06 Comtess 200mg Film-coated tablets

100 UK DE 30-Jan-07

Beragena 08-Aug-06 Cymbalta 30mg Hard gastro-resistant capsules


DE 26-Mar-07

CC Pharma 05-Apr-06 Cymbalta 30mg Hard gastro-resistant capsules

28 BE/FR/IT/NO/PT/ES/NL/ UK

DE 26-Apr-07

GenPlus Ltd 31-Mar-06 Cymbalta 30mg Hard gastro-resistant capsules


UK 1-Aug-07

Ginova 11-Jun-07 Cymbalta 30mg Hard gastro-resistant capsules


UK 28-Jun-07

Orifarm A/S 08-Sep-06 Cymbalta 30mg Hard gastro-resistant capsules

28 AT/BE/CY/FR/DE/GR/IE/IT/NO/PT/ES/NL/UK

DK 30-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 41/153

Paranova AS 10-Jan-07 Cymbalta 30mg Hard gastro-resistant capsules

28 AT/FI/DE/GR/NL/NO/ES/SE/UK

DK 17-Apr-07

SRL Pharmaceuticals

03-Mar-06 Cymbalta 30mg Hard gastro-resistant capsules


UK 4-Jan-07


08-Sep-06 Cymbalta 30mg Hard gastro-resistant capsules

28 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PL/PT/SI/SK/ES/SE

UK 14-Feb-07


19-Jul-06 Cymbalta 30mg Hard gastro-resistant capsules

28 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/NL/PT/ES

UK 30-Jan-07

AxiCorp Pharma 11-Oct-06 Cymbalta 60mg Hard gastro-resistant capsules

98 AT/BE/DK/FI/FR/GR/IT/IE/LU/NL/PT/ES/SE/UK

DE 5-Feb-07

AxiCorp Pharma 11-Oct-06 Cymbalta 60mg Hard gastro-resistant capsules

28 AT/BE/DK/FI/FR/GR/IT/IE/LU/NL/NO/PT/ES/SE/UK

DE 5-Feb-07

Beragena 02-Oct-06 Cymbalta 60mg Hard gastro-resistant capsules


DE 26-Mar-07

CC Pharma 20-Nov-06 Cymbalta 60mg Hard gastro-resistant capsules


DE 13-Apr-07

CC Pharma 20-Nov-06 Cymbalta 60mg Hard gastro-resistant capsules


DE 13-Apr-07

Chemilines Ltd 25-May-07 Cymbalta 60mg Hard gastro-resistant capsules


UK 17-Oct-07

Emra-Med 22-Jan-07 Cymbalta 60mg Hard gastro-resistant capsules

98 BE DE 16-Feb-07

Ginova 04-Oct-06 Cymbalta 60mg Hard gastro-resistant capsules


UK 17-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 42/153

G-Pharma 10-May-07 Cymbalta 60mg Hard gastro-resistant capsules

28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PO/PT/ES/SE

UK 15-Aug-07

Mediport 18-Apr-07 Cymbalta 60mg Hard gastro-resistant capsules

28 AT/BE/FR/DE/GR/IT/MT/PT/ES

UK 21-May-07

Orifarm AS 02-Jul-07 Cymbalta 60mg Hard gastro-resistant capsules

28 AT/BE/CY/FI/FR/DE/GR/IE/IS/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 7-Aug-07

Orifarm AS 02-Jul-07 Cymbalta 60mg Hard gastro-resistant capsules

98 AT/BE/CY/FI/FR/DE/GR/IE/IS/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 7-Aug-07

Pharma Gerke 07-Dec-06 Cymbalta 60mg Hard gastro-resistant capsules


DE 3-Apr-07

Pharma Gerke 05-Mar-07 Cymbalta 60mg Hard gastro-resistant capsules


DE 2-Aug-07

SRL Pharmaceuticals

21-Dec-06 Cymbalta 60mg Hard gastro-resistant capsules


UK 8-Mar-07


21-Aug-06 Cymbalta 60mg Hard gastro-resistant capsules

28 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PL/PT/SI/SK/ES/SE

UK 14-Feb-07


14-Sep-06 Cymbalta 60mg Hard gastro-resistant capsules

28 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 30-Jan-07

Orifarm A/S 27-Dec-06 Dukoral - Suspension of vaccine and effervescent granules for oral solution

2x1 AT/BE/CY/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

DK 5-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 43/153

Orifarm AB 27-Dec-06 Dukoral - Suspension of vaccine and effervescent granules for oral solution

2x1 AT/BE/CY/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 27-Feb-07

Paranova AB 04-Sep-06 Dukoral - Suspension and effervescent granules for oral suspension

2x1 UK SE 7-Feb-07

Intercare 16-Oct-07 DuoTrav 40 µg/ml + 5 mg/ml

Eye drops solution

1 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LT/LI/LU/MT/NL/NO/PT/SK/SI/ES/SE

UK/IE 25-Oct-07

Fisher Farma 15-Jun-07 DuoTrav 40 µg/ml + 5 mg/ml

Eye drops solution


NL 31-Jul-07

Waymade 06-Mar-07 DuoTrav 40 µg/ml + 5 mg/ml

Eye drops solution


UK 1-Aug-07

Mediport 24-Apr-07 DuoTrav 40µg/ml + 5mg/ml

Eye drops solution


UK 28-May-07

PCO Ltd 04-Jul-06 Ebixa 10mg Film-coated tablets

28 UK IE 6-Feb-07

PCO Ltd 04-Jul-06 Ebixa 10mg Film-coated tablets

56 UK IE 6-Feb-07

Qdoxx Pharma AB 20-Dec-06 Ebixa 10mg Film-coated tablets

100 GR SE 16-Jul-07

B&S Healthcare 16-Jan-07 Ebixa 10mg Oral Drops, solution

50g AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 28-Mar-07

B&S Healthcare 16-Jan-07 Ebixa 10mg Oral Drops, solution

100g AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 28-Mar-07

B&S Healthcare 13-Dec-06 Ebixa 10mg Film-coated tablets


UK/IE 3-May-07



UK/IE 3-May-07

EMEA/311899/2008 © EMEA 2008 Page 44/153



UK/IE 3-May-07

Emra-Med 20-Sep-07 Emadine 0.05% Eye drops solution

1 AT/BE/CY/CZ/DK/EE/FI/FR/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SK/SI/ES/SE/UK

DE 7-Nov-07

Ginova 16-Aug-06 Emadine 0.05% Eye drops, solution

1x3ml AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 15-Mar-07

G-Pharma 16-Jun-06 Emadine 0.05% Eye drops, solution

1x5ml AT/BE/CY/DK/EE/FI/FR/ DE/GR/HU/IS/IE/IT/LV/LT/LU/MT/NL/NO/PL/ PT/SK/SI/ES/SE

UK 15-Mar-07

Fisher Farma 14-May-07 Emselex 15mg Prolonged release tablets


NL 6-Jun-07


22-Jan-07 Emselex 15mg Prolonged release tablets

28 AT/BE/CY/DK/FI/FR/GR/DE/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 26-Mar-07


17-Sep-07 Emselex 15mg Prolonged release tablets

28 (CTFE)

AT/BE/CY/DK/FI/FR/GR/DE/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 16-Oct-07

CC Pharma 29-May-07 Emtriva 200mg Hard capsules 30 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 25-Jul-07

Delfarma 08-Aug-07 Emtriva 200mg Hard capsules 30 AT/BE/BG/CY/CZ/DK/ ES/FI/FR/DE/GR/HU/IS/ IE/IT/LV/LI/LT/LU/MT/NL/NO/PT/RO/SK/SI/ES/SE/UK

PL 12-Dec-07

Emra-Med 18-Jun-07 Emtriva 200mg Hard capsules 30 BE DE 21-Aug-07

EU-Pharma B.V. 28-Aug-07 Emtriva 200mg Hard capsules 30 AT/BE/FR/DE/GR/IT/PT/ ES/UK

NL 4-Sep-07

Kohlpharma 14-Mar-07 Emtriva 200mg Hard capsules 30 (bottle)

AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 19-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 45/153

Orifarm AB 12-Mar-07 Emtriva 200mg Hard capsules 30 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/NL/UK

SE 10-Aug-07

Orifarm AS 12-Mar-07 Emtriva 200mg Hard capsules 30 AT/BE/CY/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 10-Aug-07

Orifarm OY 12-Mar-07 Emtriva 200mg Hard capsules 30 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NO/PT/ES/SE/NL/UK

FI 10-Aug-07

Pharma Gerke 16-May-07 Emtriva 200mg Hard capsules 30 (bottle)

AT/BE/FR/GR/IT/NL/NO/PT/ES/UK

DE 17-Jul-07

Pharma Westen 03-Sep-07 Emtriva 200mg Hard capsules 30 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 25-Oct-07

AxiCorp Pharma 01-Mar-07 Enbrel 25mg Solution for injection in a pre-filled syringe

4+8 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 10-Apr-07

Beragena 31-Jul-06 Enbrel 25mg Powder and solvent for solution for injection

8+8+8+8+16

AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 15-Nov-07

Beragena 31-Jul-06 Enbrel 25mg Powder and solvent for solution for injection

4+4+4+4+8

AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 15-Nov-07

CC Pharma 15-Jun-06 Enbrel 25mg Powder and solvent for solution for injection

24+24+ 48

FR/GR/NO DE 12-Jan-07

CC Pharma 07-Feb-07 Enbrel 25mg Powder and solvent for solution for injection

4+4+8 NO DE 24-May-07

CC Pharma 18-Jan-07 Enbrel 25mg Solution for injection in a pre-filled syringe


DE 26-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 46/153



DE 26-Jul-07



DE 26-Jul-07

CC Pharma 29-Dec-05 Enbrel 25mg Powder and solvent for solution for injection

4+4+8 GR DE 6-Jul-07

CC Pharma 29-Dec-05 Enbrel 25mg Powder and solvent for solution for injection

8+8+16 GR DE 6-Jul-07

Kohlpharma 27-Apr-07 Enbrel 25mg Solution for injection in a pre-filled syringe

4+8 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 7-Aug-07

Medartuum AB 01-Mar-07 Enbrel 25mg Powder and solvent for solution for injection for paediatric use

4+4+8+20+24

AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 11-Jul-07

Medartuum AB 26-Feb-07 Enbrel 25mg Solution for injection in a pre-filled syringe

4+8 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 11-Jul-07

Medico Pharm 27-Jun-07 Enbrel 25mg Solution for injection in a pre-filled syringe

8+16 AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/PT/ES/SE/UK

DE 17-Jul-07

Medico Pharm 24-May-07 Enbrel 25mg Solution for injection in a pre-filled syringe


DE 8-Aug-07

Orifarm AB 15-Jan-07 Enbrel 25mg Powder and solvent for solution for injection


SE 30-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 47/153

Orifarm AS 15-Jan-07 Enbrel 25mg Powder and solvent for solution for injection


DK 30-Apr-07

Orifarm AS 24-May-07 Enbrel 25mg Solution for injection in a pre-filled syringe

4+8 AT/BE/CY/FI/FR/DE/GR/IE/IS/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 20-Jul-07

Orifarm OY 15-Jan-07 Enbrel 25mg Powder and solvent for solution for injection


FI 30-Apr-07

Pharma Gerke 29-Jan-07 Enbrel 25mg Solution for injection in a pre-filled syringe


DE 12-Jul-07



DE 12-Jul-07



DE 12-Jul-07

Pharma Gerke 28-Feb-06 Enbrel 25mg Powder and solvent for solution for injection

4+4+4+8

FR/GR/NL/NO/PT/ES/ UK

DE 12-Jul-07

Pharma Gerke 28-Feb-06 Enbrel 25mg Powder and solvent for solution for injection

8+8+8+16

FR/GR/NL/NO/PT/ES/ UK

DE 12-Jul-07

Pharma Gerke 15-Sep-06 Enbrel 25mg Powder and solvent for solution for injection

24+24+ 24+48

FR/NL/NO/PT/ES/UK DE 16-Oct-07

Pharma Gerke 31-Aug-07 Enbrel 25mg Powder and solvent for solution for injection for paediatric use

4+4+8+20+24


DE 16-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 48/153

Pharma Westen 14-May-07 Enbrel 25mg Solution for injection in a pre-filled syringe

4+8 swabs

AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 28-Jun-07


8+16 swabs


DE 28-Jun-07


24+48 swabs


DE 28-Jun-07

Pharma Westen 17-Sep-07 Enbrel 25mg Powder and solvent for solution for injection for paediatric use

4+4+8+20+24


DE 30-Nov-07

AxiCorp Pharma 24-Jan-07 Enbrel 50mg Solution for injection in a pre-filled syringe

4+8 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 10-Apr-07


4 AT/BE/FR/IT/GR/NO/PT/ ES/UK

DE 26-Jul-07


12 AT/BE/FR/IT/GR/NO/PT/ ES/UK

DE 26-Jul-07

CC Pharma 15-Jun-06 Enbrel 50mg Powder and solvent for solution for injection

12+12+ 24

GR DE 6-Jul-07

CC Pharma 27-Jan-06 Enbrel 50mg Powder and Solvent for solution for injection

4+4+8 GR DE 6-Jul-07

CC Pharma 27-Jan-06 Enbrel 50mg Powder and solvent for solution for injection

4+4+8 GR DE 10-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 49/153

Emra-Med 18-Jun-07 Enbrel 50mg Powder and solvent for solution for injection

4+4+4+4+8

GR DE 24-Sep-07

Kohlpharma 27-Mar-07 Enbrel 50mg Powder and solvent for solution for injection


DE 10-Apr-07

Kohlpharma 10-Apr-07 Enbrel 50mg Solution for injection in a pre-filled syringe


DE 30-Jul-07

Medartuum AB 26-Feb-07 Enbrel 50mg Solution for injection in a pre-filled syringe


SE 11-Jul-07

Medico Pharm 17-Jul-07 Enbrel 50mg Solution for injection in a pre-filled syringe


DE 8-Aug-07

Medico Pharm 24-May-07 Enbrel 50mg Solution for injection in a pre-filled syringe


DE 8-Aug-07

Orifarm AS 24-May-07 Enbrel 50mg Solution for injection in a pre-filled syringe

4+8 AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 20-Jul-07

Pharma Gerke 21-Nov-06 Enbrel 50mg Powder and solvent for solution for injection


DE 12-Jul-07

Pharma Gerke 27-Jan-06 Enbrel 50mg Powder and solvent for solution for injection


DE 12-Jul-07


4+8 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 28-Jun-07



DE 28-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 50/153

Emra-Med 18-Dec-06 Epivir 10mg/ml Oral solution 240ml SE DE 27-Jun-07

Pharma Gerke 30-Jul-07 Epivir 150mg Film-coated tablets


DE 10-Aug-07

CC Pharma 10-Apr-06 Epivir 300mg Film-coated tablets

30 FR/GR/NO/PT/ES/UK DE 5-Mar-07

Delphi BV 03-Jul-07 Epivir 300mg Film-coated tablets


NL 22-Aug-07

Emra-Med 04-Aug-06 Epivir 300mg Film-coated tablets

30 IT DE 1-Aug-07


13-Feb-07 Evista 60mg Film-coated tablets


UK/IE 15-May-07


13-Feb-07 Evista 60mg Film-coated tablets


UK/IE 15-May-07

BR Lewis 25-May-07 Evista 60mg Film-coated tablets

28 AT/BE/CY/DK/FI/FR/DE/GR/IE/IS/IT/LI/LU/NL/ NO/PT/ES/SE/UK

UK/IE/MT 7-Aug-07

PCO Ltd 14-Dec-06 Evista 60mg Film-coated tablets


UK/IE 23-May-07

Pharma Westen 22-Jan-07 Evista 60mg Film-coated tablets


DE 21-Sep-07

Pharma Westen 22-Jan-07 Evista 60mg Film-coated tablets


DE 21-Sep-07

SRL Pharmaceuticals

11-Oct-05 Evista 60mg Film-coated tablets


UK 22-Feb-07

Stephar (UK) Ltd 02-Nov-07 Evista 60mg Film-coated tablets

28 AT/BE/CY/FR/DE/GR/IE/IT/MT/NL/PT/ES

UK 6-Dec-07


08-Nov-06 Evista 60mg Film-coated tablets


UK 20-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 51/153

Orifarm AB 05-Mar-07 Evra 150/20µg Transdermal patches


SE 10-Apr-07

Orifarm AS 05-Mar-07 Evra 150/20µg Transdermal patches


DK 10-Apr-07

Orifarm OY 05-Mar-07 Evra 150/20µg Transdermal patches

9 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NO/PT/ES/SE/NL/UK

FI 10-Apr-07

Forfarm 24-Apr-06 Evra 150/20µg Transdermal patches

3 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PT/SI/SK/SE/UK

PL 28-Jun-07

G-Pharma 30-Jul-07 Exelon 1.5mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 15-Aug-07

Paranova AS 05-Mar-07 Exelon 1.5mg Hard capsules 112 AT/BE/FI/FR/DE/GR/IS/ IE/IT/NL/NO/PT/ES/SE/UK

DK 23-Apr-07

SRL Pharmaceuticals

11-May-06 Exelon 1.5mg Hard capsules 28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK 2-Mar-07

Stephar (UK) Ltd 02-Nov-07 Exelon 1.5mg Hard capsules 56 AT/BE/CY/FR/DE/GR/IE/IT/MT/NL/PT/ES

UK 7-Dec-07

Dowelhurst Ltd 18-Oct-07 Exelon 3.0mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 9-Nov-07

Fisher Farma 06-Dec-06 Exelon 3.0mg Hard capsules 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 25-Jan-07

G-Pharma 08-Feb-07 Exelon 3.0mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 10-May-07

Medartuum AB 12-Jan-07 Exelon 3.0mg Hard capsules 112 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 5-Sep-07

EMEA/311899/2008 © EMEA 2008 Page 52/153

Paranova AS 07-Mar-07 Exelon 3.0mg Hard capsules 112 AT/BE/FI/FR/DE/GR/IS/ IE/IT/NL/NO/PT/ES/SE/UK

DK 23-Apr-07

Paranova AS 08-May-07 Exelon 3.0mg Hard capsules 56 AT/BE/FI/FR/DE/GR/IS/ IE/IT/NL/NO/PT/ES/SE/UK

DK 11-Jun-07

SRL Pharmaceuticals


UK 2-Mar-07

Stephar (UK) Ltd 02-Nov-07 Exelon 3.0mg Hard capsules 56 AT/BE/CY/FR/DE/GR/IE/IT/MT/NL/PT/ES

UK 7-Dec-07

Euroregistratie BV 30-Aug-07 Exelon 4.5mg Hard capsules 56 AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 25-Sep-07


UK 15-Aug-07

SRL Pharmaceuticals


UK 2-Mar-07


10-Jan-07 Exelon 4.5mg Hard capsules 28 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 20-Apr-07

Colorama 28-Dec-06 Exelon 6.0mg Hard capsules 28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 29-Mar-07

Euroregistratie BV 30-Aug-07 Exelon 6.0mg Hard capsules 56 AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 25-Sep-07


UK 15-Aug-07

SRL Pharmaceuticals


UK 2-Mar-07


09-Jan-07 Exelon 6.0mg Hard capsules 28 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 20-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 53/153

