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Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000
© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
12 November 2020 EMA/698316/2020 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: Fluconazole PSUSA/00001404/202003
Procedure no.: PSUSA/00001404/202003
List of nationally authorised medicinal products EMA/698316/2020 Page 2/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ELAZOR 200 mg capsule rigide
not available 027268097 ALFASIGMA S.P.A. IT
ELAZOR 150 mg capsule rigide
not available 027268022 ALFASIGMA S.P.A. IT
ELAZOR 100 mg capsule rigide
not available 027268046 ALFASIGMA S.P.A. IT
ELAZOR 50 mg capsule rigide
not available 027268010 ALFASIGMA S.P.A. IT
Fluconazol PUREN 150 mg Hartkapseln
not available 96846.00.00 PUREN PHARMA GMBH & CO. KG
DE
Fluconazol Accord 150 mg Hartkapseln
SE/H/1063/003 84492.00.00 ACCORD HEALTHCARE B.V. DE
Fluconazol Kern Pharma 150 mg cápsulas duras
not available 59.059 KERN PHARMA, S.L. ES
Fluconazole 50mg Capsules
not available PL 21880/0134 MEDREICH PLC UK
Fluconazole 150mg Capsules
not available PL 21880/0135 MEDREICH PLC UK
List of nationally authorised medicinal products EMA/698316/2020 Page 3/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fluconazole 200mg Capsules
not available PL 21880/0136 MEDREICH PLC UK
Diflucan 200 mg cápsulas DE/H/3456/004 2074680 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen
DE/H/3456/005 BE160422 PFIZER S.A. (BELGIUM) BE
Diflucan 100 mg Hartkapseln
DE/H/3456/002 BE253504 PFIZER S.A. (BELGIUM) BE
Diflucan 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen
DE/H/3456/005 2003097827 PFIZER S.A. (BELGIUM) LU
Diflucan 2 mg/ml Infusionslösung
DE/H/3456/006 BE305417 PFIZER S.A. (BELGIUM) BE
Diflucan 2 mg/ml solution pour perfusion
DE/H/3456/006 BE444035 PFIZER S.A. (BELGIUM) BE
Diflucan 2 mg/ml Infusionslösung
DE/H/3456/006 BE305426 PFIZER S.A. (BELGIUM) BE
Diflucan 150 mg cápsulas DE/H/3456/003 8692822 LABORATÓRIOS PFIZER, LDA. PT
List of nationally authorised medicinal products EMA/698316/2020 Page 4/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 2 mg/ml oplossing voor infusie
DE/H/3456/006 BE192945 PFIZER S.A. (BELGIUM) BE
Diflucan 100 mg Hartkapseln
DE/H/3456/002 2003097824 PFIZER S.A. (BELGIUM) LU
Diflucan 2 mg/ml infuusioneste, liuos
DE/H/3456/006 10021 PFIZER OY FI
Diflucan, infusionsvæske, opløsning
DE/H/3456/006 13397 PFIZER APS DK
Diflucan, infusionsvæske, opløsning
DE/H/3456/006 13397 PFIZER APS DK
Diflucan 150 mg, kõvakapslid
DE/H/3456/003 104595 PFIZER EUROPE MA EEIG EE
Diflucan, kapsler, hårde DE/H/3456/001 13091 PFIZER APS DK
Diflucan, pulver til oral suspension
DE/H/3456/005 14254 PFIZER APS DK
Diflucan, infusionsvæske, opløsning
DE/H/3456/006 13397 PFIZER APS DK
List of nationally authorised medicinal products EMA/698316/2020 Page 5/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 100 mg tvrdé tobolky
DE/H/3456/002 26/121/91 – B/C PFIZER, SPOL. S R.O. CZ
Diflucan 50 mg tvrdé tobolky
DE/H/3456/001 26/121/91 – A/C PFIZER, SPOL. S R.O. CZ
Diflucan 50 mg kovat kapselit
DE/H/3456/001 10044 PFIZER OY FI
Diflucan 150 mg kovat kapselit
DE/H/3456/003 10020 PFIZER OY FI
Diflucan, kapsler, hårde DE/H/3456/004 13398 PFIZER APS DK
Diflucan, kapsler, hårde DE/H/3456/003 13092 PFIZER APS DK
Diflucan 100 mg kovat kapselit
DE/H/3456/002 10045 PFIZER OY FI
Diflucan 40 mg/ml poudre pour suspension buvable
DE/H/3456/008 BE160413 PFIZER S.A. (BELGIUM) BE
Diflucan 40 mg/ml jauhe oraalisuspensiota varten
DE/H/3456/008 11543 PFIZER OY FI
List of nationally authorised medicinal products EMA/698316/2020 Page 6/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg tvrdé tobolky
DE/H/3456/003 26/121/91 – C/C PFIZER, SPOL. S R.O. CZ
Diflucan 2 mg/ml innrennslislyf, lausn
DE/H/3456/006 890097 PFIZER APS IS
Diflucan 2 mg/ml innrennslislyf, lausn
DE/H/3456/006 890097 PFIZER APS IS
Diflucan 2 mg/ml innrennslislyf, lausn
DE/H/3456/006 890097 PFIZER APS IS
Diflucan 2 mg/ml innrennslislyf, lausn
DE/H/3456/006 890097 PFIZER APS IS
TRIFLUCAN 50 mg/5 ml, poudre pour suspension buvable
DE/H/3456/005 34009 335 470 9 7 PFIZER HOLDING FRANCE FR
Fungustatin 2 mg/ml διάλυμα για έγχυση
DE/H/3456/006 13275 PFIZER HELLAS, A.E. CY
Fungustatin 2 mg/ml διάλυμα για έγχυση
DE/H/3456/006 13275 PFIZER HELLAS, A.E. CY
Fungustatin 2 mg/ml διάλυμα για έγχυση
DE/H/3456/006 13275 PFIZER HELLAS, A.E. CY
List of nationally authorised medicinal products EMA/698316/2020 Page 7/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fungustatin 40 mg/ml κόνις για πόσιμο εναιώρημα
DE/H/3456/008 41150/10/31-05-2011 PFIZER HELLAS, A.E. GR
Fungustatin 2 mg/ml διάλυμα για έγχυση
DE/H/3456/006 13275 PFIZER HELLAS, A.E. CY
Fungustatin 10 mg/ml κόνις για πόσιμο εναιώρημα
DE/H/3456/005 41148/10/31-05-2011 PFIZER HELLAS, A.E. GR
Fungustatin 150 mg σκληρά καψάκια
DE/H/3456/003 13273 PFIZER HELLAS, A.E. CY
Fungustatin 2 mg/ml διάλυμα για έγχυση
DE/H/3456/006 71799/30-9-2016 PFIZER HELLAS, A.E. GR
Fungustatin 2 mg/ml διάλυμα για έγχυση
DE/H/3456/006 71799/30-9-2016 PFIZER HELLAS, A.E. GR
Fungustatin 2 mg/ml διάλυμα για έγχυση