BR Pharma 25-Apr-07 Exforge 10/160mg Film-coated tablets

14 AT/BE/DK/FI/FR/DE/GR/IS/IT/LI/LU/NL/NO/PT/ES/SE

UK/IE 11-Jun-07



UK/IE 11-Jun-07



UK/IE 11-Jun-07



UK/IE 11-Jun-07

Chemilines Ltd 09-Jul-07 Exforge 10/160mg Film-coated tablets


UK/IE 17-Sep-07



UK/IE 17-Sep-07



UK/IE 17-Sep-07

Dowelhurst Ltd 01-Nov-07 Exforge 10/160mg Film-coated tablets


UK 20-Dec-07

Euroregistratie BV 30-Aug-07 Exforge 10/160mg Film-coated tablets


NL 12-Sep-07


24-Sep-07 Exforge 10/160mg Film-coated tablets


UK 16-Oct-07

Top Pharma B.V. 20-Aug-07 Exforge 10/160mg Film-coated tablets


NL 6-Sep-07



UK/IE 17-Sep-07

EMEA/311899/2008 © EMEA 2008 Page 54/153



UK/IE 17-Sep-07



UK/IE 17-Sep-07



UK 20-Dec-07




UK 16-Oct-07



NL 6-Sep-07

Waymade 27-Apr-07 Exforge 5/160mg Film-coated tablets


UK 28-May-07



NL 12-Sep-07



UK 20-Dec-07



NL 12-Sep-07




UK 16-Oct-07



NL 6-Sep-07

Waymade 27-Apr-07 Exforge 5/80mg Film-coated tablets


UK 28-May-07


26-Mar-07 Faslodex 250 mg/5 ml Solution for injection in a pre-filled syringe


NL 17-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 55/153

Opal Healthcare Ltd 07-Dec-06 Faslodex 250 mg/5 ml Solution for injection


UK 16-Jul-07

Paranova AB 02-Jan-07 Ferriprox 500mg Film-coated tablets

100 AT/DE/GR/NL/ES/UK SE 2-Jul-07

Orifarm A/S 08-Feb-07 Forsteo 20 µg/80 µl Solution for injection in a pre-filled pen

1 pen AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 30-Mar-07

Orifarm AB 08-Feb-07 Forsteo 20 µg/80 µl Solution for injection in a pre-filled pen

1 pen AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LU/MT/NO/PT/ES/NL/UK

SE 10-May-07

BR Lewis 13-Dec-06 Fosavance 70 mg/70 µg Tablets 4 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/NL/ PT/ES/SE/UK

UK/IE/MT 2-Feb-07

BR Pharma 23-Dec-05 Fosavance 70 mg/70 µg Tablets 4 DE UK/IE 29-Jan-07

Dowelhurst Ltd 08-Sep-06 Fosavance 70 mg/70 µg Tablets 4 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/ES/SE

UK 20-Jul-07

Fisher Farma 16-Nov-06 Fosavance 70 mg/70 µg Tablets 4 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 23-Mar-07

G-Pharma 24-Aug-06 Fosavance 70 mg/70 µg Tablets 4 AT/BE/CZ/DK/EE/FI/FR/ DE/GR/HU/IS/IE/IT/LV/LT/LU/MT/NL/NO/PL/ PT/SK/SI/ES/SE

UK 15-Jan-07

Medartuum AB 22-Feb-07 Fosavance 70 mg/70 µg Tablets 12 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 15-Aug-07

Paranova AS 05-Feb-07 Fosavance 70 mg/70 µg Tablets 12 AT/BE/FI/FR/DE/GR/IT/NL/NO/ES/SE/UK

DK 22-May-07

Paranova AS 05-Feb-07 Fosavance 70 mg/70 µg Tablets 4 AT/BE/FI/FR/DE/GR/IT/NL/NO/ES/SE/UK

DK 1-Aug-07

Intercare 02-Mar-06 Fosavance 70 mg/70 µg Tablets 4 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK/IE 13-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 56/153

Dowelhurst Ltd 05-Nov-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution


UK 6-Dec-07

Euroregistratie BV 14-Nov-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution

3ml AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 10-Dec-07

Fisher Farma 02-Jul-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution


NL 27-Jul-07

Intercare 10-Apr-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution

3ml AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

IE/UK 24-Apr-07

Kohlpharma 19-Feb-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution

3ml AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 11-Apr-07

Kohlpharma 19-Feb-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution

3x3ml AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 11-Apr-07

Mediport 15-Jun-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution


UK 15-Aug-07


22-Jun-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution


UK 24-Sep-07

Waymade 15-Feb-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution

3ml AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 11-May-07


3-Jul-07 Ganfort 300µg/ml + 5mg/ml

Eye drops solution

1x3ml AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 25-Jul-07

Emra-Med 19-Oct-06 Glivec 100mg Film-coated tablets

60 FR/ES DE 27-Mar-07

Kohlpharma 13-Jul-07 Glivec 100mg Film-coated tablets


DE 14-Aug-07

Orifarm AB 26-Apr-07 Glivec 100mg Film-coated tablets

60 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/NL/PT/ES/UK

SE 24-May-07

Pharma Westen 28-Feb-07 Glivec 100mg Film-coated tablets


DE 17-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 57/153

CC Pharma 04-Oct-06 Glivec 400mg Film-coated tablets


DE 19-Feb-07

Medartuum AB 22-Aug-07 Gonal-f 900 IU/1.5 ml Solution for injection in a pre-filled pen


SE 21-Sep-07

Omnia Läkemedel AB

02-Jul-07 Gonal-f 900 IU/1.5 ml Solution for injection in a pre-filled pen

1+14 BE/FR/DE/GR/IE/IT/NL/ PT/ES/UK

SE 30-Aug-07

Paranova AS 28-Mar-07 Gonal-f 900 IU/1.5 ml Solution for injection in a pre-filled pen

1+14 FR DK 20-Apr-07

A.C.A. Muller 10-Aug-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe

1 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DE 20-Nov-07

AxiCorp Pharma 24-Jan-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe


DE 7-Feb-07

AxiCorp Pharma 24-Jan-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe


DE 7-Feb-07

Emra-Med 26-Mar-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe

1 ES DE 2-Jul-07

Emra-Med 26-Mar-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe

10 ES DE 2-Jul-07

Emra-Med 29-Dec-06 HBVAXPRO 10µg/ml Suspension for injection in a vial

1 PL DE 7-Aug-07

Emra-Med 29-Dec-06 HBVAXPRO 10µg/ml Suspension for injection in a vial

10 PL DE 7-Aug-07

Eurim-Pharm 20-Dec-06 HBVAXPRO 10µg/ml Suspension for injection in a pre-fille syringe

1 GR/FR DE 30-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 58/153

Eurim-Pharm 20-Dec-06 HBVAXPRO 10µg/ml Suspension for injection in a pre-fille syringe

10 GR/FR DE 30-Jan-07

Euroregistratie BV 18-Apr-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe

1+2 needles

AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 14-Jun-07

Fisher Farma 01-Dec-06 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe


NL 2-Jul-07

Kohlpharma 15-Jan-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe

1 AT/BE/FR/IE/IT/NL/NO/PT/ES/SE/UK

DE 20-Feb-07

Kohlpharma 15-Jan-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe


DE 20-Feb-07


26-Mar-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe


NL 25-Apr-07

Veron Pharma 20-Nov-06 HBVAXPRO 10µg/ml Suspension for injection in a vial

1 AT/BE/FR/GR/IT/NL/PT/ ES

DE 22-Feb-07

Veron Pharma 16-Mar-07 HBVAXPRO 10µg/ml Suspension for injection in a pre-filled syringe


DE 17-Apr-07


26-Mar-07 HBVAXPRO 40µg/ml Suspension for injection in a vial


NL 25-Apr-07

Veron Pharma 20-Nov-06 HBVAXPRO 40µg/ml Suspension for injection in a vial


DE 22-Feb-07

AxiCorp Pharma 11-May-07 HBVAXPRO 5 µg/0.5 ml Suspension for injection in a pre-filled syringe

1+2 needles

AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 7-Jun-07

Emra-Med 14-May-07 HBVAXPRO 5µg/0.5ml Suspension for injection in a pre-filled syringe

1+2 needles

AT DE 29-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 59/153

Eurim-Pharm 20-Dec-06 HBVAXPRO 5 µg/0.5 ml Suspension for injection in a pre-fille syringe

1 FR DE 30-Jan-07

Eurim-Pharm 20-Dec-06 HBVAXPRO 5 µg/0.5 ml Suspension for injection in a pre-fille syringe

10 FR DE 30-Jan-07

Kohlpharma 17-Jan-07 HBVAXPRO 5 µg/0.5 ml Suspension for injection in a pre-filled syringe


DE 22-Mar-07

Kohlpharma 17-Jan-07 HBVAXPRO 5 µg/0.5 ml Suspension for injection in a pre-filled syringe


DE 22-Mar-07

CC Pharma 04-May-06 Helixate 1.000IU Solution for injection

1 vial + 1 vial + 1 set of adm. devices

NO DE 9-Aug-07

Paranova AB 16-Apr-07 Hepsera 10mg Tablets 30 BE/FR/GR/IT/NL/UK SE 21-May-07

Haemato-pharm Holding AG

29-Jan-07 Herceptin 150mg Powder for concentrate for solution for infusion

1 FR/UK DE 3-Jul-07

Medartuum AB 31-Aug-07 Herceptin 150mg Powder for concentrate for solution for infusion


SE 21-Nov-07

Orifarm AB 26-Mar-07 Herceptin 150mg Powder for concentrate for solution for infusion


SE 4-Apr-07

Orifarm OY 26-Apr-07 Herceptin 150mg Powder for concentrate for solution for infusion


FI 11-May-07

EMEA/311899/2008 © EMEA 2008 Page 60/153

Pharma Gerke 29-Aug-07 Herceptin 150mg Powder for concentrate for solution for infusion

1 AT/BE/FR/GR/IT/LT/NL/ NO/PT/ES/UK

DE 6-Sep-07

BR Lewis 15-Jun-07 Humalog 100IU/ml Solution for injection in a cartridge

5x3ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/NL/ NO/PT/ES/SE/UK

UK/IE/MT 19-Jul-07

BR Lewis 16-May-07 Humalog 100IU/ml Solution for injection in a vial


UK/IE/MT 2-Aug-07

Ginova 23-Mar-07 Humalog 100IU/ml Solution for injection in a cartridge


UK 17-Jul-07

Ginova 21-Nov-06 Humalog 100IU/ml Solution for injection in a vial


UK 19-Jul-07


23-Mar-07 Humalog 100IU/ml Solution for injection in a cartridge


UK 29-May-07


24-Apr-07 Humalog 100IU/ml Solution for injection in a cartridge


UK 31-Aug-07


24-Apr-07 Humalog 100IU/ml Solution for injection in a vial


UK 3-Dec-07

B&S Healthcare 16-Aug-06 Humalog 100IU/ml Solution for injection in a vial

1x10ml AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 8-Feb-07

B&S Healthcare 16-Aug-06 Humalog 100IU/ml Solution for injection in a cartridge


UK/IE 8-Feb-07

Intercare 13-Feb-07 Humalog 100IU/ml Solution for injection in a cartridge

5x3ml AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 10-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 61/153

Lexon 10-Jan-07 Humalog 100IU/ml Solution for injection in a vial

1x10ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 31-Jan-07


05-Jul-06 Humalog Humaject

100IU/ml Solution for injection in a pre-filled pen

5 pens AT/BE/FR/DE/GR/IE/IT/ NL/PT/ES

UK 19-Feb-07

Colorama 31-Mar-03 Humalog Mix 25


5x3ml

AT/BE/DK/FI/FR/DE/GR/IT/LU/NL/PT/ES/SE

UK/IE 5-Nov-07

Colorama 28-Dec-06 Humalog Mix 25


5x3ml AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 5-Nov-07

Ginova 22-Mar-07 Humalog Mix 25



UK 4-May-07


24-Apr-07 Humalog Mix 25



UK 3-Dec-07

B&S Healthcare 16-Aug-06 Humalog Mix 25



UK/IE 8-Feb-07

Intercare 15-Feb-07 Humalog Mix 25



UK/IE 30-May-07

BR Lewis 15-Jun-07 Humalog Mix 25



UK/IE/MT 19-Jul-07

Colorama 31-Mar-03 Humalog Mix 25 Pen

100IU/ml Suspension for injection in a pre-filled pen

5 pens AT/BE/DK/FI/FR/DE/GR/IT/LU/NL/PT/ES/SE

UK/IE 5-Nov-07

Ginova 23-Mar-07 Humalog Mix 25 Pen


5 pens AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 4-May-07

Testerworld Ltd 28-Jun-06 Humalog Mix 25 Pen


5 pens AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 18-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 62/153

B&S Healthcare 16-Aug-06 Humalog Mix 25 Pen


5 pens AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 8-Feb-07

BR Lewis 21-May-07 Humalog Mix 25 Pen


5 pens AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/NL/ NO/PT/ES/SE/UK

UK/IE/MT 27-Jun-07

Intercare 05-Jan-07 Humalog Mix 25 Pen



UK/IE 2-Apr-07


25-Apr-07 Humalog Mix 25 Pen


5 pens AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 18-Oct-07

Chemilines Ltd 23-Aug-06 Humalog Mix 50

100IU/ml suspension for injection in a cartridge


UK 10-Jan-07

Intercare 15-Feb-07 Humalog Mix 50



UK/IE 30-May-07

Colorama 31-Mar-03 Humalog Mix 50 Pen


5 pens AT/BE/DK/FI/FR/DE/GR/IT/LU/NL/PT/ES/SE

UK/IE 5-Nov-07

Ginova 23-Mar-07 Humalog Mix 50 Pen


5 pens l AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 4-May-07


22-Mar-07 Humalog Mix 50 Pen


5 pens AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 29-May-07

Testerworld Ltd 28-Jun-06 Humalog Mix 50 Pen



UK 18-Jul-07

Intercare 05-Jan-07 Humalog Mix 50 Pen



UK/IE 2-Apr-07


25-Apr-07 Humalog Mix 50 Pen



UK 18-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 63/153

B&S Healthcare 16-Aug-06 Humalog Pen 100IU/ml Solution for injection in a pre-filled pen

5 pens AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 8-Feb-07

Colorama 28-Dec-06 Humalog Pen 100IU/ml Solution for injection in a pre-filled pen

5 pens AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 10-Oct-07

Pharma Westen 21-Jun-06 Humalog Pen 100IU/ml Solution for injection in a pre-filled pen

5 pens AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 20-Aug-07

Pharma Westen 21-Jun-06 Humalog Pen 100IU/ml Solution for injection in a pre-filled pen

10 pens AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 20-Aug-07


24-Apr-07 Humalog Pen 100IU/ml Solution for injection in a pre-filled pen


UK 3-Dec-07

CC Pharma 18-Sep-07 Humira 40mg Solution for injection in a pre-filled pen

2+2 AT/BE/FR/GR/IT/NO/ES/ PT/UK

DE 5-Nov-07

CC Pharma 18-Sep-07 Humira 40mg Solution for injection in a pre-filled pen

6+6 AT/BE/FR/GR/IT/NO/ES/ PT/UK

DE 5-Nov-07

Pharma Gerke 28-Nov-05 Humira 40mg Solution for injection in a pre-filled syringe

2+2 BE/FR/GR/NO DE 31-Jul-07

Pharma Gerke 28-Nov-05 Humira 40mg Solution for injection in a pre-filled syringe

4+4 BE/FR/GR/NO DE 31-Jul-07

CC Pharma 21-May-07 Hycamtin 4mg Powder for solution for infusion in a vial

5 GR DE 6-Jun-07


29-Jan-07 Hycamtin 4mg Powder for solution for infusion

5 GR DE 25-Sep-07

AxiCorp Pharma 24-Nov-06 Infanrix Hexa 0.5ml Powder and suspension for suspension for injection


DE 22-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 64/153

Eurim-Pharm 20-Nov-06 Infanrix Hexa 0.5ml Powder and suspension for suspension for injection

1 GR DE 5-Feb-07


10 GR DE 5-Feb-07


20 GR DE 5-Feb-07


50 GR DE 5-Feb-07

Emra-Med 19-Mar-07 Infanrix Hexa 0.5ml Powder and suspension for suspension for injection

1 vial + 1 syringe

BE DE 3-Aug-07

Pharma Westen 20-Jul-07 Infanrix Hexa 0.5ml Powder and suspension for suspension for injection

1+1+2 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 30-Nov-07

Pharma Westen 20-Jul-07 Infanrix Hexa 0.5ml Powder and suspension for suspension for injection

10+10+ 20


DE 30-Nov-07

Delphi BV 21-Jun-07 Insulatard Flexpen


5 pens AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 12-Jul-07

Waymade 02-May-07 Insulatard Penfill

100IU/ml Suspension for injection in cartridge

5x3ml AT/BE/FR/DE/GR/IT/NL/NO/PT/ES

UK 14-Jun-07

Emra-Med 28-Sep-05 Insuman Comb 25


5x3ml UK DE 7-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 65/153

Pharma Westen 29-May-07 Insuman Comb 25

100IU/ml Suspension for injection in cartridge

5x3ml AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 20-Sep-07

B&S Healthcare 05-Jul-07 Intrinsa 300 µg/24 h Transdermal patches


UK/IE 14-Dec-07

Stephar (UK) Ltd 28-Jun-07 Intrinsa 300 µg/24 h Transdermal patches

8 AT/BE/CY/FR/DE/GR/IE/IT/MT/NL/PT/ES

UK 1-Aug-07

Emra-Med 17-Aug-06 IntronA 18 Million IU Solution for injection in a pre-filled pen

2 pens ES DE 20-Jul-07



Paranova AB 04-Jun-07 IntronA 18 Million IU Solution for injection in a pre-filled pen

1+12+12 BE/FR/GR/IE/IT/ES SE 20-Jul-07






2 pens ES DE 17-Oct-07


8 pens ES DE 17-Oct-07


15-Oct-07 Invega 9mg Prolonged-release tablets


UK/IE 9-Nov-07

A.C.A. Muller 21-Jun-07 Invirase 500mg Film-coated tablets

120 UK DE 11-Oct-07

Medico Pharm 27-Feb-06 Invirase 500mg Film-coated tablets


DE 20-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 66/153

A.C.A. Muller 19-Mar-07 Iscover 75mg Film-coated tablets

28 ES DE 18-Jul-07

A.C.A. Muller 19-Mar-07 Iscover 75mg Film-coated tablets

100 ES DE 18-Jul-07

G-Pharma 15-Nov-06 Iscover 75mg Film-coated tablets


UK 10-Aug-07

N.G. Ltd 24-Nov-06 Iscover 75mg Film-coated tablets


UK 15-May-07

Paranova AS 21-May-07 Iscover 75mg Film-coated tablets

84 DE/GR/ES DK 25-Jun-07

Pharma Westen 22-May-06 Iscover 75mg Film-coated tablets


DE 14-Feb-07

Pharma Westen 22-May-06 Iscover 75mg Film-coated tablets


DE 14-Feb-07

SinGad Pharma ApS

21-Jun-07 Iscover 75mg Film-coated tablets

84 ES DK 21-Aug-07


09-Jan-07 Iscover 75mg Film-coated tablets


UK 16-May-07

Dowelhurst Ltd 15-Jun-07 Januvia 100mg Film-coated tablets


UK 11-Jul-07


08-Oct-07 Januvia 100mg Film-coated tablets


UK 13-Dec-07

Emra-Med 09-Feb-07 Kaletra 133.3/33.3mg Soft capsules 180 BE/NL DE 20-Jul-07

Paranova AB 21-Feb-07 Kaletra 133.3/33.3mg Soft capsules 180 AT/BE/FI/FR/DE/NL/ES/ UK