DE/H/3456/006 71799/30-9-2016 PFIZER HELLAS, A.E. GR
Fungustatin 2 mg/ml διάλυμα για έγχυση
DE/H/3456/006 71799/30-9-2016 PFIZER HELLAS, A.E. GR
Fungustatin 100 mg σκληρά καψάκια
DE/H/3456/002 41145/10/31-05-2011 PFIZER HELLAS, A.E. GR
List of nationally authorised medicinal products EMA/698316/2020 Page 8/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fungustatin 50 mg σκληρά καψάκια
DE/H/3456/001 41144/10/31-05-2011 PFIZER HELLAS, A.E. GR
Fungustatin 200 mg σκληρά καψάκια
DE/H/3456/004 41147/10/31-05-2011 PFIZER HELLAS, A.E. GR
Fungustatin 150 mg σκληρά καψάκια
DE/H/3456/003 41146/10/31-05-2011 PFIZER HELLAS, A.E. GR
Diflucan 200 mg hard capsules
DE/H/3456/004 PL 00057/0317 PFIZER LIMITED UK
Diflucan 50 mg hard capsules
DE/H/3456/001 PL 00057/0289 PFIZER LIMITED UK
Diflucan 40 mg/ml powder for oral suspension
DE/H/3456/008 PL 00057/0344 PFIZER LIMITED UK
Diflucan 2 mg/ml solution for infusion
DE/H/3456/006 PL 00057/0315 PFIZER LIMITED UK
Diflucan 10 mg/ml powder for oral suspension
DE/H/3456/005 PL 00057/0343 PFIZER LIMITED UK
Diflucan 150 mg hard capsules
DE/H/3456/003 PL 00057/0290 PFIZER LIMITED UK
List of nationally authorised medicinal products EMA/698316/2020 Page 9/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/19 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/15 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/17 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/21 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/28 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/27 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/25 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/07 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/31 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 10/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/02 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/22 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/24 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/04 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/27 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/30 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/13 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/12 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/23 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 11/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/20 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/09 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/03 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/28 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/34 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/10 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/34 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/06 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/33 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 12/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/09 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/26 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/25 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/32 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/17 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/18 PFIZER EUROPE MA EEIG RO
Diflucan 100 mg cápsulas duras.
DE/H/3456/002 58.804 VINCIFARMA S.A. ES
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/08 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/14 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 13/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/22 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/06 PFIZER EUROPE MA EEIG RO
Diflucan 10 mg/ml polvo para suspensión oral
DE/H/3456/005 59.672 VINCIFARMA S.A. ES
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/11 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/07 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/15 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/02 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/19 PFIZER EUROPE MA EEIG RO
Diflucan 40 mg/ml polvo para suspensión oral
DE/H/3456/008 59.673 VINCIFARMA S.A. ES
List of nationally authorised medicinal products EMA/698316/2020 Page 14/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/05 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg cápsulas duras.
DE/H/3456/003 58.766 VINCIFARMA S.A. ES
Diflucan 200 mg cápsulas duras.
DE/H/3456/004 58.803 VINCIFARMA S.A. ES