SE 12-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 67/153

Paranova OY 31-May-07 Kaletra 133.3/33.3mg Soft capsules 180 BE/NL FI 10-Aug-07

Pharma Westen 06-Nov-06 Kaletra 133.3/33.3mg Soft capsules 180 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 3-Jul-07

Emra-Med 25-May-07 Kaletra 200/50mg Film-coated tablets

120 AT DE 17-Jul-07

EU-Pharma B.V. 08-Aug-07 Kaletra 200/50mg Film-coated tablets

120 AT/BE/FR/DE/GR/HU/IT/PT/ES/UK

NL 15-Aug-07

Euroregistratie BV 18-Apr-07 Kaletra 200/50mg Film-coated tablets


NL 14-Jun-07

Kohlpharma 27-Nov-06 Kaletra 200/50mg Film-coated tablets


DE 2-Jul-07

Medico Pharm 17-Jan-07 Kaletra 200/50mg Film-coated tablets

120 (blister)


DE 25-Jul-07

Medico Pharm 23-Oct-06 Kaletra 200/50mg Film-coated tablets

120 (bottle)


DE 25-Jul-07

Pharma Gerke 07-Nov-06 Kaletra 200/50mg Film-coated tablets


DE 23-Oct-07

Pharma Westen 10-Nov-06 Kaletra 200/50mg Film-coated tablets


DE 3-Jul-07

Pharma Westen 26-Jun-06 Kaletra 400/100mg Oral solution 5x5ml AT/BE/CY/CZ/DK/EE/ GR/ES/FI/FR/HU/IE/IS/ IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE/UK

DE 15-Mar-07

CC Pharma 10-Nov-06 Kaletra 80/20mg Oral solution 5 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 19-Jun-07

Emra-Med 23-Jan-07 Kaletra 80/20mg Oral solution 5 NL DE 21-May-07

B&S Healthcare 30-Nov-06 Karvea 150mg Film-coated tablets


UK/IE 15-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 68/153

Colorama 26-Apr-07 Karvea 150mg Film-coated tablets


UK 3-Aug-07

G-Pharma 14-Jun-07 Karvea 150mg Film-coated tablets


UK 27-Jul-07

Qdoxx Pharma AB 26-Jun-06 Karvea 150mg Tablets 98 GR SE 18-Sep-07

Waymade 13-Sep-06 Karvea 150mg Film-coated tablets


UK 9-Jan-07

B&S Healthcare 30-Nov-06 Karvea 300mg Film-coated tablets


UK/IE 15-Feb-07

Colorama 26-Apr-07 Karvea 300mg Film-coated tablets


UK 3-Aug-07



UK 27-Jul-07



UK 9-Jan-07



UK 27-Jul-07


13-Jun-07 Karvea 75mg Tablets 28 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PL/PT/SK/SI/ES/SE

UK 27-Jul-07



UK 9-Jan-07

Chemilines Ltd 14-Feb-07 Karvezide 150/12.5mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 24-May-07

G-Pharma 14-Jun-07 Karvezide 150/12.5mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 30-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 69/153

Pharma Westen 26-Feb-07 Karvezide 150/12.5mg Tablets 28 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 26-Sep-07


DE 26-Sep-07


DE 26-Sep-07

Qdoxx Pharma AB 26-Jun-06 Karvezide 150/12.5mg Tablets 98 GR SE 24-Jan-07

Chemilines Ltd 14-Feb-07 Karvezide 300/12.5mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 24-May-07

G-Pharma 14-Jun-07 Karvezide 300/12.5mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 30-Jul-07

Paranova AS 14-May-07 Karvezide 300/12.5mg Film-coated tablets

98 DE/GR/IT/PT/ES/SE DK 20-Aug-07


DE 26-Sep-07


DE 26-Sep-07


DE 26-Sep-07

Qdoxx Pharma AB 26-Jun-06 Karvezide 300/12.5mg Tablets 98 GR SE 24-Jan-07

Kohlpharma 15-Oct-07 Karvezide 300/25mg Film-coated tablets


DE 9-Nov-07



DE 9-Nov-07



DE 9-Nov-07

EMEA/311899/2008 © EMEA 2008 Page 70/153

BR Lewis 17-Jul-07 Keppra 1000mg Film-coated tablets

30 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/NL/ PT/ES/SE/UK

UK/IE/MT 3-Sep-07

CC Pharma 23-Apr-07 Keppra 1000mg Film-coated tablets


DE 22-Oct-07



DE 22-Oct-07



DE 22-Oct-07

Dowelhurst Ltd 19-Sep-07 Keppra 1000mg Film-coated tablets


UK 5-Nov-07

Interport 22-Feb-07 Keppra 1000mg Film-coated tablets

30 BE/FR/GR/IT/NL/PT/ES UK 2-Aug-07

Mediport 24-Apr-07 Keppra 1000mg Film-coated tablets


UK 11-Jul-07

N.G. Ltd 03-May-05 Keppra 1000mg Film-coated tablets


UK 19-Apr-07


12-Feb-07 Keppra 1000mg Film-coated tablets


UK 17-Oct-07


11-Jan-07 Keppra 1000mg Film-coated tablets


UK 27-Jul-07

Waymade 30-Nov-06 Keppra 1000mg Film-coated tablets


UK 20-Jul-07

Ginova 07-Nov-06 Keppra 1000mg Film-coated tablets


UK 12-Feb-07

G-Pharma 08-Nov-06 Keppra 1000mg Film-coated tablets


UK 18-Apr-07

Pharmachim AB 28-Mar-07 Keppra 1000mg Film-coated tablets

30 AT/BE/FR/DE/GR/IT/NL/PT/ES/UK

SE 18-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 71/153

Pharmachim AB 12-Mar-07 Keppra 1000mg Film-coated tablets


SE 18-Apr-07

Chemilines Ltd 20-Nov-06 Keppra 100mg/ml Oral solution 300ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 2-Feb-07

Emra-Med 17-Aug-06 Keppra 100mg/ml Oral solution 300ml ES DE 26-Jul-07

Euroregistratie BV 14-Nov-07 Keppra 100mg/ml Oral solution 300ml AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 18-Dec-07

Fisher Farma 02-Jul-07 Keppra 100mg/ml Oral solution 1+1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 30-Jul-07

G-Pharma 14-Nov-06 Keppra 100mg/ml Oral solution 300ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 16-Apr-07

Intercare 08-Nov-06 Keppra 100mg/ml Oral solution 300ml AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 23-Apr-07

Lexon 14-Jun-07 Keppra 100mg/ml Oral solution 300ml AT/BE/CY/DK/FI/FR/DE/IS/IE/IT/LT/LI/LU/MT/ NL/NO/PT/ES/SE

UK 26-Sep-07

Medartuum AB 15-Sep-06 Keppra 100mg/ml Oral solution 300ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 16-Jan-07

Mediport 08-Jun-07 Keppra 100mg/ml Oral solution 300ml AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 17-Jul-07

N.G. Ltd 15-Dec-06 Keppra 100mg/ml Oral soution 300ml AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PO/PT/SK/SI/ES/SE

UK 12-Nov-07

Orifarm A/S 15-Feb-07 Keppra 100mg/ml Oral solution 300ml AT/BE/CY/FI/FR/DE/GR/IE/IT/LI/MT/NO/PT/ES/SE/NL/UK

DK 8-Mar-07

Orifarm AB 15-Feb-07 Keppra 100mg/ml Oral solution 300ml AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LI/MT/NO/PT/ES/NL/UK

SE 8-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 72/153

Pharma Westen 04-May-06 Keppra 100mg/ml Oral solution 300ml AT/BE/CY/CZ/EE/DK/FI/FR/GR/HU/IS/IE/IT/LT/LV/LU/MT/NL/NO/PL/ PT/SK/ES/SI/SE/UK

DE 20-Mar-07


22-Nov-06 Keppra 100mg/ml Oral solution 150ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 29-May-07

Colorama 28-Dec-06 Keppra 250mg Film-coated tablets


UK 12-Jul-07

Colorama 10-Aug-07 Keppra 250mg Film-coated tablets


UK 20-Nov-07

Ginova 15-Jan-07 Keppra 250mg Film-coated tablets


UK 18-Apr-07

G-Pharma 02-Jun-06 Keppra 250mg Film-coated tablets


UK 17-Apr-07

G-Pharma 27-Sep-06 Keppra 250mg Film-coated tablets


UK 17-Apr-07

Munro Wholesale Ltd

13-Dec-06 Keppra 250mg Film-coated tablets


UK 22-Jan-07



UK 19-Apr-07

Orifarm A/S 24-Nov-05 Keppra 250mg Film coated tablets

100 FR DK 8-Jan-07

Paranova AS 11-May-07 Keppra 250mg Film-coated tablets

100 BE/FI/FR/DE/GR/IE/NL/ NO/PT/ES/SE/UK

DK 1-Aug-07

Pharma Westen 03-May-06 Keppra 250mg Film-coated tablets

50 AT/BE/CY/CZ/EE/DK/FI/FR/GR/HU/IS/IE/IT/LT/LV/LU/MT/NL/NO/PL/ PT/SK/ES/SI/SE/UK

DE 9-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 73/153

Polyfarma Ltd 27-Jan-05 Keppra 250mg Film-coated tablets


UK/IE 13-Sep-07

SRL Pharmaceuticals

21-Dec-06 Keppra 250mg Film-coated tablets


UK 7-Aug-07


29-Mar-07 Keppra 500 mg Film-coated tablets

100 AT/BE/CY/DK/FR/DE/ GR/IE/IT/NL/NO/PT/ES

UK 17-Oct-07



DE 22-Oct-07



DE 22-Oct-07



DE 22-Oct-07

Dowelhurst Ltd 12-Nov-07 Keppra 500mg Film-coated tablets


UK 6-Dec-07

Emra-Med 06-Sep-06 Keppra 500mg Film-coated tablets

50 ES DE 6-Sep-07

Emra-Med 06-Sep-06 Keppra 500mg Film-coated tablets

100 ES DE 6-Sep-07

Ginova 20-Oct-06 Keppra 500mg Film-coated tablets


UK 12-Feb-07

G-Pharma 20-Dec-06 Keppra 500mg Film-coated tablets


UK 26-Jan-07

Mediport 24-Apr-07 Keppra 500mg Film-coated tablets


UK 11-Jul-07



UK 19-Apr-07

Waymade 19-Jul-07 Keppra 500mg Film-coated tablets


UK 7-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 74/153


19-Jul-06 Keppra 500mg Film-coated tablets

60 AT/BE/CY/FI/FR/DE/GR/IE/IT/NL/PT/ES

UK 24-Jul-07


12-Jul-06 Keppra 500mg Film-coated tablets

30 AT/BE/CY/FI/FR/DE/GR/IE/IT/NL/PT/ES

UK 31-Jul-07

Mediwin Limited 16-Oct-07 Ketek 400mg Film-coated tablets

10 AT/BE/DK/FI/DE/GR/IE/IT/LU/NL/PT/ES/SE/UK

FR 24-Oct-07

Orifarm OY 16-Feb-07 Ketek 400mg Film-coated tablets

10 AT/BE/CY/DK/FR/DE/ GR/IE/IT/NO/PT/ES/NL/UK

FI 4-Apr-07



FI 4-Apr-07



FI 4-Apr-07

Pharmachim AB 15-Feb-07 Ketek 400mg Film-coated tablets

10 BE/FR/DE/GR/IT SE 29-Mar-07

Emra-Med 10-Nov-06 Kinzalmono 20mg Tablets 28 NL DE 9-Jul-07

BR Pharma 27-Apr-07 Kinzalmono 40mg Tablets 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IT/LI/NL/NO/PT/ES/SE

UK/IE 13-Dec-07


UK/IE 13-Dec-07

G-Pharma 12-Feb-07 Kinzalmono 40mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 26-Apr-07


31-Oct-06 Kinzalmono 40mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 8-Jun-07


UK/IE 13-Dec-07

EMEA/311899/2008 © EMEA 2008 Page 75/153


UK/IE 13-Dec-07

G-Pharma 12-Feb-07 Kinzalmono 80mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 26-Apr-07

AxiCorp Pharma 07-Dec-06 Kivexa 600/300mg Film-coated tablets


DE 9-May-07

Delphi BV 27-Dec-06 Kivexa 600/300mg Film-coated tablets


NL 5-Mar-07

Paranova AB 02-Apr-07 Kivexa 600/300mg Film-coated tablets

30 AT/BE/FR/DE/NL/NO/ ES/UK

SE 8-May-07

B&S Healthcare 04-Oct-06 Lantus 100IU/ml Solution for injection in a cartridge


UK/IE 8-Jan-07

B&S Healthcare 20-Dec-06 Lantus 100IU/ml Solution for injection in a vial


UK/IE 6-Nov-07

Delphi BV 06-Jul-07 Lantus 100IU/ml Solution for injection in a pre-filled pen


NL 13-Sep-07

Delphi BV 06-Jul-07 Lantus 100IU/ml Solution for injection in a cartridge

5x3ml AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 13-Sep-07

Intercare 25-May-07 Lantus 100IU/ml Solution for injection in a pre-filled pen


UK/IE 23-Jul-07

Intercare 02-May-07 Lantus 100IU/ml Solution for injection in a vial


UK/IE 25-Jul-07


08-Mar-07 Lantus 100IU/ml Solution for injection in a pre-filled pen


UK 14-Nov-07

EMEA/311899/2008 © EMEA 2008 Page 76/153


08-Mar-07 Lantus 100IU/ml Solution for injection in a cartridge (OptiClick)


UK 14-Nov-07


07-Mar-07 Lantus 100IU/ml Solution for injection in a cartridge


UK 14-Nov-07


07-Mar-07 Lantus 100IU/ml Solution for injection in a vial


UK 14-Nov-07

Orifarm AB 19-Sep-07 Lantus Opticlick

100IU/ml Solution for injection in a cartridge

5x3ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 4-Dec-07

Euroregistratie BV 31-Jan-07 Lantus OptiSet



NL 17-Jul-07

Delphi BV 16-Jul-07 Levemir Flexpen



NL 27-Sep-07

Paranova AS 02-Apr-07 Levemir Flexpen


5 pens BE/FI/FR/DE/IT/NO/ES/ SE

DK 20-Apr-07

B&S Healthcare 14-Nov-06 Levitra 10mg Film-coated tablets


UK/IE 4-Jan-07



UK/IE 4-Jan-07



UK/IE 4-Jan-07

CC Pharma 02-May-07 Levitra 10mg Film-coated tablets


DE 21-May-07

CC Pharma 20-Apr-07 Levitra 10mg Film-coated tablets


DE 8-May-07

Chemilines Ltd 08-Feb-07 Levitra 10mg Film-coated tablets

2 AT/BE/CY/CZ/DK/FI/FR/DE/GR/HU/IS/IE/IT/LI/ LU/MT/NL/NO/PL/SK/SI/PT/ES/SE

UK 26-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 77/153

Chemilines Ltd 30-Nov-06 Levitra 10mg Film-coated tablets


UK 26-Apr-07

G-Pharma 05-Mar-07 Levitra 10mg Film-coated tablets


UK 26-Apr-07

Intercare 19-Jul-07 Levitra 10mg Film-coated tablets


UK/IE 8-Aug-07

Intercare 06-Sep-07 Levitra 10mg Film-coated tablets


UK/IE 19-Oct-07

Interport 23-Feb-07 Levitra 10mg Film-coated tablets

4 DE/PT UK 28-Mar-07

Lexon 16-Jul-07 Levitra 10mg Film-coated tablets

4 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 8-Aug-07

Mediport 15-Jun-07 Levitra 10mg Film-coated tablets


UK 5-Jul-07

Orifarm AS 15-Mar-07 Levitra 10mg Film-coated tablets

4 AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/MT/NL/NO/PT/ES/SE/UK

DK 19-Jul-07



DK 19-Jul-07

Orifarm OY 15-Mar-07 Levitra 10mg Film-coated tablets

4 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/MT/NL/NO/PT/ES/SE/UK

FI 19-Jul-07



FI 19-Jul-07



FI 19-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 78/153

Paranova OY 21-Jun-07 Levitra 10mg Film-coated tablets

4 GR/UK FI 12-Jul-07





Pharma Westen 20-Sep-07 Levitra 10mg Film-coated tablets


DE 16-Oct-07


15-Feb-07 Levitra 10mg Film-coated tablets


UK 8-May-07



UK/IE 4-Jan-07



DE 8-May-07



DE 8-May-07



UK 26-Apr-07



UK 26-Apr-07

Intercare 19-Jul-07 Levitra 20mg Film-coated tablets


UK/IE 8-Aug-07

Intercare 06-Sep-07 Levitra 20mg Film-coated tablets


UK/IE 19-Oct-07



UK 5-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 79/153



DK 19-Jul-07



DK 19-Jul-07



FI 19-Jul-07



FI 19-Jul-07



FI 19-Jul-07

Paranova AB 16-May-07 Levitra 20mg Film-coated tablets

4 AT/FI/FR/GR/IT/PT/UK SE 14-Jun-07

Paranova AB 16-May-07 Levitra 20mg Film-coated tablets

12 AT/FI/FR/GR/IT/PT/UK SE 14-Jun-07


15-Feb-07 Levitra 20mg Film-coated tablets


UK 8-May-07



UK/IE 4-Jan-07



UK 5-Jul-07

Intercare 17-Nov-06 Lumigan 0.3mg/ml Eye drops, solution

3ml AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 6-Feb-07


12-Mar-07 Lumigan 0.3mg/ml Eye drops solution


UK/IE 21-Sep-07

BR Lewis 25-Jul-07 Lumigan 0.3mg/ml Eye drops solution


UK/IE/MT 7-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 80/153

Colorama 02-Jan-07 Lumigan 0.3mg/ml Eye drops solution

1x3ml AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 25-Apr-07

Fisher Farma 30-Jul-07 Lumigan 0.3mg/ml Eye drops solution


NL 14-Aug-07

G-Pharma 26-Jul-07 Lumigan 0.3mg/ml Eye drops solution


UK 10-Aug-07

Kohlpharma 19-Feb-07 Lumigan 0.3mg/ml Eye drops solution


DE 23-May-07

Kohlpharma 19-Feb-07 Lumigan 0.3mg/ml Eye drops solution


DE 23-May-07

Lexon 05-Jun-07 Lumigan 0.3mg/ml Eye drops solution


UK 18-Jul-07

Mediport 22-May-07 Lumigan 0.3mg/ml Eye drops solution

1x3ml AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 1-Aug-07


29-Mar-07 Lumigan 0.3mg/ml Eye drops solution


UK 14-Aug-07


15-Feb-07 Lumigan 0.3mg/ml Eye drops solution


UK 10-May-07

Chemilines Ltd 29-Oct-07 Lyrica 100mg Hard capsules 21 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/PL/ES/SE

UK 10-Dec-07

Colorama 13-Aug-07 Lyrica 100mg Hard capsules 84 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 19-Nov-07

Dowelhurst Ltd 10-Jul-07 Lyrica 100mg Hard capsules 84 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LV/LI/ LU/MT/NL/NO/PL/PT/SI/SK/ES/SE

UK 7-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 81/153

Lexon 05-Jul-07 Lyrica 100mg Hard capsules 84 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 18-Oct-07