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/03 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/21 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/12 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/29 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/32 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/29 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 15/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/23 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/18 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/31 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/33 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/16 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/13 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/14 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/30 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/08 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 16/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/11 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/01 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/04 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/10 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/24 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/20 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/26 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/01 PFIZER EUROPE MA EEIG RO
Diflucan 150 mg capsule DE/H/3456/003 5125/2012/05 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 17/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg hard capsules
DE/H/3456/001 PA 0822/211/001 PFIZER HEALTHCARE IRELAND
IE
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/007 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/009 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/016 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/018 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/001 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/017 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/006 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/008 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/698316/2020 Page 18/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/047 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/051 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/013 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/014 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/020 PFIZER EUROPE MA EEIG LT
Дифлукан 150 mg твърди капсули
DE/H/3456/003 20010472 PFIZER EUROPE MA EEIG BG
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/011 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/012 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/019 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/698316/2020 Page 19/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/015 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/010 PFIZER EUROPE MA EEIG LT
DIFLUCAN 50 mg kietosios kapsulės
DE/H/3456/001 LT/1/96/1923/005 PFIZER EUROPE MA EEIG LT
Дифлукан 2 mg/ml инфузионен разтвор
DE/H/3456/006 20010470 PFIZER EUROPE MA EEIG BG
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/003 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/037 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/050 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/045 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/048 PFIZER EUROPE MA EEIG LT
List of nationally authorised medicinal products EMA/698316/2020 Page 20/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/043 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/038 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/042 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/004 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/039 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/046 PFIZER EUROPE MA EEIG LT
Дифлукан 2 mg/ml инфузионен разтвор
DE/H/3456/006 20010470 PFIZER EUROPE MA EEIG BG
Дифлукан 2 mg/ml инфузионен разтвор
DE/H/3456/006 20010470 PFIZER EUROPE MA EEIG BG
Дифлукан 2 mg/ml инфузионен разтвор
DE/H/3456/006 20010470 PFIZER EUROPE MA EEIG BG
List of nationally authorised medicinal products EMA/698316/2020 Page 21/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/040 PFIZER EUROPE MA EEIG LT
Diflucan 150 mg kemény kapszula
DE/H/3456/003 OGYI-T-1550/05 PFIZER KFT. HU
Diflucan 150 mg kemény kapszula
DE/H/3456/003 OGYI-T-1550/04 PFIZER KFT. HU
Diflucan 100 mg kemény kapszula
DE/H/3456/002 OGYI-T-1550/02 PFIZER KFT. HU
Diflucan 150 mg kemény kapszula
DE/H/3456/003 OGYI-T-1550/03 PFIZER KFT. HU
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/044 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/041 PFIZER EUROPE MA EEIG LT
DIFLUCAN 150 mg kietosios kapsulės
DE/H/3456/003 LT/1/96/1923/049 PFIZER EUROPE MA EEIG LT
Diflucan 200 mg kemény kapszula
DE/H/3456/004 OGYI-T-1550/06 PFIZER KFT. HU
List of nationally authorised medicinal products EMA/698316/2020 Page 22/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg kemény kapszula
DE/H/3456/001 OGYI-T-1550/01 PFIZER KFT. HU