Paranova AB 23-Mar-07 Lyrica 100mg Hard capsules 84 AT/FR/DE/IT/PT/UK SE 10-Apr-07

PCO Ltd 01-Dec-06 Lyrica 100mg Hard capsules 84 AT/BE/CY/DK/FI/FR/DE/GR/IT/LU/MT/NL/PT/ ES/SE/UK

UK/IE 27-Mar-07


10-May-07 Lyrica 100mg Hard capsules 21 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 28-Jun-07


10-Apr-07 Lyrica 100mg Hard capsules 84 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/PT/ES/SE

UK 6-Jun-07


06-Jun-07 Lyrica 150mg Hard capsules 56 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE/UK

UK/IE 23-Oct-07


06-Jun-07 Lyrica 150mg Hard capsules 100x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE/UK

UK/IE 23-Oct-07

B&S Healthcare 05-Dec-06 Lyrica 150mg Hard capsules 100x1 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 30-Jan-07

Chemilines Ltd 17-Jan-07 Lyrica 150mg Hard capsules 14 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/PL/ES/SE

UK 14-May-07

Colorama 27-Nov-06 Lyrica 150mg Hard capsules 56 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 19-Mar-07

Colorama 19-Jul-07 Lyrica 150mg Hard capsules 100x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 19-Nov-07

Colorama 19-Jun-07 Lyrica 150mg Hard capsules 14 AT/BE/DK/FI/FR/DE/GR/IS/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 19-Nov-07

Dowelhurst Ltd 09-Mar-06 Lyrica 150mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 9-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 82/153

Dowelhurst Ltd 03-Apr-07 Lyrica 150mg Hard capsules 100x1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 27-Apr-07

Euroregistratie BV 25-Oct-06 Lyrica 150mg Hard capsules 14 AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 6-Mar-07

G-Pharma 30-May-06 Lyrica 150mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 13-Mar-07

Lexon 14-Jun-07 Lyrica 150mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 26-Jun-07

Mediport 18-Apr-07 Lyrica 150mg Hard capsules 14 AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 4-May-07


UK 4-May-07

Orifarm OY 21-Sep-06 Lyrica 150mg Hard capsules 56 AT/BE/CY/FR/DE/GR/IE/IT/LU/MT/NO/PT/ES/ NL/UK

FI 10-Jan-07

Paranova A/S 27-Dec-06 Lyrica 150mg Hard capsules 56 AT/BE/FI/FR/DE/GR/IT/NL/NO/PT/ES/SE/UK

DK 8-Mar-07

Paranova AB 04-Apr-07 Lyrica 150mg Hard capsules 56 AT/BE/FI/FR/DE/GR/IT/NL/NO/PT/ES/UK

SE 19-Apr-07


UK/IE 27-Mar-07

Polyfarma Ltd 30-May-07 Lyrica 150mg Hard capsules 56 AT/BE/FR/DE/GR/IE/IT/ NL/PT/ES

UK/IE 17-Dec-07


10-Jul-06 Lyrica 150mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 25-Apr-07



UK 28-Jun-07


14-Sep-06 Lyrica 150mg Hard capsules 56 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/PT/ES/SE

UK 26-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 83/153



UK 26-Apr-07

A.C.A. Muller 19-Mar-07 Lyrica 200mg Hard capsules 21 AT DE 8-Jun-07

B&S Healthcare 05-Dec-06 Lyrica 200mg Hard capsules 84 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 30-Jan-07

Beragena 22-Mar-05 Lyrica 200mg Hard capsules 21 AT DE 3-May-07

BR Lewis 26-Jun-07 Lyrica 200mg Hard capsules 84 AT/BT/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/ NL/NO/PT/ES/SE/UK

UK/IE/MT 13-Sep-07

G-Pharma 09-Mar-07 Lyrica 200mg Hard capsules 84 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 26-Mar-07

Lexon 13-Sep-07 Lyrica 200mg Hard capsules 84 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 7-Dec-07

Pharma Westen 03-Apr-06 Lyrica 200mg Hard capsules 21 AT/BE/CY/CZ/DK/EE/ GR/ES/FI/FR/HU/IE/IS/ IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE/UK

DE 26-Apr-07



UK 28-Jun-07


10-Jan-07 Lyrica 200mg Hard capsules 84 AT/BE/CY/CZ/DE/DK/ GR/ES/FI/FR/IE/IS/IT/LV/LI/LU/MT/NL/NO/PL/ PT/SI/SK/SE

UK 11-Jun-07


19-Feb-07 Lyrica 200mg Hard capsules 84 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/PT/ES/SE

UK 26-Apr-07


UK 19-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 84/153

Colorama 17-Apr-07 Lyrica 25mg Hard capsules 100x1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 18-Sep-07


UK 19-Nov-07


UK 2-Aug-07

Dowelhurst Ltd 06-Mar-07 Lyrica 25mg Hard capsules 100x1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 2-Aug-07

Lexon 26-Feb-07 Lyrica 25mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 28-Mar-07

Lexon 08-Jan-07 Lyrica 25mg Hard capsules 84 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 19-Apr-07


UK 4-May-07


UK 4-May-07

N.G. Ltd 03-May-05 Lyrica 25mg Hard capsules 100x1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 9-Nov-07


13-Feb-07 Lyrica 25mg Hard capsules 21 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 22-Jun-07


UK/IE 27-Mar-07

PCO Ltd 18-Oct-07 Lyrica 25mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IT/LU/MT/NL/PT/ ES/SE/UK

UK/IE 5-Nov-07

SRL Pharmaceuticals

12-May-06 Lyrica 25mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 16-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 85/153



UK 28-Jun-07



UK 28-Jun-07


19-Apr-07 Lyrica 25mg Hard capsules 14 AT/BE/CY/CZ/DE/DK/ GR/ES/FI/FR/IE/IS/IT/LV/LI/LU/MT/NL/NO/PL/ PT/SI/SK/SE

UK 20-Aug-07


19-Apr-07 Lyrica 25mg Hard capsules 100x1 AT/BE/CY/CZ/DE/DK/ GR/ES/FI/FR/IE/IS/IT/LV/LI/LU/MT/NL/NO/PL/ PT/SI/SK/SE

UK 20-Aug-07

Waymade 07-Nov-06 Lyrica 25mg Hard capsules 84 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 28-Mar-07



UK 26-Apr-07



UK 26-Jun-07



UK 2-Jul-07

BR Lewis 25-Apr-07 Lyrica 300mg Hard capsules 56 AT/BE/BG/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/ LU/NL/NO/PL/RO/PT/ SK/SI/ES/SE/UK

UK/IE/MT 23-May-07

Eurim-Pharm 01-Jul-05 Lyrica 300mg Hard capsules 56 UK/IT DE 8-Mar-07

Eurim-Pharm 01-Jul-05 Lyrica 300mg Hard capsules 100x1 UK/IT DE 8-Mar-07

G-Pharma 09-Mar-07 Lyrica 300mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 26-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 86/153

G-Pharma 30-Jan-07 Lyrica 300mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 30-Nov-07

Intercare 13-Feb-07 Lyrica 300mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 2-Mar-07

Kohlpharma 15-Jun-07 Lyrica 300mg Hard capsules 100 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 30-Jul-07

Kohlpharma 23-Apr-07 Lyrica 300mg Hard capsules 56 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 9-Aug-07

Kohlpharma 15-Jun-07 Lyrica 300mg Hard capsules 100 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 12-Sep-07


UK 4-May-07

Paranova AB 12-Apr-07 Lyrica 300mg Hard capsules 56 AT/BE/FI/FR/DE/IT/NL/NO/PT/ES/UK

SE 19-Apr-07

Paranova OY 21-Jun-07 Lyrica 300mg Hard capsules 14 UK FI 12-Jul-07

Paranova OY 21-Jun-07 Lyrica 300mg Hard capsules 56 UK FI 12-Jul-07


10-Jan-07 Lyrica 300mg Hard capsules 56 AT/BE/CY/CZ/DE/DK/ GR/ES/FI/FR/IE/IS/IT/LV/LI/LU/MT/NL/NO/PL/ PT/SI/SK/SE

UK 11-Jun-07



UK 26-Apr-07

Beragena 24-May-06 Lyrica 50mg Hard capsules 21 IT DE 3-May-07

BR Lewis 10-Jan-07 Lyrica 50mg Hard capsules 21 AT/BE/CY/CZ/DE/DK/ GR/ES/FI/FR/IE/IS/IT/LV/LI/LU/NL/NO/PL/PT/SI/SK/SE/UK

UK/IE/MT 30-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 87/153


UK 19-Mar-07


UK 19-Nov-07


UK 7-Aug-07

Dowelhurst Ltd 01-Nov-06 Lyrica 50mg Hard capsules 21 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 14-Sep-07

Emra-Med 21-Aug-06 Lyrica 50mg Hard capsules 21 IT/PT DE 25-Jun-07

G-Pharma 27-Dec-06 Lyrica 50mg Hard capsules 21 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 5-Feb-07

Lexon 26-Feb-07 Lyrica 50mg Hard capsules 84 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 28-Mar-07

Paranova AB 16-Mar-07 Lyrica 50mg Hard capsules 56 PT SE 24-May-07


UK/IE 27-Mar-07



UK 28-Jun-07


19-Apr-07 Lyrica 50mg Hard capsules 21 AT/BE/CY/CZ/DE/DK/ GR/ES/FI/FR/IE/IS/IT/LV/LI/LU/MT/NL/NO/PL/ PT/SI/SK/SE

UK 20-Aug-07

Waymade 15-Feb-07 Lyrica 50mg Hard capsules 56 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 28-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 88/153


10-Apr-07 Lyrica 50mg Hard capsules 84 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/PT/ES/SE

UK 6-Jun-07

Beragena 22-Mar-05 Lyrica 75mg Hard capsules 56 BE DE 3-May-07


UK 19-Mar-07


UK 19-Mar-07

Dowelhurst Ltd 06-Jul-07 Lyrica 75mg Hard capsules 100x1 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LV/LI/ LU/MT/NL/NO/PL/PT/ SK/SI/ES/SE

UK 3-Aug-07

Ginova 22-Aug-07 Lyrica 75mg Hard capsules 14 AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 7-Sep-07


UK 30-Nov-07


UK 30-Nov-07

Intercare 08-Apr-05 Lyrica 75mg Hard capsules 56 AT/BE/DK/FI/FR/DE/GR/IE/IT/NL/PT/ES/SE

UK/IE 19-Feb-07

Kohlpharma 17-Oct-06 Lyrica 75mg Hard capsules 100x1 AT/BE/CZ/FR/GR/IE/IT/NL/NO/PT/ES/SE/UK

DE 1-Aug-07


UK 4-May-07


UK 4-May-07

N.G. Ltd 03-May-05 Lyrica 75mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 1-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 89/153

Orifarm OY 21-Sep-06 Lyrica 75mg Hard capsules 56 AT/BE/CY/FR/DE/GR/IE/IT/LU/MT/NO/PT/ES/ NL/UK

FI 10-Jan-07

Paranova AB 23-Mar-07 Lyrica 75mg Hard capsules 56 AT/BE/FI/FR/DE/GR/IT/NL/NO/PT/ES/UK

SE 24-May-07


UK/IE 27-Mar-07


10-Jul-06 Lyrica 75mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 25-Apr-07

SRL Pharmaceuticals

12-May-06 Lyrica 75mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 16-Apr-07

Testerworld Ltd 29-Aug-07 Lyrica 75mg Hard capsules 56 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 4-Sep-07


08-Mar-07 Lyrica 75mg Hard capsules 14 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 14-Jun-07

Fisher Farma 05-Dec-06 MabThera 100mg Concentrate for solution for injection


NL 2-Jul-07


29-Jan-07 Mabthera 100mg Concentrate for solution for injection

2 FR/UK DE 22-Jun-07

Pharma Westen 12-May-06 MabThera 100mg Concentrate for solution for injection


DE 11-Apr-07

CC Pharma 03-Nov-06 MabThera 500mg Concentrate for solution for injection

1 GR/NO/ES/UK DE 23-May-07

Fisher Farma 05-Dec-06 MabThera 500mg Concentrate for solution for injection


NL 2-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 90/153


29-Jan-07 Mabthera 500mg Concentrate for solution for injection

1 FR/UK DE 22-Jun-07

Pharma Westen 12-May-06 MabThera 500mg Concentrate for solution for injection


DE 11-Apr-07

B&S Healthcare 25-Oct-07 Micardis 20mg Tablets 28 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK/IE 13-Dec-07

Ginova 14-Sep-06 Micardis 20mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 29-Mar-07

G-Pharma 09-Oct-06 Micardis 20mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 24-Jan-07


17-Jan-07 Micardis 20mg Tablets 28 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 20-Apr-07

BR Lewis 12-Apr-07 Micardis 40mg Tablets 28 AT/BE/CY/CZ/DK/FR/ DE/GR/IS/IE/IT/LI/LU/ NL/NO/PT/ES/SE/UK

UK/IE/MT 26-May-07

Mediport 03-Apr-07 Micardis 40mg Tablets 28 AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 20-Apr-07

Orifarm OY 18-Oct-07 Micardis 40mg Tablets 28 AT/BE/CY/CZ/DK/FR/ DE/GR/IS/IE/IT/LI/LU/ MT/NL/NO/PT/ES/SE/ UK

FI 29-Nov-07


FI 29-Nov-07

Pharma Westen 11-Oct-06 Micardis 40mg Tablets 28 AT/BE/CY/CZ/DK/EE/FI/FR/GR/HU/IT/IE/IS/LI/ LU/LT/LV/MT/NL/NO/ PL/PT/SI/SK/ES/SE/UK

DE 24-Sep-07

EMEA/311899/2008 © EMEA 2008 Page 91/153


DE 24-Sep-07


DE 24-Sep-07

Pharma Westen 11-Oct-06 Micardis 40mg Tablets 28 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 24-Sep-07


DE 24-Sep-07


DE 24-Sep-07

SinGad Pharma ApS

13-Aug-07 Micardis 40mg Tablets 28 AT/FR/DE/GR/IT/NL/PT/ ES/UK

DK 6-Dec-07


04-Sep-06 Micardis 40mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/PT/ES/SE

UK 11-Jan-07

BR Lewis 12-Apr-07 Micardis 80mg Tablets 28 AT/BE/CY/CZ/DK/FR/ DE/GR/IS/IE/IT/LI/LU/ NL/NO/PT/ES/SE/UK

UK/IE/MT 26-May-07


FI 16-Nov-07


FI 16-Nov-07

Paranova A/S 17-Mar-06 Micardis 80mg Tablets 98 AT/BE/FI/FR/DE/GR/IE/ IT/NL/PT/ES/SE/UK

DK 19-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 92/153


DE 24-Sep-07


DE 24-Sep-07


DE 24-Sep-07


DE 24-Sep-07


DE 24-Sep-07


DE 24-Sep-07


04-Sep-06 Micardis 80mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/PT/ES/SE

UK 11-Jan-07

B&S Healthcare 15-Feb-07 MicardisPlus 40/12.5mg Tablets 28 AT/BE/CZ/EE/FR/DE/GR/HU/IT/LV/LT/NL/PL/PT/SK/SI/ES

UK/IE 23-Feb-07

Orifarm AS 29-Mar-07 MicardisPlus 40/12.5mg Tablets 28 AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DK 10-May-07

Orifarm AS 29-Mar-07 MicardisPlus 40/12.5mg Tablets 98 AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DK 10-May-07

Orifarm OY 29-Mar-07 MicardisPlus 40/12.5mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE/UK

FI 10-May-07

EMEA/311899/2008 © EMEA 2008 Page 93/153

Orifarm OY 29-Mar-07 MicardisPlus 40/12.5mg Tablets 98 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE/UK

FI 10-May-07

BR Lewis 12-Dec-06 MicardisPlus 80/12.5 mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/NL/ NO/PT/ES/SE/UK

UK/IE/MT 26-Jan-07

Chemilines Ltd 19-Dec-05 MicardisPlus 80/12.5mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 19-Jun-07

Ginova 29-Oct-07 MicardisPlus 80/12.5mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 14-Dec-07

Mediport 03-Apr-07 MicardisPlus 80/12.5mg Tablets 28 AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 20-Apr-07

SinGad Pharma ApS

13-Aug-07 MicardisPlus 80/12.5mg Tablets 28 AT/FR/DE/GR/IT/NL/PT/ ES/UK

DK 6-Dec-07

Euroregistratie BV 14-Nov-07 Mimpara 30mg Film-coated tablets


NL 11-Dec-07

Euroregistratie BV 14-Nov-07 Mimpara 60mg Film-coated tablets


NL 11-Dec-07

AxiCorp Pharma 24-Jan-07 Mirapexin 0.18mg Tablets 30 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 26-Apr-07

AxiCorp Pharma 24-Jan-07 Mirapexin 0.18mg Tablets 100 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 26-Apr-07

Cross Pharma AB 25-May-07 Mirapexin 0.18mg Tablets 30 BE/GR/IT/NL/PT/ES SE 1-Aug-07


GenPlus Ltd 09-Aug-07 Mirapexin 0.18mg Tablets 100 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 27-Sep-07

G-Pharma 30-Oct-06 Mirapexin 0.18mg Tablets 30 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 11-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 94/153


UK 11-Jan-07

Paranova AB 21-Jun-07 Mirapexin 0.18mg Tablets 100 BE/GR/IT/ES SE 12-Jul-07


19-Jun-06 Mirapexin 0.18mg Tablets 30 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 13-Mar-07

SinGad Pharma ApS

08-Mar-07 Mirapexin 0.18mg Tablets 100 ES DK 11-Sep-07

SRL Pharmaceuticals

14-Mar-06 Mirapexin 0.18mg Tablets 100 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK 30-Mar-07


29-Mar-07 Mirapexin 0.18mg Tablets 100 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 28-Jun-07

Testerworld Ltd 30-Jul-07 Mirapexin 0.18mg Tablets 100 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 28-Sep-07

AxiCorp Pharma 07-Sep-06 Mirapexin 0.7mg Tablets 100 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 23-Apr-07


Euroregistratie BV 14-Feb-07 Mirapexin 0.7mg Tablets 30 AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 22-Mar-07

GenPlus Ltd 26-Apr-05 Mirapexin 0.7mg Tablets 100 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 26-Nov-07


UK 11-Jan-07


UK 11-Jan-07

Pharma Gerke 15-Sep-06 Mirapexin 0.7mg Tablets 100 AT/BE/FR/GR/IT/NL/NO/PT/ES/UK

DE 6-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 95/153


19-Jun-06 Mirapexin 0.7mg Tablets 30 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 13-Mar-07

SinGad Pharma ApS

08-Mar-07 Mirapexin 0.7mg Tablets 100 ES DK 11-Sep-07

SRL Pharmaceuticals

06-Jan-06 Mirapexin 0.7mg Tablets 100 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK 13-Mar-07

SRL Pharmaceuticals

06-Jan-06 Mirapexin 0.7mg Tablets 30 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 13-Mar-07


09-Jan-07 Mirapexin 0.7mg Tablets 100 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 1-Jun-07

Testerworld Ltd 30-Jul-07 Mirapexin 0.7mg Tablets 100 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 28-Sep-07


15-Feb-07 Mirapexin 0.7mg Tablets 30 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 15-Mar-07


15-Feb-07 Mirapexin 0.7mg Tablets 100 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 15-Mar-07

Pharma Westen 20-Nov-06 Mixtard 30 Innolet



DE 27-Mar-07

Pharma Westen 20-Nov-06 Mixtard 30 Innolet



DE 27-Mar-07

Intercare 15-Jan-07 Mixtard 30 Penfill


5x3ml AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES

UK/IE 26-Feb-07

Kohlpharma 14-May-07 Mixtard 30 Penfill



DE 29-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 96/153

Kohlpharma 14-May-07 Mixtard 30 Penfill



DE 29-Jun-07




UK/IE 26-Feb-07




UK/IE 26-Feb-07

Pharma Westen 23-Apr-07 NeoRecormon 1.000IU Solution for injection in a pre-filled syringe

6 AT/BE/DK/FI/FR/GR/IE/IS/IT/LU/NL/NO/PT/ES/SE/UK

DE 14-Aug-07

Pharma Westen 05-Nov-07 NeoRecormon 2000IU Solution for injection in a pre-filled syringe


DE 7-Dec-07



DE 7-Dec-07



DE 7-Dec-07



DE 7-Dec-07



DE 7-Dec-07

Kohlpharma 23-Apr-07 Nespo 100µg Solution for injection in a pre-filled syringe


DE 23-May-07

CC Pharma 02-May-06 Nespo 100µg Solution for injection in a pre-filled syringe

1 NO DE 15-Feb-07

Kohlpharma 23-Apr-07 Nespo 150µg Solution for injection in a pre-filled syringe


DE 23-May-07

EMEA/311899/2008 © EMEA 2008 Page 97/153


1 NO DE 15-Feb-07

Kohlpharma 28-Dec-06 Nespo 20µg Solution for injection in a pre-filled syringe


DE 24-Apr-07

Emra-Med 25-Apr-07 Nespo 30µg Solution for injection in a pre-filled syringe

4 IT DE 23-May-07



DE 24-Apr-07


1 NO DE 15-Feb-07

Emra-Med 25-Apr-07 Nespo 40µg Solution for injection in pre-filled syringe

4 IT DE 23-May-07



DE 24-Apr-07

Pharma Westen 23-May-07 Nespo 40µg Solution for injection in a pre-filled syringe


DE 17-Jul-07


1 NO DE 15-Feb-07


4 IT DE 23-May-07



DE 24-Apr-07



DE 17-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 98/153


1 NO DE 15-Feb-07


4 IT DE 23-May-07



DE 24-Apr-07



DE 17-Jul-07


1 NO DE 15-Feb-07


4 IT DE 23-May-07



DE 24-Apr-07

Pharma Westen 05-Mar-07 Nespo 80µg Solution for injection in a pre-filled syringe


DE 17-Jul-07


1 NO DE 15-Feb-07

CC Pharma 02-May-06 Nespo Sureclick 20µg Solution for injection in a pre-filled pen

1 NO DE 15-Feb-07

Medartuum AB 16-Apr-07 Neulasta 6mg Solution for injection in a pre-filled syringe


SE 12-Jul-07

Omnia Läkemedel AB

27-Dec-06 Neulasta 6mg Solution for injection in a pre-filled syringe

1 BE/FR/DE/GR/IE/IT/NL/ PT/ES/UK

SE 29-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 99/153

Pharma Westen 12-Feb-07 Neulasta 6mg Solution for injection in a pre-filled syringe


DE 25-Sep-07

CC Pharma 16-Mar-07 Neupopeg 6mg Solution for injection in a pre-filled syringe

1 IT DE 20-Jul-07

Emra-Med 30-Jul-07 Neupopeg 6mg Solution for injection in a pre-filled syringe

1 IT DE 24-Sep-07

Emra-Med 25-May-07 Neupro 2 mg/24 h Transdermal patches

7 AT DE 5-Nov-07

Emra-Med 25-Jan-07 Neupro 2 mg/24 h Transdermal patches

28 AT/UK DE 5-Nov-07

Kohlpharma 31-Jan-07 Neupro 2 mg/24 h Transdermal patches


DE 23-May-07

Kohlpharma 27-Mar-07 Neupro 2 mg/24 h Transdermal patches


DE 23-May-07

Kohlpharma 30-May-07 Neupro 2 mg/24 h Transdermal patches


DE 17-Jul-07

Kohlpharma 30-Jul-07 Neupro 2 mg/24 h Transdermal patches

84 AT/BE/FR/IE/IT/NL/NO/ES/SE/UK

DE 3-Dec-07

Orifarm AS 25-Jun-07 Neupro 2 mg/24 h Transdermal patches


DK 4-Dec-07

Pharma Westen 20-Sep-06 Neupro 2 mg/24 h Transdermal patches


DE 16-Aug-07

CC Pharma 17-Apr-07 Neupro 4 mg/24 h Transdermal patches


DE 26-Jul-07



DE 26-Jul-07



DE 26-Jul-07

Emra-Med 19-Mar-07 Neupro 4 mg/24 h Transdermal patches

7 AT DE 12-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 100/153


28 AT DE 12-Apr-07


100 AT DE 12-Apr-07



DE 30-Apr-07



DE 23-May-07

Kohlpharma 23-Apr-07 Neupro 4 mg/24 h Transdermal patches


DE 9-May-07

Kohlpharma 30-May-07 Neupro 4 mg/24 h Transdermal patches


DE 17-Jul-07



DK 4-Dec-07

Pharma Gerke 09-Jul-07 Neupro 4 mg/24 h Transdermal patches

84 AT/BE/FR/DE/IT/NL/NO/PT/ES/UK

DE 6-Aug-07



DE 6-Aug-07

Pharma Gerke 02-Apr-07 Neupro 4 mg/24 h Transdermal patches


DE 6-Aug-07

Pharma Gerke 25-Sep-07 Neupro 4 mg/24 h Transdermal patches


DE 11-Oct-07



DE 16-Aug-07

CC Pharma 10-May-07 Neupro 6 mg/24 h Transdermal patches


DE 26-Jul-07



DE 26-Jul-07



DE 26-Jul-07


7 AT DE 12-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 101/153


28 AT DE 12-Apr-07


100 AT DE 12-Apr-07



DE 30-Apr-07



DE 23-May-07



DE 9-May-07



DE 3-Dec-07



DK 4-Dec-07



DE 6-Aug-07



DE 6-Aug-07



DE 6-Aug-07



DE 16-Aug-07

CC Pharma 10-May-07 Neupro 8 mg/24 h Transdermal patches


DE 26-Jul-07



DE 26-Jul-07



DE 26-Jul-07


7 AT DE 12-Apr-07


28 AT DE 12-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 102/153


100 AT DE 12-Apr-07



DE 30-Apr-07



DE 9-May-07



DE 23-May-07



DE 3-Dec-07



DK 4-Dec-07



DE 6-Aug-07



DE 6-Aug-07



DE 6-Aug-07



DE 6-Aug-07



DE 16-Aug-07

Kohlpharma 17-Aug-07 Norvir 100mg Soft capsules 84 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 3-Oct-07

Medico Pharm 31-Jul-07 Norvir 100mg Soft capsules 84 AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/PT/ES/SE/UK

DE 22-Aug-07

Omnia Läkemedel AB

20-Mar-07 Norvir 100mg Soft capsules 336 BE/FR/DE/GR/IE/IT/NL/ PT/ES/UK

SE 29-May-07

Pharma Gerke 17-Oct-06 Norvir 100mg Soft capsules 336 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 14-Nov-07

EMEA/311899/2008 © EMEA 2008 Page 103/153

Pharma Westen 13-Jan-06 Norvir 100mg Soft capsules 336 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 25-Sep-07

Chemilines Ltd 18-Apr-06 Novomix 30 Flexpen

100IU/ml Suspension for injection in pre-filled pen

5 pens AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 9-May-07

Delphi BV 28-Jun-07 NovoMix 30 Flexpen



NL 12-Jul-07

Intercare 15-Jan-07 Novomix 30 Flexpen


5 pens AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES

UK/IE 6-Mar-07


24-Apr-07 Novomix 30 Flexpen



UK 23-Aug-07

Lexon 12-Jun-06 Novomix 30 Flexpen

100U/ml Suspension for injection in a pre-filled pen


UK 9-Jan-07

Chemilines Ltd 18-Apr-06 NovoMix 30 Penfill



UK 9-May-07

Paranova AS 20-Aug-07 Novonorm 0,5mg Tablets 90 AT/BE/FI/FR/DE/GR/IT/NL/NO/PT/ES/SE/UK

DK 28-Nov-07

SRL Pharmaceuticals

23-Feb-07 Novonorm 0,5mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 29-Nov-07

Allpharm 06-Mar-06 Novonorm 0.5mg Tablets 120 GR DE 3-Jul-07

Beragena 10-May-05 Novonorm 0.5mg Tablets 120 BE/GR DE 11-Jul-07

G-Pharma 26-Oct-06 Novonorm 0.5mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 8-Mar-07

Pharma Gerke 09-Oct-06 NovoNorm 0.5mg Tablets 120 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 22-May-07

EMEA/311899/2008 © EMEA 2008 Page 104/153

Allpharm 06-Mar-06 Novonorm 1mg Tablets 120 GR DE 3-Jul-07

Beragena 10-May-05 Novonorm 1mg Tablets 120 BE/GR DE 11-Jul-07

G-Pharma 23-Oct-06 Novonorm 1mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 8-Mar-07

Pharma Gerke 09-Oct-06 NovoNorm 1mg Tablets 120 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 22-May-07

Allpharm 06-Mar-06 Novonorm 2mg Tablets 120 GR DE 3-Jul-07

Beragena 10-May-05 Novonorm 2mg Tablets 120 BE/FR/GR DE 11-Jul-07

G-Pharma 20-Oct-06 Novonorm 2mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 8-Mar-07

Pharma Gerke 09-Oct-06 NovoNorm 2mg Tablets 120 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 22-May-07


30-May-06 NovoNorm 2mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/PT/ES/ SE

UK 15-Mar-07

Chemilines Ltd 22-Feb-06 NovoRapid 100IU/ml Solution for injection in a vial


UK 7-Jun-07

Colorama 31-Mar-03 NovoRapid 100IU/ml Solution for injection in a vial

1x10 ml AT/BE/DK/FI/FR/DE/GR/IT/LU/NL/PT/ES/SE

UK/IE 27-Jul-07

Emra-Med 16-May-06 NovoRapid 100IU/ml Solution for injection in a vial

5x10ml BE/FR DE 17-Dec-07

Intercare 15-Jan-07 NovoRapid 100IU/ml Solution for injection


UK/IE 9-Mar-07

Ginova 29-Nov-06 NovoRapid 100IU/ml Solution for injection in a vial


UK 18-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 105/153

BR Lewis 25-May-07 Novorapid Flexpen


5 pens AT/BE/CY/DE/FI/FR/DE/ GR/IS/IE/IT/LI/LU/NL/ NO/PT/ES/SE/UK

UK 2-Jul-07

Delphi BV 18-Jun-07 NovoRapid Flexpen



NL 28-Nov-07

Ginova 15-Feb-07 NovoRapid Flexpen


5 pens AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 29-Mar-07

Intercare 15-Jan-07 Novorapid Flexpen


5 pens AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES

UK/IE 19-Mar-07

Lexon 02-Jun-06 Novorapid Flexpen



UK 19-Feb-07


24-Apr-07 NovoRapid Flexpen



UK 16-Jul-07

Dowelhurst Ltd 06-Dec-05 NovoRapid FlexPen

100U/ml Solution for injection in a pre-filled pen

5 pens AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 25-Jan-07

Ginova 15-Feb-07 NovoRapid Penfill



UK 29-Mar-07

Lexon 04-Jun-07 NovoRapid Penfill


5x3ml AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/PT/ES/SE

UK 5-Jul-07

Pharma Gerke 12-Jan-07 Novorapid Penfill


10x3ml AT/BE/FR/CZ/GR/IT/NO/PT/ES/UK

DE 25-Jun-07


12-Dec-05 NovoRapid Penfill



UK 1-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 106/153


24-Apr-07 NovoRapid Penfill



UK 16-Jul-07

A.C.A. Mueller 29-Aug-06 Novorapid Penfill


5x3ml FR DE 21-Feb-07

A.C.A. Mueller 29-Aug-06 Novorapid Penfill


5x3ml FR DE 21-Feb-07

Beragena 23-May-07 NutropinAq 10mg/2ml Solution for injection in a cartridge


DE 3-Oct-07

Beragena 23-May-07 NutropinAq 10mg/2ml Solution for injection in a cartridge


DE 3-Oct-07

Kohlpharma 12-Feb-07 NutropinAq 10mg/2ml Solution for injection in a cartridge


DE 27-Jul-07

Pharma Gerke 26-Jan-07 NutropinAq 10mg/2ml Solution for injection in a cartridge

6 NO DE 7-Mar-07

Pharma Gerke 07-Nov-06 NutropinAq 10mg/2ml Solution for injection in a cartridge

1 NO DE 7-Mar-07

Pharma Westen 02-Apr-07 NutropinAq 10mg/2ml Solution for injection in a cartridge


DE 2-Jul-07

Pharma Westen 02-Apr-07 NutropinAq 10mg/2ml Solution for injection in a cartridge


DE 2-Jul-07

Omnia Läkemedel AB

04-Apr-07 NutropinAq 10mg/2ml Solution for injection in a cartridge


SE 26-May-07

CC Pharma 26-Jan-07 NutropinAq 10mg/2ml Solution for injection in a cartridge


DE 10-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 107/153

CC Pharma 07-Nov-06 NutropinAq 10mg/2ml Solution for injection in a cartridge


DE 10-Apr-07

Emra-Med 22-Jun-07 NutropinAq 10mg/2ml Solution for injection in a cartridge

1 AT/FR DE 5-Nov-07

Emra-Med 22-Jun-07 NutropinAq 10mg/2ml Solution for injection in a cartridge

6 AT/FR DE 5-Nov-07

Kohlpharma 12-Feb-07 NutropinAq 10mg/2ml Solution for injection in a cartridge


DE 31-Aug-07


28-Mar-07 Opatanol 1mg/ml Eye drops solution

1 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PL/PT/ES/SE/UK

UK/IE 2-Jul-07

B&S Healthcare 03-Jan-07 Optruma 60mg Film-coated tablets


UK/IE 12-Jan-07

B&S Healthcare 26-Jul-06 Optruma 60mg Film-coated tablets


UK/IE 12-Jan-07

Kohlpharma 10-Apr-07 Pegasys 135µg Solution for injection in a pre-filled syringe


DE 21-May-07

Kohlpharma 23-Apr-07 Pegasys 135µg Solution for injection in a pre-filled syringe


DE 5-Jul-07

CC Pharma 01-Nov-06 Pegasys 180µg Solution for injection in a pre-filled syringe

4+4 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 12-Jul-07

Kohlpharma 01-Dec-06 PegIntron 100µg Powder and solvent for solution for injection


DE 4-Sep-07

Pharma Westen 20-Jul-07 PegIntron 100µg Powder and solvent for solution for injection

4+4+8 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 22-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 108/153

CC Pharma 20-Aug-07 PegIntron 100µg Powder and solvent for solution for injection in a pre-filled pen

12+12+ 24

AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 5-Nov-07

CC Pharma 20-Aug-07 PegIntron 120µg Powder and solvent for solution for injection in a pre-filled pen

12+12+ 24

AT/BE/FR/GR/IT/NO/PT/ES/UK

DE 5-Nov-07

Kohlpharma 27-Mar-07 PegIntron 120µg Powder and solvent for solution for injection

4 pens AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 29-May-07


12-Jan-07 Plavix 75mg Film-coated tablets


UK/IE 20-Aug-07

Euroregistratie BV 02-Oct-07 Plavix 75mg Film-coated tablets


NL 17-Oct-07

Ginova 04-Oct-06 Plavix 75mg Film-coated tablets


UK 8-Jan-07

G-Pharma 15-Nov-06 Plavix 75mg Film-coated tablets


UK 9-Jan-07

Medartuum AB 16-Oct-06 Plavix 75mg Film-coated tablets


SE 11-Jul-07

Orifarm AB 12-Nov-07 Plavix 75mg Film-coated tablets

28 AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 6-Dec-07



SE 6-Dec-07



SE 6-Dec-07

EMEA/311899/2008 © EMEA 2008 Page 109/153

Orifarm AS 12-Nov-07 Plavix 75mg Film-coated tablets


DK 6-Dec-07

Orifarm OY 10-Aug-07 Plavix 75mg Film-coated tablets

84 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NO/PT/SE/NL/UK

FI 7-Sep-07

Orifarm OY 10-Aug-07 Plavix 75mg Film-coated tablets

28 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NO/PT/SE/NL/UK

FI 7-Sep-07


25-Aug-06 Plavix 75mg Film-coated tablets


UK 24-Apr-07

SIA "Elpis" 29-Oct-07 Plavix 75mg Film-coated tablets

28 PL LV 13-Dec-07

Testerworld Ltd 07-Sep-06 Plavix 75mg Film-coated tablets

28 (b) AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 15-Feb-07

Veron Pharma 07-Sep-07 Plavix 75mg Film-coated tablets

28 AT/BE/CY/FR/GR/IT/NL/PT/ES/UK

DE 4-Dec-07

Veron Pharma 07-Sep-07 Plavix 75mg Film-coated tablets


DE 4-Dec-07

Waymade 13-Nov-07 Plavix 75mg Film-coated tablets

100 NO UK 5-Dec-07


31-Oct-06 Plavix 75mg Film-coated tablets


UK 11-Jul-07


22-Jan-07 Prandin 0.5mg Tablets 30 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/ES/SE/UK

UK/IE 21-Aug-07


22-Jan-07 Prandin 0.5mg Tablets 90 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/ES/SE/UK

UK/IE 21-Aug-07

Dowelhurst Ltd 11-Jun-07 Prandin 0.5mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 25-Jul-07

Intercare 14-May-07 Prandin 0.5mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 25-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 110/153

Lexon 17-Sep-07 Prandin 0.5mg Tablets 90 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 24-Oct-07


10-Aug-07 Prandin 0.5mg Tablets 90 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 13-Dec-07


14-Mar-07 Prandin 0.5mg Tablets 90 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 30-Aug-07

Waymade 04-May-07 Prandin 0.5mg Tablets 90 AT/BE/FR/DE/GR/IT/NL/NO/PT/ES

UK 1-Jun-07


22-Jan-07 Prandin 1mg Tablets 30 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/ES/SE/UK

UK/IE 21-Aug-07



UK/IE 21-Aug-07

Dowelhurst Ltd 11-Jun-07 Prandin 1mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 25-Jul-07

Intercare 14-May-07 Prandin 1mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 25-Oct-07

Lexon 17-Sep-07 Prandin 1mg Tablets 90 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 24-Oct-07


10-Aug-07 Prandin 1mg Tablets 90 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 13-Dec-07


14-Mar-07 Prandin 1mg Tablets 90 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 30-Aug-07

Waymade 04-May-07 Prandin 1mg Tablets 90 AT/BE/FR/DE/GR/IT/NL/NO/PT/ES

UK 1-Jun-07



UK/IE 21-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 111/153



UK/IE 21-Aug-07

Dowelhurst Ltd 11-Jun-07 Prandin 2mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 25-Jul-07

Intercare 14-May-07 Prandin 2mg Tablets 90 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 25-Oct-07

Lexon 17-Sep-07 Prandin 2mg Tablets 90 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 24-Oct-07


22-Jun-07 Prandin 2mg Tablets 90 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 17-Oct-07


14-Mar-07 Prandin 2mg Tablets 90 AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 30-Aug-07