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/008 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/013 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/017 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/002 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/015 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/032 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/012 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/030 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 23/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/033 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/014 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/026 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/020 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/048 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/031 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/037 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/038 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/034 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 24/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/003 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/021 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/006 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/029 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/023 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/018 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/025 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg gélules DE/H/3456/001 2003097823 PFIZER S.A. (BELGIUM) LU
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/016 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 25/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 200 mg harde capsules
DE/H/3456/004 BE253513 PFIZER S.A. (BELGIUM) BE
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/024 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/035 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/022 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/001 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/027 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/004 PFIZER LUXEMBOURG SARL SI
Diflucan 200 mg gélules DE/H/3456/006 2003097826 PFIZER S.A. (BELGIUM) LU
Diflucan 2 mg/ml oplossing voor infusie
DE/H/3456/006 BE155854 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/698316/2020 Page 26/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/019 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/064 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/028 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/060 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/010 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg gélules DE/H/3456/003 2003097825 PFIZER S.A. (BELGIUM) LU
Diflucan 150 mg harde capsules
DE/H/3456/003 BE253495 PFIZER S.A. (BELGIUM) BE
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/009 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg harde capsules
DE/H/3456/001 BE253486 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/698316/2020 Page 27/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/011 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/007 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/068 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg trde kapsule
DE/H/3456/001 H/93/00473/005 PFIZER LUXEMBOURG SARL SI
TRIFLUCAN 2 mg/ml, solution pour perfusion
DE/H/3456/006 34009 374 130 0 8 PFIZER HOLDING FRANCE FR
Diflucan 200 mg kapsel, hard
DE/H/3456/004 7601 PFIZER AS NO
Diflucan 2 mg/ml infusjonsvæske, oppløsning
DE/H/3456/006 7597 PFIZER AS NO
Diflucan 2 mg/ml infusjonsvæske, oppløsning
DE/H/3456/006 7597 PFIZER AS NO
TRIFLUCAN 100 mg, gélule
DE/H/3456/002 34009 345 574 1 5 PFIZER HOLDING FRANCE FR
List of nationally authorised medicinal products EMA/698316/2020 Page 28/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
TRIFLUCAN 40 mg/ml, poudre pour suspension buvable
DE/H/3456/008 34009 335 471 5 8 PFIZER HOLDING FRANCE FR
TRIFLUCAN 200 mg, gélule
DE/H/3456/004 34009 345 575 8 3 PFIZER HOLDING FRANCE FR
TRIFLUCAN 100 mg, gélule
DE/H/3456/002 34009 332 659 3 9 PFIZER HOLDING FRANCE FR
Diflucan 150 mg kapsel, hard
DE/H/3456/003 7600 PFIZER AS NO
TRIFLUCAN 200 mg, gélule
DE/H/3456/004 34009 332 658 7 8 PFIZER HOLDING FRANCE FR
TRIFLUCAN 10 mg/ml, poudre pour suspension buvable
DE/H/3456/005 34009 335 470 9 7 PFIZER HOLDING FRANCE FR
TRIFLUCAN 2 mg/ml, solution pour perfusion
DE/H/3456/006 34009 332 661 8 9 PFIZER HOLDING FRANCE FR
FLUCONAZOLE PFIZER 150 mg, gélule
DE/H/3456/003 34009 330 553 3 2 PFIZER HOLDING FRANCE FR
TRIFLUCAN 50 mg, gélule DE/H/3456/001 34009 556 136 4 0 PFIZER HOLDING FRANCE FR
List of nationally authorised medicinal products EMA/698316/2020 Page 29/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 2 mg/ml infusjonsvæske, oppløsning
DE/H/3456/006 7597 PFIZER AS NO
Diflucan 50 mg kapsel, hard
DE/H/3456/001 7598 PFIZER AS NO
Diflucan 100 mg kapsel, hard
DE/H/3456/002 7599 PFIZER AS NO
Diflucan 2 mg/ml infusjonsvæske, oppløsning
DE/H/3456/006 7597 PFIZER AS NO
TRIFLUCAN 50 mg, gélule DE/H/3456/001 34009 330 551 0 3 PFIZER HOLDING FRANCE FR
TRIFLUCAN 2 mg/ml, solution pour perfusion
DE/H/3456/006 34009 332 660 1 1 PFIZER HOLDING FRANCE FR
TRIFLUCAN 2 mg/ml, solution pour perfusion
DE/H/3456/006 34009 374 129 2 6 PFIZER HOLDING FRANCE FR
TRIFLUCAN 2 mg/ml, solution pour perfusion
DE/H/3456/006 34009 332 663 0 1 PFIZER HOLDING FRANCE FR
TRIFLUCAN 2 mg/ml, solution pour perfusion
DE/H/3456/006 34009 332 662 4 0 PFIZER HOLDING FRANCE FR
List of nationally authorised medicinal products EMA/698316/2020 Page 30/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 200 mg cápsulas DE/H/3456/004 4571980 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 100 mg cápsulas DE/H/3456/002 2074581 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 10 mg/ml pó para suspensão oral