Waymade 04-May-07 Prandin 2mg Tablets 90 AT/BE/FR/DE/GR/IT/NL/NO/PT/ES

UK 1-Jun-07

Chemilines Ltd 15-Jun-07 Pritor 20mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/IT/ES/SE

UK/IE 12-Oct-07

Dowelhurst Ltd 17-Oct-07 Pritor 20mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 7-Dec-07

G-Pharma 03-Oct-06 Pritor 20mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 1-Feb-07

Intercare 13-Apr-07 Pritor 20mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK/IE 21-May-07


24-Apr-07 Pritor 20mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 15-May-07

EMEA/311899/2008 © EMEA 2008 Page 112/153

Waymade 23-Apr-07 Pritor 20mg Tablets 28 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 21-May-07

Chemilines Ltd 12-Jul-07 Pritor 40mg Tablets 28 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PL/PT/SK/SI/ES/SE

UK/IE 12-Oct-07

G-Pharma 11-Jan-07 Pritor 40mg Tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 8-Feb-07


UK/IE 21-May-07


22-Feb-07 Pritor 40mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 15-May-07

Waymade 16-Jan-07 Pritor 40mg Tablets 28 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 2-Mar-07


UK/IE 21-May-07


22-Feb-07 Pritor 80mg Tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 15-May-07

Waymade 16-Jan-07 Pritor 80mg Tablets 28 AT/BE/FR/DE/GR/IT/NL/PT/ES

UK 2-Mar-07

Chemilines Ltd 14-Aug-07 Prometax 1.5mg Hard capsules 56 AT/BE/CY/CZ/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PL/PT/ES/SE

UK/IE 14-Sep-07

Medartuum AB 15-Mar-07 Prometax 1.5mg Hard capsules 112 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 3-May-07


UK/IE 14-Sep-07

Cross Pharma AB 24-Apr-07 Prometax 3.0mg Hard capsules 112 IT SE 3-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 113/153


SE 3-May-07

Paranova AS 25-May-07 Prometax 3.0mg Hard capsules 112 IT/PT/ES DK 5-Jul-07

Paranova AS 31-Aug-07 Prometax 3.0mg Hard capsules 56 IT/PT/ES DK 25-Sep-07


UK/IE 14-Sep-07


SE 3-May-07


UK/IE 14-Sep-07


SE 3-May-07

AxiCorp Pharma 17-Mar-05 Protaphane Penfill


5x3ml GR/IT DE 22-Mar-07

AxiCorp Pharma 17-Mar-05 Protaphane Penfill


10x3ml GR/IT DE 22-Mar-07


28-Mar-07 Protelos 2g Granules for oral suspension

28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PL/PT/ES/SE/UK

UK/IE 16-Jul-07

Mediport 06-Jun-07 Protelos 2g Granules for oral suspension


UK 15-Aug-07


23-Oct-07 Protelos 2g Granules for oral suspension

28 sachets

AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 20-Nov-07

Orifarm A/S 15-Nov-06 Protelos 2g Granules for oral suspension


DK 5-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 114/153

Orifarm A/S 15-Nov-06 Protelos 2g Granules for oral suspension


DK 5-Feb-07


02-Feb-07 Protelos 2g Granules for oral suspension


UK 18-Sep-07

Waymade 21-Feb-07 Protelos 2g Granules for oral suspension


UK 28-Feb-07


5-Nov-07 Protelos 2g Granules for oral suspension


UK 6-Dec-07

Chemilines Ltd 12-Dec-06 Protopic 0.03% Ointment 30g AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 8-Mar-07

Intercare 17-Apr-07 Protopic 0.03% Ointment 30g AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 14-Aug-07


UK/IE 14-Aug-07


30-Jan-07 Protopic 0.03% Ointment 30g AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 14-Aug-07


UK/IE 14-Aug-07


UK/IE 14-Aug-07


30-Jan-07 Protopic 0.10% Ointment 30g AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 14-Aug-07

Orifarm A/S 27-Feb-07 Protopic 0.10% Ointment 30g AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 29-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 115/153

Orifarm A/S 27-Feb-07 Protopic 0.10% Ointment 60g AT/BE/CY/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/NL/UK

DK 29-Mar-07

Orifarm AB 27-Feb-07 Protopic 0.10% Ointment 30g AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/NL/UK

SE 29-Mar-07

Orifarm AB 27-Feb-07 Protopic 0.10% Ointment 60g AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/NL/UK

SE 29-Mar-07

Orifarm OY 27-Feb-07 Protopic 0.10% Ointment 30g AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NO/PT/ES/SE/NL/UK

FI 29-Mar-07

Orifarm OY 27-Feb-07 Protopic 0.10% Ointment 60g AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NO/PT/ES/SE/NL/UK

FI 29-Mar-07

Qdoxx Pharma AB 02-Nov-07 Protopic 0.10% Ointment 30g GR SE 20-Dec-07

Euroregistratie BV 06-Jun-07 Puregon 100 IU/0.5 ml Solution for injection in a cartridge


NL 11-Jul-07



NL 11-Jul-07

Pharma Westen 06-Mar-06 Puregon 200 IU/0.5 ml Solution for injection


DE 6-Aug-07



NL 11-Jul-07


26-Mar-07 Puregon 300 IU/0.36 ml Solution for injection in a cartridge


NL 4-Apr-07

Orifarm A/S 03-Jul-06 Puregon 300 IU/0.36 ml Solution for injection in a cartridge

1 AT/FR/GR/IT/ES DK 8-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 116/153

Orifarm OY 03-Jul-06 Puregon 300 IU/0.36 ml Solution for injection in a cartridge

1 AT/FR/GR/IT/ES FI 8-Feb-07



NL 11-Jul-07


02-Apr-07 Puregon 600 IU/0.72 ml Solution for injection in a cartridge

1 AT/BE/CY/DK/FI/FR/DE/GR/IE/IS/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 19-Apr-07

Orifarm OY 03-Jul-06 Puregon 600 IU/0.72 ml Solution for injection in a cartridge

1 AT/FR/GR/IT/ES FI 8-Feb-07

Eureco-Pharma B.V.

08-Aug-05 Puregon 600 IU/0.72 ml Solution for injection in a cartridge

1 GR NL 19-Jan-07

Euroregistratie BV 19-Jul-07 Puregon 900 IU/1,08 ml Solution for injection in a cartridge

1+3+3 AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 3-Aug-07

Medartuum AB 10-Sep-07 Puregon 900 IU/1,08 ml Solution for injection in a cartridge

1+3+3 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 3-Dec-07

Orifarm AS 22-Dec-06 Puregon 900 IU/1.08 ml Solution for injection in a cartridge

1+3+3 AT/BE/CY/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

DK 26-Apr-07

Orifarm OY 22-Dec-06 Puregon 900 IU/1.08 ml Solution for injection in a cartridge

1+3+3 AT/BE/CY/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

FI 26-Apr-07

Parallell Pharma AB 15-May-06 Rapamune 1mg Coated tablets 100 ES SE 1-Mar-07

Pharma Westen 29-Nov-06 Rapamune 1mg/ml Oral solution 60ml AT/BE/CY/CZ/DK/EE/ GR/ES/FI/FR/HU/IE/IS/ IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE/UK

DE 1-Aug-07

Parallell Pharma AB 15-May-06 Rapamune 2mg Coated tablets 30 ES SE 1-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 117/153

Paranova AB 04-Dec-06 Rapamune 2mg Coated tablets 100 AT/BE/FI/DE/FR/IT/NL/PT/ES/UK

SE 1-Mar-07

Medartuum AB 20-Aug-07 Raptiva 10mg/ml Powder and solvent for solution for injection

4+4+8 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 30-Aug-07

Waymade 23-Nov-07 Rasilez 150mg Film-coated tablets

28 AT/BE/FR/DE/GR/IT/NL/NO/PT/ES

UK 6-Dec-07

Waymade 23-Nov-07 Rasilez 300mg Film-coated tablets

28 AT/BE/FR/DE/GR/IT/NL/NO/PT/ES

UK 6-Dec-07

Emra-Med 04-Jun-07 Rebetol 200mg Hard capsules 84 FR DE 5-Jul-07

Medico Pharm 25-Oct-07 Rebetol 200mg Hard capsules 168 AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE/UK

DE 19-Dec-07

Pharma Gerke 03-Sep-07 Rebetol 200mg Hard capsules 168 AT/BE/FR/GR/IT/NL/NO/PT/LT/ES/UK

DE 20-Dec-07

Pharma Westen 03-May-06 Rebetol 200mg Hard capsules 168 AT/BE/CY/CZ/DK/EE/ GR/ES/FI/FR/HU/IE/IS/ IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE/UK

DE 1-Mar-07

Pharma Westen 30-Jul-07 Rebetol 200mg Hard capsules 84 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LI/LU/NL/NO/PT/ ES/SE/UK

DE 22-Aug-07

Interport 04-Jul-02 Rebif 22µg Solution for injection in a pre-filled syringe

3 GR UK 26-Feb-07


12 FR/GR/IT UK 26-Feb-07


12 GR/IT UK 26-Feb-07

EMEA/311899/2008 © EMEA 2008 Page 118/153

Pharma Gerke 08-Oct-07 Refacto 1000IU Powder and solvent for solution for injection

1+1+1+1+2+1+1


DE 15-Nov-07

Pharma Gerke 08-Oct-07 Refacto 2000IU Powder and solvent for solution for injection

1+1+1+1+2+1+1


DE 15-Nov-07

CC Pharma 04-Jul-06 Remicade 100mg Powder for concentrate for solution for infusion

2 vials BE/FR/GR/NO/PT/ES DE 19-Mar-07

CC Pharma 04-Jul-06 Remicade 100mg Powder for concentrate for solution for infusion

3 vials BE/FR/GR/NO/PT/ES DE 19-Mar-07

Emra-Med 05-Dec-06 Remicade 100mg Powder for concentrate for solution for infusion

1 vial GR DE 10-Jul-07

Emra-Med 11-Apr-07 Remicade 100mg Powder for concentrate for solution for infusion

3 vials GR DE 19-Oct-07

Kohlpharma 10-Apr-07 Remicade 100mg Powder for concentrate for solution for infusion

2 vials AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 10-Jul-07

Pharma Gerke 27-Dec-06 Remicade 100mg Powder for concentrate for solution for infusion

2 vials AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 18-Oct-07

Pharma Gerke 27-Dec-06 Remicade 100mg Powder for concentrate for solution for infusion

3 vials AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 18-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 119/153

Pharma Westen 02-Apr-07 Remicade 100mg Powder for concentrate for solution for injection

2 vials AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 29-May-07

Pharma Westen 02-Apr-07 Remicade 100mg Powder for concentrate for solution for injection

3 vials AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 29-May-07

Delphi BV 03-Nov-06 Renagel 800mg Film-coated tablets

180 AT/BE/FR/GR/IT/PT/ES/ SE

NL 16-Apr-07

Euroregistratie BV 23-Oct-07 Renagel 800mg Film-coated tablets


NL 29-Nov-07

Fisher Farma 09-Nov-07 Renagel 800mg Film-coated tablets

180 (no carton)

AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 14-Dec-07

Kohlpharma 13-Aug-07 Renagel 800mg Film-coated tablets

180 (no carton)

AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 18-Sep-07


15-Nov-07 Renagel 800mg Film-coated tablets

180 (no carton)

AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/ PT/ES/SE/UK

NL 30-Nov-07

Paranova AB 23-Apr-07 Renagel 800mg Film-coated tablets

180 AT/FI/FR/DE/GR/IT/NL/ NO/PT/ES/UK

SE 6-Jun-07

Pharma Westen 10-Sep-07 Renagel 800mg Film-coated tablets


DE 18-Sep-07

Pharmachim AB 12-Mar-07 Renagel 800mg Film-coated tablets


SE 28-Mar-07

Waymade 03-Sep-07 Renagel 800mg Film-coated tablets


UK 19-Oct-07


04-Apr-07 Revatio 20mg Film-coated tablets


NL 29-Jun-07

Beragena 16-Apr-07 Reyataz 150mg Hard capsules 60 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 25-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 120/153

Delfarma 03-Oct-07 Reyataz 150mg Hard capsules 60 AT/BE/BG/CY/CZ/DK/ ES/FI/FR/DE/GR/HU/IS/ IE/IT/LV/LI/LT/LU/MT/NL/NO/PT/RO/SK/SI/ES/SE/UK

PL 5-Nov-07

Emra-Med 19-Oct-06 Reyataz 150mg Hard capsules 60 FR DE 4-Jan-07

Pharma Gerke 26-Feb-07 Reyataz 150mg Hard capsules 60 AT/BE/FR/GR/IT/PT/ES/ UK

DE 13-Sep-07

Beragena 16-Apr-07 Reyataz 200mg Hard capsules 60 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 25-Oct-07

Delfarma 03-Oct-07 Reyataz 200mg Hard capsules 60 AT/BE/BG/CY/CZ/DK/ ES/FI/FR/DE/GR/HU/IS/ IE/IT/LV/LI/LT/LU/MT/NL/NO/PT/RO/SK/SI/ES/SE/UK

PL 5-Nov-07

Emra-Med 11-Aug-06 Reyataz 200mg Hard capsules 60 FR DE 4-Jan-07

Euroregistratie BV 30-Oct-07 Reyataz 200mg Hard capsules 60 AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 6-Dec-07

Pharma Gerke 19-Mar-07 Reyataz 200mg Hard capsules 60 AT/BE/FR/GR/IT/NL/NO/PT/ES/UK

DE 29-Nov-07


02-Oct-07 Rilutek 50mg Film-coated tablets


UK/IE 5-Nov-07

BR Lewis 25-Sep-07 Rilutek 50mg Film-coated tablets


IE/MT/UK 5-Nov-07

Chemilines Ltd 14-Feb-07 Rilutek 50mg Film-coated tablets


UK 5-Apr-07

Dowelhurst Ltd 18-Oct-07 Rilutek 50mg Film-coated tablets


UK 29-Nov-07

EMEA/311899/2008 © EMEA 2008 Page 121/153

Fisher Farma 29-Dec-05 Rilutek 50mg Film-coated tablets


NL 22-Feb-07

Medartuum AB 12-Feb-01 Rilutek 50mg Film-coated tablets

56 AT/BE/DK/CY/DE/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 6-Dec-07

Mediport 13-Jun-07 Rotarix not less than 10 6.0 CCID50

Powder and Solvent for oral suspension

1+1+1 AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 31-Jul-07

G-Pharma 20-Dec-06 Sifrol 0.088mg Tablets 30 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 26-Jan-07


19-Sep-07 Sifrol 0.18mg Tablets 30 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE/UK

UK/IE 8-Nov-07



UK/IE 8-Nov-07

Beragena 29-Jan-07 Sifrol 0.18mg Tablets 100 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 26-Jul-07

Emra-Med 19-Feb-07 Sifrol 0.18mg Tablets 30 FR DE 21-Jun-07

Emra-Med 09-Feb-07 Sifrol 0.18mg Tablets 100 FR DE 21-Jun-07


10-Apr-07 Sifrol 0.18mg Tablets 30 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 10-May-07



UK 10-May-07

Omnia Läkemedel AB

15-Mar-07 Sifrol 0.18mg Tablets 100 BE/FR/DE/GR/IE/IT/NL/ PT/ES/UK

SE 10-May-07

Pharma Westen 20-Jul-06 Sifrol 0.18mg Tablets 30 AT/BE/CY/CZ/DK/EE/ GR/ES/FI/FR/HU/IE/IS/ IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE/UK

DE 12-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 122/153


DE 12-Apr-07


DE 26-Jul-07

Pharma Westen 08-May-07 Sifrol 0.35mg Tablets 100 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 27-Jun-07



UK/IE 8-Nov-07


DE 26-Jul-07

Emra-Med 23-Jan-07 Sifrol 0.7mg Tablets 100 FR DE 21-Jun-07



UK 10-May-07



UK 10-May-07

Omnia Läkemedel AB

15-Mar-07 Sifrol 0.7mg Tablets 100 BE/FR/DE/GR/IE/IT/NL/ PT/ES/UK

SE 10-May-07

Paranova A/S 29-Jan-07 Sifrol 0.7mg Tablets 100 AT/FI/FR/DE/NO/SE DK 27-Feb-07


DE 12-Apr-07

G-Pharma 12-Sep-07 Sonata 10mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 28-Sep-07


12-Feb-07 Sonata 10mg Hard capsules 14 AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/NO/PT/ES/SE

UK 22-May-07

EMEA/311899/2008 © EMEA 2008 Page 123/153


17-Jan-07 Sonata 10mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 16-May-07

G-Pharma 12-Sep-07 Sonata 5mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 28-Sep-07

B&S Healthcare 08-Dec-06 Stalevo 100/25/200mg Film-coated tablets


UK/IE 22-Feb-07

Cross Pharma AB 25-Apr-07 Stalevo 100/25/200mg Film-coated tablets

100 BE/FI/FR/GR/IT/NL/PT/ES

SE 10-May-07

Kullgren Pharma 23-Apr-07 Stalevo 100/25/200mg Film-coated tablets

100 BE DE 11-Sep-07


20-Jun-07 Stalevo 100/25/200mg Film-coated tablets


NL 14-Aug-07

N.G. Ltd 03-May-05 Stalevo 100/25/200mg Film-coated tablets


UK 19-Apr-07

Paranova Oy 10-Mar-06 Stalevo 100/25/200mg Film-coated tablets

30 FR/PT/UK FI 24-Jan-07

Paranova Oy 10-Mar-06 Stalevo 100/25/200mg Film-coated tablets


PCO Ltd 14-Dec-06 Stalevo 100/25/200mg Film-coated tablets


UK/IE 8-Nov-07

Pharma Gerke 05-Oct-06 Stalevo 100/25/200mg Film-coated tablets


DE 1-Feb-07

B&S Healthcare 08-Dec-06 Stalevo 150/37.5/200mg Film-coated tablets


UK/IE 22-Feb-07

G-Pharma 12-Oct-06 Stalevo 150/37.5/200mg Film-coated tablets


UK 13-Feb-07

Kullgren Pharma 23-Apr-07 Stalevo 150/37.5/200mg Film-coated tablets

100 BE DE 11-Sep-07

EMEA/311899/2008 © EMEA 2008 Page 124/153

N.G. Ltd 03-May-05 Stalevo 150/37.5/200mg Film-coated tablets


UK 19-Apr-07

Paranova AS 09-Jul-07 Stalevo 150/37.5/200mg Film-coated tablets

100 AT/BE/FI/FR/DE/NO/PT/ ES/SE/UK

DK 13-Aug-07

Paranova Oy 10-Mar-06 Stalevo 150/37.5/200mg Film-coated tablets




PCO Ltd 14-Dec-06 Stalevo 150/37.5/200mg Film-coated tablets


UK/IE 8-Nov-07

B&S Healthcare 08-Dec-06 Stalevo 50/12.5/200mg Film-coated tablets


UK/IE 22-Feb-07

G-Pharma 11-Oct-06 Stalevo 50/12.5/200mg Film-coated tablets


UK 18-Jan-07

Kullgren Pharma 23-Apr-07 Stalevo 50/12.5/200mg Film-coated tablets

100 BE DE 11-Sep-07

N.G. Ltd 03-May-05 Stalevo 50/12.5/200mg Film-coated tablets


UK 19-Apr-07





PCO Ltd 14-Dec-06 Stalevo 50/12.5/200mg Film-coated tablets


UK/IE 8-Nov-07

B&S Healthcare 19-Mar-07 Starlix 120mg Film-coated tablets


UK/IE 1-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 125/153

Intercare 19-Jul-07 Starlix 120mg Film-coated tablets


UK/IE 6-Aug-07


02-Feb-07 Starlix 120mg Film-coated tablets


UK 18-Sep-07

B&S Healthcare 17-Jan-07 Starlix 180mg Film-coated tablets


UK/IE 22-May-07

Intercare 19-Jul-07 Starlix 180mg Film-coated tablets


UK/IE 6-Aug-07


02-Feb-07 Starlix 180mg Film-coated tablets


UK 18-Sep-07

B&S Healthcare 16-Jan-07 Starlix 60mg Film-coated tablets


UK/IE 22-May-07

Delfarma 21-Aug-07 Stocrin 200mg Hard capsules 90 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PT/RO/SK/SI/ES/SE/UK