DE/H/3456/005 2132181 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 150 mg cápsulas DE/H/3456/003 8692830 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/098 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/081 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/088 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/092 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/082 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 31/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg cápsulas DE/H/3456/003 8797100 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 100 mg cápsulas DE/H/3456/002 4571881 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 40 mg/ml prašek za peroralno suspenzijo
DE/H/3456/008 H/93/00473/116 PFIZER LUXEMBOURG SARL SI
Diflucan 50 mg cápsulas DE/H/3456/001 8692806 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/074 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/099 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/076 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/087 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/083 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 32/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/089 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/096 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/101 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/067 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/102 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/078 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/093 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/100 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/071 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 33/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/051 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/086 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/049 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/079 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/084 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/085 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/090 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/057 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/075 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 34/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/077 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/091 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/095 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/046 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/094 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/058 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/055 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/059 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/056 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 35/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/052 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/070 PFIZER LUXEMBOURG SARL SI
Diflucan 2 mg/ml solution pour perfusion
DE/H/3456/006 2003097830 PFIZER S.A. (BELGIUM) LU
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/042 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/041 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/065 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/061 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/073 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/040 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 36/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/044 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/062 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/045 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/097 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/043 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/036 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/047 PFIZER LUXEMBOURG SARL SI
Diflucan 2 mg/ml solution pour perfusion
DE/H/3456/006 2003097831 PFIZER S.A. (BELGIUM) LU
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/039 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 37/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/080 PFIZER LUXEMBOURG SARL SI
Diflucan 40 mg/ml poudre pour suspension buvable
DE/H/3456/008 2003097828 PFIZER S.A. (BELGIUM) LU
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/054 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/050 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/053 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/072 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/063 PFIZER LUXEMBOURG SARL SI
Diflucan 100 mg trde kapsule
DE/H/3456/002 H/93/00473/066 PFIZER LUXEMBOURG SARL SI
Diflucan 150 mg trde kapsule
DE/H/3456/003 H/93/00473/069 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/698316/2020 Page 38/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan, 2 mg/ml, roztwór do infuzji