PL 12-Dec-07

Delfarma 26-Nov-07 Stocrin 600mg Film-coated tablets

30 (bottle)

AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PT/SK/SI/ES/SE/UK

PL 14-Dec-07

Medartuum AB 25-May-07 Suboxone 2/0.5mg Sublingual tablets


SE 12-Jul-07

Medartuum AB 25-May-07 Suboxone 2/0.5mg Sublingual tablets


SE 12-Jul-07

Medartuum AB 25-May-07 Suboxone 8/2mg Sublingual tablets


SE 12-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 126/153

Medartuum AB 25-May-07 Suboxone 8/2mg Sublingual tablets


SE 12-Jul-07

Medico Pharm 17-Jan-07 Sustiva 600mg Film-coated tablets


DE 12-Mar-07

Fisher Farma 19-Jul-06 Tamiflu 75mg Hard capsules 10 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 6-Jul-07

G-Pharma 24-Nov-06 Tamiflu 75mg Hard capsules 10 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 29-Jan-07

Pharma Westen 23-Apr-07 Tamiflu 75mg Hard capsules 10 AT/BE/DK/FI/FR/GR/IE/IS/IT/LU/NL/NO/PT/ES/SE/ UK

DE 21-May-07

Delfarma 06-Jun-07 Taxotere 20 mg/0.5 ml Concentrate and solvent for solution for infusion

1 BE/CZ/GR PL 7-Aug-07

Delfarma 06-Jun-07 Taxotere 20 mg/0.5 ml Concentrate and solvent for solution for infusion

1 AT/BE/BG/CY/CZ/DK/ ES/FI/FR/DE/GR/HU/IS/ IE/IT/LV/LI/LT/LU/MT/NL/NO/PT/RO/SK/SI/ES/SE/UK

PL 7-Aug-07

Orifarm AB 21-Feb-07 Taxotere 20 mg/0.5 ml Concentrate and solvent for solution for infusion


SE 15-May-07

Orifarm OY 21-Feb-07 Taxotere 20 mg/0.5 ml Concentrate and solvent for solution for infusion


FI 18-Jul-07

Orifarm AB 21-Feb-07 Taxotere 80 mg/0.5 ml Concentrate and solvent for solution for infusion


SE 15-May-07

EMEA/311899/2008 © EMEA 2008 Page 127/153

Orifarm OY 21-Feb-07 Taxotere 80 mg/2 ml Concentrate and solvent for solution for infusion


FI 18-Jul-07

Delfarma 06-Jun-07 Taxotere 80 mg/2 ml Concentrate and solvent for solution for infusion

1 BE/CZ/GR PL 7-Aug-07

Delfarma 06-Jun-07 Taxotere 80 mg/2 ml Concentrate and solvent for solution for infusion


PL 7-Aug-07


29-Jan-07 Taxotere 80 mg/2 ml Concentrate and solvent for solution for infusion

1 FR/UK DE 30-Apr-07

Beragena 27-Feb-07 Telzir 700mg Film-coated tablets


DE 12-Jul-07

CC Pharma 10-Apr-07 Telzir 700mg Film-coated tablets


DE 23-Apr-07

Kohlpharma 27-Mar-07 Telzir 700mg Film-coated tablets


DE 25-Apr-07

Medico Pharm 10-May-07 Telzir 700mg Film-coated tablets


DE 4-Dec-07

Pharma Gerke 13-Aug-07 Telzir 700mg Film-coated tablets


DE 18-Sep-07

Pharma Westen 16-Nov-06 Telzir 700mg Film-coated tablets


DE 11-Jan-07

Emra-Med 11-Apr-07 Temodal 100mg Hard capsules 20 IT DE 18-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 128/153

Kohlpharma 16-Jan-07 Temodal 100mg Hard capsules 20 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 23-Feb-07

Kohlpharma 01-Dec-06 Temodal 100mg Hard capsules 5 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 23-Feb-07

PCO Ltd 30-Apr-07 Temodal 100mg Hard capsules 5 AT/BE/CY/DK/FI/FR/DE/GR/IT/LU/MT/NL/PT/ ES/SE/UK

UK/IE 2-Aug-07

Pharma Gerke 21-Dec-06 Temodal 100mg Hard capsules 5 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 12-Jul-07

Pharma Westen 12-Feb-07 Temodal 100mg Hard capsules 5 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 15-May-07

Fisher Farma 14-May-07 Temodal 20mg Hard capsules 5 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 9-Aug-07


DE 23-Feb-07


DE 12-Jul-07

Pharma Westen 23-Jul-07 Temodal 20mg Hard capsules 20 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 20-Sep-07

Emra-Med 11-Apr-07 Temodal 250mg Hard capsules 5 IT DE 24-Apr-07

Fisher Farma 30-May-07 Temodal 250mg Hard capsules 5 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 2-Jul-07


DE 23-Feb-07


15-Nov-07 Temodal 250mg Hard capsules 5 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/ PT/ES/SE/UK

NL 11-Dec-07

PCO Ltd 30-Apr-07 Temodal 250mg Hard capsules 5 AT/BE/CY/DK/FI/FR/DE/GR/IT/LU/MT/NL/PT/ ES/SE/UK

UK/IE 2-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 129/153


DE 12-Jul-07

Pharma Westen 12-Feb-07 Temodal 250mg Hard capsules 5 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 15-May-07

Kohlpharma 12-Feb-07 Temodal 5mg Hard capsules 20 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 23-Feb-07

Kohlpharma 12-Feb-07 Temodal 5mg Hard capsules 20 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 23-Mar-07

Chemilines Ltd 05-Dec-06 Travatan 40µg/ml Eye drops solution


UK 30-Apr-07

Colorama 27-Nov-06 Travatan 40µg/ml Eye drops solution


UK 17-Apr-07

Intercare 26-Mar-07 Travatan 40µg/mg Eye drops solution


UK/IE 17-Apr-07

BR Lewis 07-Mar-07 Travatan 40µg/ml Eye drops solution


UK/IE/MT 21-Aug-07

Euroregistratie BV 10-Jul-07 Travatan 40µg/ml Eye drops solution


NL 17-Oct-07

Ginova 30-Jul-07 Travatan 40µg/ml Eye drops solution


UK 30-Aug-07

Mediport 25-Apr-07 Travatan 40µg/ml Eye drops solution


UK 27-Jul-07

Parallell Pharma AB 09-May-06 Travatan 40µg/ml Eye drops solution

1 ES SE 8-Aug-07

Parallell Pharma AB 09-May-06 Travatan 40µg/ml Eye drops solution

3 ES SE 8-Aug-07

PCO Ltd 29-Oct-07 Travatan 40µg/ml Eye drops solution


UK/IE 14-Dec-07

EMEA/311899/2008 © EMEA 2008 Page 130/153

Pharmachim AB 27-Jul-07 Travatan 40µg/ml Eye drops solution

3 AT/BE/DE/GR/IT/ES/UK SE 21-Sep-07


10-May-07 Travatan 40µg/ml Eye drops solution


UK 11-Sep-07


20-Jul-07 Travatan 40µg/ml Eye drops solution


UK 17-Aug-07

Beragena 04-Jul-06 Trizivir 300/150/300mg Film-coated tablets


DE 30-Nov-07


21-Mar-07 Trizivir 300/150/300mg Film-coated tablets

60 (bottle)

AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 19-Apr-07

Paranova AB 02-Apr-07 Trizivir 300/150/300mg Film-coated tablets

60 AT/BE/FI/FR/DE/NL/NO/PT/ES/UK

SE 24-May-07

Pharma Westen 20-Jul-07 Trizivir 300/150/300mg Film-coated tablets


DE 20-Aug-07

AxiCorp Pharma 10-Aug-07 Truvada 200/245mg Film-coated tablets


DE 21-Aug-07

Beragena 01-Feb-07 Truvada 200/245mg Film-coated tablets


DE 1-Aug-07

CC Pharma 16-Mar-07 Truvada 200/245mg Film-coated tablets


DE 9-Aug-07

Cross Pharma AB 13-Feb-07 Truvada 200/245mg Film-coated tablets

30 FR SE 7-Aug-07

EU-Pharma B.V. 13-Mar-07 Truvada 200/245mg Film-coated tablets


NL 9-Aug-07

Fisher Farma 06-Nov-06 Truvada 200/245mg Film-coated tablets

30 AT/BE/CY/DK/FI/FR/DE/IS/IT/LI/LU/MT/NO/PT/ES/SE/UK

NL 13-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 131/153

Medartuum AB 12-Mar-07 Truvada 200/245mg Film-coated tablets


SE 9-May-07

Omnia Läkemedel AB

15-Feb-07 Truvada 200/245mg Film-coated tablets


SE 1-Aug-07

Orifarm AB 11-Jan-07 Truvada 200/245mg Film-coated tablets


SE 30-Jan-07

Paranova AS 16-Mar-07 Truvada 200/245mg Film-coated tablets

30 FI/FR/DE/NO/SE/UK DK 28-Jun-07

Pharma Gerke 28-Feb-07 Truvada 200/245mg Film-coated tablets


DE 8-Jun-07

Pharma Westen 26-Jun-06 Twinrix Adult 20µg Suspension for injection in a pre-filled syringe


DE 29-Jun-07



DE 29-Jun-07



DE 29-Jun-07



DE 29-Jun-07

Kohlpharma 27-Dec-06 Twinrix Paediatric

360Elisa Units/10mcg

Suspension for injection in a pre-filled syringe


DE 10-Apr-07

CC Pharma 12-Feb-07 Tysabri 300mg Concentrate for solution for infusion


DE 10-May-07

Emra-Med 01-Feb-07 Tysabri 300mg Concentrate for solution for infusion

1 UK DE 7-May-07

Pharma Gerke 15-Jan-07 Tysabri 300mg Concentrate for solution for infusion

1 AT/BE/CZ/FR/GR/IT/NO/PT/ES/UK

DE 8-Mar-07

EMEA/311899/2008 © EMEA 2008 Page 132/153

Dowelhurst Ltd 22-May-07 Vaniqa 11,5% Cream 30g AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 15-Aug-07

Intercare 13-Apr-07 Vaniqa 11,5% Cream 30g AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK/IE 14-Jun-07

N.G. Ltd 25-Oct-05 Vaniqa 11,5% Cream 30g AT/BE/CY/CZ/DE/DK/ EE/GR/ES/FI/FR/HU/IE/ IS/IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE

UK 26-Jul-07

Pharma Westen 04-Aug-06 Vaniqa 11,5% Cream 30g AT/BE/CY/CZ/DK/EE/ GR/ES/FI/FR/HU/IE/IS/ IT/LV/LI/LT/LU/MT/NL/NO/PL/PT/SI/SK/SE/UK

DE 4-Jan-07


21-Dec-06 Vaniqa 11,5% Cream 30g AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PL/PT/SK/SI/ES/SE

UK 13-Jun-07


06-Nov-06 Vaniqa 11,5% Cream 30g AT/BE/CY/DK/FR/DE/ GR/IE/IT/MT/NL/PT/ES/SE

UK 22-May-07

Delfarma 15-Aug-07 Velcade 3.5mg Powder for solution for injection


PL 9-Oct-07

CC Pharma 07-Feb-07 Ventavis 10µg/ml Nebuliser solution

300 NO DE 27-Feb-07

Pharma Gerke 27-Dec-06 Ventavis 10µg/ml Nebuliser solution

300 AT/BE/FR/GR/IT/NL/NO/PT/UK

DE 8-Mar-07

CC Pharma 02-Feb-07 Vfend 200mg Tablets 30 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 4-Apr-07

Orifarm AB 23-Feb-07 Vfend 200mg Powder for solution for infusion

1 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LU/MT/NL/NO/PT/ES/UK

SE 15-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 133/153

PCO Ltd 13-Jun-07 Vfend 200mg Tablets 30 AT/BE/CY/DK/FR/DE/ GR/IT/LU/MT/NL/PT/ES/SE/UK

UK 14-Dec-07

Pharma Westen 05-Jul-07 Vfend 200mg Tablets 30 AT/BE/DK/FI/FR/GR/IE/IS/IT/LU/NL/NO/PT/ES/SE/UK

DE 23-Oct-07

CC Pharma 10-Aug-07 Vfend 50mg Tablets 30 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 5-Nov-07

PCO Ltd 13-Jun-07 Vfend 50mg Tablets 30 AT/BE/CY/DK/FR/DE/ GR/IT/LU/MT/NL/PT/ES/SE/UK

UK 14-Dec-07

B&S Healthcare 05-Feb-07 Viagra 100mg Film-coated tablets


UK/IE 26-Apr-07



UK/IE 26-Apr-07

CC Pharma 19-Jan-07 Viagra 100mg Film-coated tablets


DE 12-Jul-07

Euroregistratie BV 27-Nov-06 Viagra 100mg Film-coated tablets


NL 8-Feb-07

Kohlpharma 31-Jul-06 Viagra 100mg Film-coated tablets

4 AT/BE/FR/GR/IE/IT/NL/ NO/ES/SE/UK

DE 13-Feb-07

Orifarm AB 08-Oct-03 Viagra 100mg Film-coated tablets

4 AT/BE/FI/FR/DE/DK/GR/IE/IT/LU/NL/PT/ES/UK

SE 24-Apr-07



SE 24-Apr-07

Orifarm OY 11-May-07 Viagra 100mg Film-coated tablets


FI 20-Aug-07



FI 20-Aug-07



FI 20-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 134/153

SRL Pharmaceuticals

09-May-06 Viagra 100mg Film-coated tablets


UK 12-Jul-07

Fisher Farma 19-Dec-06 Viagra 100mg Film-coated tablets


NL 30-Jan-07



NL 8-Feb-07



NL 30-Jan-07

G-Pharma 19-Oct-06 Viagra 25mg Film-coated tablets


UK 9-May-07

G-Pharma 19-Oct-06 Viagra 25mg Film-coated tablets


UK 9-May-07



SE 24-Apr-07



SE 24-Apr-07

Paranova Oy 04-Apr-07 Viagra 25mg Film-coated tablets

4 BE/GR/IE/PT/UK FI 21-May-07



SRL Pharmaceuticals

09-May-06 Viagra 25mg Film-coated tablets


UK 12-Jul-07



UK/IE 26-Apr-07



UK/IE 26-Apr-07

BR Lewis 15-Dec-06 Viagra 50mg Film-coated tablets


UK/IE/MT 26-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 135/153

BR Lewis 15-Mar-07 Viagra 50mg Film-coated tablets


UK/IE/MT 16-May-07

Dowelhurst Ltd 18-Apr-05 Viagra 50mg Film-coated tablets


UK 10-Apr-07



NL 8-Feb-07



NL 30-Jan-07

Ginova 16-Aug-06 Viagra 50mg Film-coated tablets


UK 18-Jul-07

Ginova 16-Aug-06 Viagra 50mg Film-coated tablets


UK 18-Jul-07

G-Pharma 30-Jul-07 Viagra 50mg Film-coated tablets


UK 6-Aug-07

Munro Wholesale Ltd

12-Dec-05 Viagra 50mg Film-coated tablets


UK 9-Jan-07

Munro Wholesale Ltd

12-Dec-05 Viagra 50mg Film-coated tablets


UK 9-Jan-07



SE 24-Apr-07



SE 24-Apr-07



FI 30-May-07

EMEA/311899/2008 © EMEA 2008 Page 136/153



FI 30-May-07



FI 30-May-07

Paranova AB 30-May-07 Viagra 50mg Film-coated tablets

4 BE/GR SE 30-Jul-07

Paranova AB 30-May-07 Viagra 50mg Film-coated tablets

12 BE/GR/PT SE 30-Jul-07

Paranova AS 22-Dec-06 Viagra 50mg Film-coated tablets

4 AT/BE/FI/FR/DE/GR/IS/ IE/IT/NL/NO/PT/ES/SE/UK

DK 26-Apr-07







SRL Pharmaceuticals

25-Oct-05 Viagra 50mg Film-coated tablets

4 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK 19-Mar-07

Delphi BV 03-Nov-06 Viramune 200mg Tablets 60 AT/BE/FR/DE/GR/IE/IT/ PT/ES/UK

NL 15-May-07

Pharma Gerke 06-Mar-06 Viramune 200mg Tablets 60 NO DE 7-May-07

Pharma Westen 09-Jan-06 Viramune 200mg Tablets 60 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 11-Oct-07

Pharma Westen 09-Jan-06 Viramune 200mg Tablets 120 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 11-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 137/153

Delfarma 06-Aug-07 Viread 245mg Film-coated tablets


PL 12-Dec-07

Delphi BV 27-Dec-06 Viread 245mg Film-coated tablets


NL 5-Mar-07

Emra-Med 27-Sep-07 Viread 245mg Film-coated tablets


DE 29-Nov-07

Medico Pharm 30-Oct-07 Viread 245mg Film-coated tablets

30 AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/NO/PT/ES/SE/UK

DE 7-Dec-07

Orifarm AB 19-Jan-07 Viread 245mg Film-coated tablets


SE 8-May-07

Orifarm AS 19-Jan-07 Viread 245mg Film-coated tablets


DK 8-May-07

Orifarm OY 19-Jan-07 Viread 245mg Film-coated tablets


FI 8-May-07

Paranova AS 05-Mar-07 Viread 245mg Film-coated tablets

30 AT/FI/FR/DE/GR/IT/NL/ NO/ES/SE/UK

DK 1-Aug-07

Paranova OY 07-Mar-07 Viread 245mg Film-coated tablets

30 CZ/FR/IT FI 7-Aug-07

Medico Pharm 17-Jan-07 Visudyne 15mg Powder for solution for infusion


DE 27-Mar-07

Pharma Gerke 09-Nov-06 Visudyne 15mg Powder for solution for infusion

1 NO DE 24-May-07

Ivax AB 09-Jan-07 Xagrid 0.5mg Hard capsules 100 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/PT/ES/UK

SE 30-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 138/153

Orifarm AB 29-Mar-07 Xagrid 0.5mg Hard capsules 100 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

SE 16-Apr-07

Qdoxx Pharma AB 27-Dec-06 Xagrid 0.5mg Hard capsules 100 GR SE 22-Mar-07

Euroregistratie BV 14-Nov-07 Xeloda 500mg Film-coated tablets


NL 18-Dec-07


31-May-07 Xeloda 500mg Film-coated tablets


NL 26-Sep-07

PCO Ltd 01-Dec-06 Xeloda 500mg Film-coated tablets


UK/IE 30-Nov-07

Orifarm OY 19-Jan-07 Xenical 120mg Hard capsules 42 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE/UK

FI 26-Feb-07

Orifarm OY 19-Jan-07 Xenical 120mg Hard capsules 84 AT/BE/CY/DK/FR/DE/ GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE/UK

FI 26-Feb-07

Pharma Westen 25-Jun-07 Xenical 120mg Hard capsules 42 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 18-Sep-07

Pharma Westen 25-Jun-07 Xenical 120mg Hard capsules 84 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 18-Sep-07

G-Pharma 21-Nov-06 Xeristar 30mg Hard gastro-resistant capsules


UK 20-Feb-07

Intercare 06-Sep-07 Xeristar 30mg Hard gastro-resistant capsules


UK/IE 25-Sep-07

Orifarm AS 04-Jan-07 Xeristar 30mg Hard gastro-resistant capsules

28 AT/BE/CY/DE/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/UK

DK 24-Sep-07

Intercare 06-Sep-07 Xeristar 60mg Hard gastro-resistant capsules


UK/IE 25-Sep-07

EMEA/311899/2008 © EMEA 2008 Page 139/153

AxiCorp Pharma 24-Jul-06 Zeffix 100mg Film-coated tablets


DE 9-May-07

Chemilines Ltd 17-Nov-06 Zeffix 100mg Film-coated tablets

28 AT/BE/CY/DK/FI/FR/DE GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE

UK 1-Jun-07

G-Pharma 26-Jul-07 Zeffix 100mg Film-coated tablets


UK 10-Aug-07

Mediport 21-May-07 Zeffix 100mg Film-coated tablets


UK 4-Jul-07

Pharma Gerke 19-Feb-07 Zeffix 100mg Film-coated tablets


DE 26-Jun-07

Pharma Westen 08-May-07 Zeffix 100mg Film-coated tablets


DE 26-Jun-07

Eureco-Pharma B.V.