DE/H/3456/006 R/0717 PFIZER EUROPE MA EEIG PL
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/03 PFIZER EUROPE MA EEIG RO
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/01 PFIZER EUROPE MA EEIG RO
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/02 PFIZER EUROPE MA EEIG RO
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/08 PFIZER EUROPE MA EEIG RO
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/11 PFIZER EUROPE MA EEIG RO
Diflucan 10 mg/ml pulbere pentru suspensie orală
DE/H/3456/005 4067/2011/02 PFIZER EUROPE MA EEIG RO
Diflucan, 2 mg/ml, roztwór do infuzji
DE/H/3456/006 R/0717 PFIZER EUROPE MA EEIG PL
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/10 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 39/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan, 2 mg/ml, roztwór do infuzji
DE/H/3456/006 R/0717 PFIZER EUROPE MA EEIG PL
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/07 PFIZER EUROPE MA EEIG RO
Diflucan 10 mg/ml pulbere pentru suspensie orală
DE/H/3456/005 4067/2011/03 PFIZER EUROPE MA EEIG RO
Diflucan 10 mg/ml pulbere pentru suspensie orală
DE/H/3456/005 4067/2011/01 PFIZER EUROPE MA EEIG RO
Diflucan 10 mg/ml pulbere pentru suspensie orală
DE/H/3456/005 4067/2011/04 PFIZER EUROPE MA EEIG RO
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/09 PFIZER EUROPE MA EEIG RO
Diflucan 40 mg/ml prašek za peroralno suspenzijo
DE/H/3456/008 H/93/00473/115 PFIZER LUXEMBOURG SARL SI
Diflucan 40 mg/ml pó para suspensão oral
DE/H/3456/008 2132280 LABORATÓRIOS PFIZER, LDA. PT
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/06 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 40/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/04 PFIZER EUROPE MA EEIG RO
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/12 PFIZER EUROPE MA EEIG RO
TRIFLUCAN 50 mg, gélule DE/H/3456/001 34009 330 552 7 1 PFIZER HOLDING FRANCE FR
Diflucan 200 mg hard capsules
DE/H/3456/004 PA 0822/211/003 PFIZER HEALTHCARE IRELAND
IE
Diflucan 10 mg/ml powder for oral suspension
DE/H/3456/005 PA 0822/211/006 PFIZER HEALTHCARE IRELAND
IE
Diflucan 40 mg/ml, poeder voor orale suspensie
DE/H/3456/008 RVG 15758 PFIZER B.V. NL
Diflucan 40 mg/ml pulver til mikstur, suspensjon
DE/H/3456/008 00-7659 PFIZER AS NO
Diflucan 150 mg hard capsules
DE/H/3456/003 PA 0822/211/002 PFIZER HEALTHCARE IRELAND
IE
Diflucan 50 mg, capsule, hard
DE/H/3456/001 RVG 13038 PFIZER B.V. NL
List of nationally authorised medicinal products EMA/698316/2020 Page 41/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 200 mg, capsule, hard
DE/H/3456/004 RVG 14768 PFIZER B.V. NL
Diflucan I.V. 2 mg/ml, oplossing voor infusie
DE/H/3456/006 RVG 14769 PFIZER B.V. NL
Diflucan 2 mg/ml solution for infusion
DE/H/3456/006 PA 0822/211/004 PFIZER HEALTHCARE IRELAND
IE
Diflucan I.V. 2 mg/ml, oplossing voor infusie
DE/H/3456/006 RVG 14769 PFIZER B.V. NL
Diflucan 100 mg, capsule, hard
DE/H/3456/002 RVG 14767 PFIZER B.V. NL
Diflucan 150 mg, capsule, hard
DE/H/3456/003 RVG 13039 PFIZER B.V. NL
Diflucan 10 mg/ml pulver til mikstur, suspensjon
DE/H/3456/005 00-7658 PFIZER AS NO
Diflucan I.V. 2 mg/ml, oplossing voor infusie
DE/H/3456/006 RVG 14769 PFIZER B.V. NL
Diflucan 40 mg/ml powder for oral suspension
DE/H/3456/008 PA 0822/211/007 PFIZER HEALTHCARE IRELAND
IE
List of nationally authorised medicinal products EMA/698316/2020 Page 42/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan I.V. 2 mg/ml, oplossing voor infusie
DE/H/3456/006 PA 0822/211/005 PFIZER HEALTHCARE IRELAND
IE
Diflucan 10 mg/ml, poeder voor orale suspensie
DE/H/3456/005 RVG 15757 PFIZER B.V. NL
Diflucan 2 mg/ml solution for infusion
DE/H/3456/006 PA 0822/211/005 PFIZER HEALTHCARE IRELAND
IE
Diflucan® 2 mg/ml Infusionslösung
DE/H/3456/006 1-18900 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® 2 mg/ml Infusionslösung
DE/H/3456/006 1-18900 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® 2 mg/ml Infusionslösung
DE/H/3456/006 1-18900 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® 2 mg/ml Infusionslösung
DE/H/3456/006 1-18900 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® 100 mg – Kapseln
DE/H/3456/002 1-18836 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® 10 mg/ml Trockensaft
DE/H/3456/005 1-19988 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
List of nationally authorised medicinal products EMA/698316/2020 Page 43/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267626 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267210 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267917 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267931 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489160 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489158 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489119 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267335 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267145 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 44/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267665 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267196 PFIZER ITALIA S.R.L. IT