08-May-06 Zeffix 100mg Film-coated tablets

84 AT/UK NL 13-Mar-07

Kohlpharma 13-Jul-07 Zerit 30mg Hard capsules 56 AT/BE/FR/GR/IE/IT/NL/NO/PT/ES/SE/UK

DE 21-Aug-07

Pharma Westen 08-Jun-07 Zerit 40mg Hard capsules 56 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 11-Sep-07

Beragena 23-May-07 Ziagen 300mg Film-coated tablets


DE 20-Nov-07


21-Mar-07 Ziagen 300mg Film-coated tablets


NL 23-Apr-07

Pharma Gerke 29-Jan-07 Ziagen 300mg Film-coated tablets


DE 18-Apr-07

CC Pharma 19-Dec-06 Ziagen 300mg Film-coated tablets


DE 23-Apr-07

Qdoxx Pharma AB 06-Dec-06 Zometa 4mg Concentrate for solution for infusion

1 GR SE 14-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 140/153

Cross Pharma AB 12-Dec-06 Zometa 4mg Concentrate for solution for infusion

1 DE/GR/UK SE 14-Feb-07


03-Sep-07 Zometa 4mg Concentrate for solution for infusion

1 AT/BE/DK/FI/FR/GR/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DE 12-Oct-07

Mediport 15-Jun-07 Zonegran 100mg Hard capsules 56 AT/BE/FR/DE/GR/IT/MT/NL/PT/ES

UK 1-Oct-07

Emra-Med 27-Sep-07 Zonegran 25mg Hard capsules 28 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DE 4-Dec-07

Intercare 18-Jul-07 Zonegran 25mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/LU/MT/NL/PT/ES/ SE

UK/IE 7-Aug-07

Kohlpharma 14-May-07 Zonegran 25mg Hard capsules 28 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 14-Jun-07


UK 1-Oct-07


10-Aug-07 Zonegran 25mg Hard capsules 14 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PL/PT/SK/SI/ES/SE

UK 29-Aug-07

Emra-Med 27-Sep-07 Zonegran 50mg Hard capsules 28 AT/BE/CY/DK/FI/FR/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE/UK

DE 4-Dec-07

Intercare 06-Sep-07 Zonegran 50mg Hard capsules 28 AT/BE/CY/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK/IE 18-Sep-07

Kohlpharma 23-Apr-07 Zonegran 50mg Hard capsules 28 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 21-May-07


UK 1-Oct-07

Pharma Westen 20-Nov-06 Zonegran 50mg Hard capsules 28 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/UK

DE 11-Jul-07

EMEA/311899/2008 © EMEA 2008 Page 141/153


10-Aug-07 Zonegran 50mg Hard capsules 28 AT/BE/CY/CZ/DK/EE/FI/FR/DE/GR/HU/IS/IE/IT/LV/LI/LT/LU/MT/NL/ NO/PL/PT/SK/SI/ES/SE

UK 29-Aug-07

Lexon 27-Mar-07 Zonegran 25mg Hard capsules 14 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE

UK 17-Apr-07

Lexon 27-Mar-07 Zonegran 50mg Hard capsules 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/ NL/NO/PT/ES/SE

UK 17-Apr-07

Apothekamed 25-May-06 Zyprexa 10mg Coated tablets 28 AT/BE/ES/FR/IT/NL/PT DE 6-Jun-07




AxiCorp Pharma 13-Jul-07 Zyprexa 10mg Coated tablets 35 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 15-Aug-07


DE 15-Aug-07

Beragena 13-Jul-07 Zyprexa 10mg Coated tablets 35 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 12-Dec-07


DE 12-Dec-07

CC Pharma 25-Jun-07 Zyprexa 10mg Coated tablets 35 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 25-Sep-07


DE 25-Sep-07

Delphi BV 03-Nov-06 Zyprexa 10mg Coated tablets 28 AT/BE/FR/GR/DE/IE/IT/ PT/ES/UK

NL 4-May-07

EMEA/311899/2008 © EMEA 2008 Page 142/153

Docpharm 05-Jul-07 Zyprexa 10mg Coated tablets 35 AT/BE/DK/FI/FR/GR/IE/IT/LU/MT/NL/NO/PT/ES/UK

DE 27-Nov-07


DE 27-Nov-07

Dowelhurst Ltd 29-Dec-06 Zyprexa 10mg Coated tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 19-Jun-07

Ginova 15-Feb-07 Zyprexa 10mg Coated tablets 28 AT/BE/CY/DK/FR/DE/ GR/IE/IT/LU/MT/NL/NO/PT/ES/SE

UK 20-Apr-07

G-Pharma 21-Feb-07 Zyprexa 10mg Coated tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 29-Mar-07

Kohlpharma 15-Jun-07 Zyprexa 10mg Coated tablets 35 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 17-Aug-07


DE 17-Aug-07

Medico Pharm 23-Mar-07 Zyprexa 10mg Coated tablets 56 AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/PT/ES/SE/UK

DE 21-Aug-07

Medico Pharm 10-May-07 Zyprexa 10mg Coated tablets 35 AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/PT/ES/SE/UK

DE 6-Nov-07

Medico Pharm 10-May-07 Zyprexa 10mg Coated tablets 70 AT/BE/CY/DK/FI/FR/GR/IE/IT/LU/MT/NL/PT/ES/SE/UK

DE 6-Nov-07

Parallell Pharma AB 06-Oct-06 Zyprexa 10mg Coated tablets 28 ES SE 11-Apr-07

Pharma Gerke 31-Mar-06 Zyprexa 10mg Coated tablets 28 NO DE 12-Jul-07

Pharma Westen 26-Apr-07 Zyprexa 10mg Coated tablets 35 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 21-May-07

EMEA/311899/2008 © EMEA 2008 Page 143/153


DE 21-May-07

SinGad Pharma ApS

25-May-06 Zyprexa 10mg Coated tablets 56 ES DK 31-Aug-07

Veron Pharma 02-May-07 Zyprexa 10mg Coated tablets 35 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 4-Sep-07


DE 4-Sep-07


DE 15-Aug-07


DE 15-Aug-07

Beragena 13-Jul-07 Zyprexa 15mg Coated tablets 35 AT/BE/FR/GR/IT/NL/PT/ES/UK

DE 12-Dec-07


DE 12-Dec-07

Euroregistratie BV 23-Oct-07 Zyprexa 15mg Coated tablets 28 AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 18-Dec-07


DE 30-Jul-07


DE 30-Jul-07

PCO Ltd 01-Dec-06 Zyprexa 15mg Coated tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IT/LU/MT/NL/ NO/PT/ES/SE/UK

UK/IE 30-Mar-07


DE 21-May-07


DE 21-May-07

EMEA/311899/2008 © EMEA 2008 Page 144/153

SRL Pharmaceuticals

19-May-06 Zyprexa 15mg Coated tablets 28 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/NL/PT/ES/SE

UK 13-Mar-07

Apothekamed 25-May-06 Zyprexa 2.5mg Coated tablets 28 AT/ES/IT DE 6-Jun-07

Apothekamed 25-May-06 Zyprexa 2.5mg Coated tablets 35 AT/ES/IT DE 6-Jun-07

Beragena 13-Jul-07 Zyprexa 2.5mg Coated tablets 35 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 12-Dec-07


DE 12-Dec-07

CC Pharma 25-Jun-07 Zyprexa 2.5mg Coated tablets 35 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 25-Sep-07


DE 25-Sep-07

Delphi BV 03-Nov-06 Zyprexa 2.5mg Coated tablets 28 AT/BE/FR/GR/DE/IE/IT/ PT/ES/UK

NL 4-May-07

Emra-Med 26-Mar-07 Zyprexa 2.5mg Coated tablets 28 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/PT/ES/SE/UK

DE 17-Jul-07

G-Pharma 13-Dec-06 Zyprexa 2.5mg Coated tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 23-May-07

Kohlpharma 15-Jun-07 Zyprexa 2.5mg Coated tablets 35 AT/BE/FR/GR/IE/IT/NL/ NO/PT/ES/SE/UK

DE 26-Sep-07


DE 26-Sep-07

Pharma Westen 27-Apr-07 Zyprexa 2.5mg Coated tablets 28 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 21-May-07

Pharma Westen 27-Apr-07 Zyprexa 2.5mg Coated tablets 35 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 21-May-07

Beragena 01-Feb-07 Zyprexa 20mg Coated tablets 28 AT/BE/FR/GR/IT/NL/PT/ ES/UK

DE 25-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 145/153


DE 12-Dec-07


DE 12-Dec-07

Emra-Med 04-Aug-06 Zyprexa 20mg Coated tablets 28 NL DE 28-Mar-07

Euroregistratie BV 23-Oct-07 Zyprexa 20mg Coated tablets 28 AT/BE/FR/DE/GR/IE/IT/ NO/PT/ES/UK

NL 18-Dec-07


DE 16-Oct-07

Paranova AS 13-Jun-07 Zyprexa 20mg Coated tablets 28 DE/NL/NO/UK DK 6-Jul-07

Pharma Westen 21-May-07 Zyprexa 20mg Coated tablets 35 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 7-Sep-07

Pharma Westen 12-Feb-07 Zyprexa 20mg Coated tablets 28 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 7-Sep-07


DE 15-Aug-07


DE 15-Aug-07


DE 12-Dec-07


DE 12-Dec-07


DE 25-Sep-07


DE 25-Sep-07

Delphi BV 03-Nov-06 Zyprexa 5mg Coated tablets 28 AT/BE/FR/GR/DE/IE/IT/ PT/ES/UK

NL 4-May-07

EMEA/311899/2008 © EMEA 2008 Page 146/153


DE 27-Nov-07


DE 27-Nov-07


DE 30-Jul-07


DE 30-Jul-07

N.G. Ltd 19-Mar-07 Zyprexa 5mg Coated tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 20-Jun-07

Pharma Gerke 09-Oct-06 Zyprexa 5mg Coated tablets 56 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 8-May-07


DE 21-May-07


DE 21-May-07

SinGad Pharma ApS

25-May-06 Zyprexa 5mg Coated tablets 28 ES DK 31-Aug-07


DE 4-Sep-07


DE 4-Sep-07

Apothekamed 25-May-06 Zyprexa 7.5mg Coated tablets 56 AT/BE/ES/FR/IT/NL/PT DE 6-Jun-07

Apothekamed 25-May-06 Zyprexa 7.5mg Coated tablets 70 AT/BE/ES/FR/IT/NL/PT DE 6-Jun-07

AxiCorp Pharma 13-Jul-07 Zyprexa 7.5mg Coated tablets 35 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 15-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 147/153


DE 12-Dec-07


DE 12-Dec-07


DE 25-Sep-07

GenPlus Ltd 30-Jun-06 Zyprexa 7.5mg Coated tablets 56 AT/BE/DK/FI/FR/DE/GR/IE/IT/LU/MT/NL/PT/ES/SE

UK 7-Sep-07

G-Pharma 09-Mar-07 Zyprexa 7.5mg Coated tablets 28 AT/BE/CY/DK/FI/FR/DE/GR/IS/IE/IT/LI/LU/MT/NL/NO/PT/ES/SE

UK 26-Mar-07


DE 26-Sep-07

Pharma Gerke 06-Sep-06 Zyprexa 7.5mg Coated tablets 56 AT/BE/FR/GR/IT/NO/PT/ ES/UK

DE 11-May-07

Pharma Westen 26-Apr-07 Zyprexa 7.5mg Coated tablets 70 AT/BE/DK/FI/FR/GR/IE/IT/LU/NL/NO/PT/ES/SE/UK

DE 21-May-07

AxiCorp Pharma 13-Jul-07 Zyprexa Velotab

10mg Orodispersible tablets


DE 15-Aug-07




DE 15-Aug-07

B&S Healthcare 30-Nov-06 Zyprexa Velotab


56 AT/BE/FR/DE/GR/IT/PT/ ES

UK/IE 15-Jan-07

Beragena 13-Jul-07 Zyprexa Velotab



DE 5-Dec-07




DE 5-Dec-07

Beragena 29-Aug-06 Zyprexa Velotab



DE 5-Dec-07

CC Pharma 17-Jan-07 Zyprexa Velotab



DE 13-Apr-07

EMEA/311899/2008 © EMEA 2008 Page 148/153

CC Pharma 20-Feb-07 Zyprexa Velotab



DE 13-Apr-07

CC Pharma 03-Jul-07 Zyprexa Velotab



DE 28-Sep-07

CC Pharma 03-Jul-07 Zyprexa Velotab



DE 28-Sep-07

Chemilines Ltd 22-Sep-06 Zyprexa Velotab



UK 30-Apr-07

Chemilines Ltd 22-Sep-06 Zyprexa Velotab



UK 30-Apr-07

Cross Pharma AB 21-Sep-06 Zyprexa Velotab


28 BE/FR/IT/NL/ES/UK SE 18-Apr-07

Delphi BV 03-Nov-06 Zyprexa Velotab


28 AT/BE/FR/GR/DE/IE/IT/ PT/ES/UK

NL 4-May-07

Docpharm 17-Aug-07 Zyprexa Velotab



DE 13-Nov-07




DE 13-Nov-07




DE 13-Nov-07




DE 13-Nov-07

GenPlus Ltd 09-Aug-07 Zyprexa Velotab



UK 19-Nov-07

G-Pharma 07-Nov-06 Zyprexa Velotab



UK 2-Apr-07

Interport 15-Feb-07 Zyprexa Velotab



UK 28-Jun-07

EMEA/311899/2008 © EMEA 2008 Page 149/153

Kohlpharma 15-Jun-07 Zyprexa Velotab



DE 16-Aug-07




DE 16-Aug-07

Medartuum AB 24-Jul-06 Zyprexa Velotab



SE 5-Jan-07


05-Jul-06 Zyprexa Velotab



UK 9-Jul-07

Pharma Westen 11-Jun-07 Zyprexa Velotab



DE 17-Sep-07




DE 17-Sep-07

Stephar (UK) Ltd 02-Aug-06 Zyprexa Velotab



UK 21-Mar-07


22-Nov-06 Zyprexa Velotab



UK 24-May-07

B&S Healthcare 06-Dec-06 Zyprexa Velotab


28 AT/BE/FR/DE/GR/IT/PT/ ES

UK/IE 15-Jan-07




DE 5-Dec-07




DE 13-Apr-07




DE 13-Apr-07

CC Pharma 10-Sep-07 Zyprexa Velotab



DE 3-Oct-07




DE 3-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 150/153

Emra-Med 30-Aug-06 Zyprexa Velotab


28 NL DE 15-May-07




DE 26-Sep-07




DE 26-Sep-07




SE 5-Jan-07

Orifarm AS 03-Jan-07 Zyprexa Velotab



DK 23-Jul-07

PCO Ltd 01-Dec-06 Zyprexa Velotab


28 AT/BE/DK/FI/FR/DE/GR/IT/LU/NL/PT/ES/SE/UK

UK/IE 30-Mar-07




DE 17-Sep-07



70 AT/BE/DK/FI/FR/GR/IS/ IE/IT/LU/NL/NO/PT/ES/ SE/UK

DE 17-Sep-07

Cross Pharma AB 18-Dec-06 Zyprexa Velotab


28 GR/NO/UK SE 18-Apr-07

B&S Healthcare 13-Mar-07 Zyprexa Velotab


28 AT/BE/BG/CZ/EE/FR/DE/GR/HU/IT/LV/LT/NL/ PL/PT/RO/SK/SI/ES

UK/IE 23-Apr-07




DE 5-Dec-07




DE 13-Apr-07




DE 13-Apr-07




DE 3-Oct-07




DE 3-Oct-07

EMEA/311899/2008 © EMEA 2008 Page 151/153

Intercare 05-Jan-07 Zyprexa Velotab



UK/IE 27-Apr-07

Kohlpharma 12-Feb-07 Zyprexa Velotab



DE 30-Mar-07

Kohlpharma 28-Dec-06 Zyprexa Velotab



DE 30-Mar-07




DE 26-Sep-07




DE 26-Sep-07




SE 5-Jan-07


05-Jan-07 Zyprexa Velotab


28 AT/BE/CY/FR/DE/GR/IE/IT/MT/NL/NO/PT/ES

UK 26-Jul-07

Paranova AS 02-Jan-07 Zyprexa Velotab


28 DE/GR/FI/NL/NO/UK DK 21-Sep-07

Pharma Gerke 11-Jan-07 Zyprexa Velotab


28 AT/BE/CZ/FR/GR/IT/NO/PT/ES/UK

DE 26-Jul-07




DE 17-Sep-07




DE 17-Sep-07


22-Nov-06 Zyprexa Velotab



UK 24-May-07




DE 15-Aug-07

EMEA/311899/2008 © EMEA 2008 Page 152/153




DE 15-Aug-07




DE 5-Dec-07




DE 13-Apr-07




DE 13-Apr-07




DE 13-Nov-07




DE 13-Nov-07




DE 13-Nov-07




DE 13-Nov-07

EuroPharma DK 29-Aug-06 Zyprexa Velotab


28 GR DK 11-Jun-07

GenPlus Ltd 09-Aug-07 Zyprexa Velotab



UK 21-Sep-07

G-Pharma 10-Jan-07 Zyprexa Velotab



UK 15-May-07




DE 16-Aug-07




DE 16-Aug-07




SE 5-Jan-07

EMEA/311899/2008 © EMEA 2008 Page 153/153




DE 17-Sep-07




DE 17-Sep-07

Stephar (UK) Ltd 08-Jun-06 Zyprexa Velotab



UK 21-Mar-07

Veron Pharma 31-May-07 Zyprexa Velotab



DE 14-Sep-07

Veron Pharma 31-May-07 Zyprexa Velotab



DE 14-Sep-07

Documents

Initial Notices for Parallel Distribution – 2007 · European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London,