Diflucan® 40 mg/ml Trockensaft
DE/H/3456/008 1-19991 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267412 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267905 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267588 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267160 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267754 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489145 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 45/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267374 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489196 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267309 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267208 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267323 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489133 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267261 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267172 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267311 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 46/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267347 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489184 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267816 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267881 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267867 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267792 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267855 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267436 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267350 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 47/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267121 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267133 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267828 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267448 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267273 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267259 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267158 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267362 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267842 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 48/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267234 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267778 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489121 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267246 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267879 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267297 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267222 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267184 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489018 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 49/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489095 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 027267970 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 027267107 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267727 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489071 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267386 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267653 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267640 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489107 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 50/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489069 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267766 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 027267968 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489172 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267400 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267564 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 027267095 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267741 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267893 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 51/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267549 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267285 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267830 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267398 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267525 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267689 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 027267943 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267780 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267537 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 52/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 10 mg/ml polvere per sospensione orale
DE/H/3456/005 027267119 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267487 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267691 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267638 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267602 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267590 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267576 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267552 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489020 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 53/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267499 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267475 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489044 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267677 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267501 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489083 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267715 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267614 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489057 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 54/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 200 mg capsule rigide
DE/H/3456/004 027267994 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267513 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267703 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267739 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 043489032 PFIZER ITALIA S.R.L. IT
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267020 PFIZER ITALIA S.R.L. IT
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267018 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 027267032 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267451 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 55/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 200 mg capsule rigide
DE/H/3456/004 027267956 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267463 PFIZER ITALIA S.R.L. IT
Diflucan 200 mg capsule rigide
DE/H/3456/004 027267982 PFIZER ITALIA S.R.L. IT
Diflucan 100 mg capsule rigide
DE/H/3456/002 027267044 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 027267071 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 027267083 PFIZER ITALIA S.R.L. IT
Diflucan 10 mg/ml por belsőleges szuszpenzióhoz
DE/H/3456/005 OGYI-T-1550/07 PFIZER KFT. HU
Diflucan 40 mg/ml por belsőleges szuszpenzióhoz
DE/H/3456/008 OGYI-T-1550/08 PFIZER KFT. HU
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267804 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 56/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule rigide
DE/H/3456/001 027267424 PFIZER ITALIA S.R.L. IT
Diflucan® 150 mg – Kapseln
DE/H/3456/003 1-19976 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® 200 mg – Kapseln
DE/H/3456/004 1-18835 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® 50 mg – Kapseln
DE/H/3456/001 1-18838 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® i.v. 2 mg/ml Infusionslösung
DE/H/3456/006 18943.01.02 PFIZER PHARMA PFE GMBH DE
Diflucan® i.v. 2 mg/ml Infusionslösung
DE/H/3456/006 18943.01.02 PFIZER PHARMA PFE GMBH DE
Diflucan hörð hylki DE/H/3456/004 990116 PFIZER APS IS
Diflucan® Saft 50 mg/10 ml Lösung zum Einnehmen
DE/H/3456/007 18943.00.01 PFIZER PHARMA PFE GMBH DE
Diflucan® 100 mg Hartkapseln
DE/H/3456/002 18943.01.00 PFIZER PHARMA PFE GMBH DE
List of nationally authorised medicinal products EMA/698316/2020 Page 57/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan® Trockensaft 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen
DE/H/3456/005 18943.00.03 PFIZER PHARMA PFE GMBH DE
Diflucan® 40 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen
DE/H/3456/008 89459.00.00 PFIZER PHARMA PFE GMBH DE
Diflucan hörð hylki DE/H/3456/003 870265 PFIZER APS IS
Diflucan® i.v. 2 mg/ml Infusionslösung
DE/H/3456/006 18943.01.02 PFIZER PHARMA PFE GMBH DE
Fungata® DE/H/3456/003 15824.00.00 PFIZER PHARMA PFE GMBH DE
Diflucan® 50 mg Hartkapseln
DE/H/3456/001 18943.00.00 PFIZER PHARMA PFE GMBH DE
Diflucan hörð hylki DE/H/3456/001 870264 PFIZER APS IS
Diflucan® 200 mg Hartkapseln
DE/H/3456/004 18943.02.00 PFIZER PHARMA PFE GMBH DE
List of nationally authorised medicinal products EMA/698316/2020 Page 58/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 10 mg/ml mixtúruduft, lausn.
DE/H/3456/005 920009 PFIZER APS IS
Diflucan 150 mg hårda kapslar
DE/H/3456/003 10898 PFIZER AB SE
Diflucan 200 mg hårda kapslar
DE/H/3456/004 11156 PFIZER AB SE
Diflucan 100 mg hårda kapslar
DE/H/3456/002 11155 PFIZER AB SE
Diflucan 50 mg hårda kapslar
DE/H/3456/001 11154 PFIZER AB SE
Diflucan 40 mg/ml pulver till oral suspension
DE/H/3456/008 11345 PFIZER AB SE
Diflucan 150 mg cietās kapsulas
DE/H/3456/003 02-0251 PFIZER EUROPE MA EEIG LV
Diflucan 10 mg/ml pulver till oral suspension
DE/H/3456/005 11344 PFIZER AB SE
Diflucan 10 mg/ml polvere per sospensione orale
DE/H/3456/005 027267057 PFIZER ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 59/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DIFLUCAN 150 mg tvrdé kapsuly
DE/H/3456/003 26/0111/12–S PFIZER EUROPE MA EEIG SK
DIFLUCAN P.O.S. 10 mg/ml prášok na perorálnu suspenziu
DE/H/3456/005 26/0256/96-S PFIZER EUROPE MA EEIG SK
DIFLUCAN P.O.S. 40 mg/ml prášok na perorálnu suspenziu
DE/H/3456/008 26/0142/12-S PFIZER EUROPE MA EEIG SK
DIFLUCAN 100 mg tvrdé kapsuly
DE/H/3456/002 26/0110/12–S PFIZER EUROPE MA EEIG SK
DIFLUCAN 50 mg tvrdé kapsuly
DE/H/3456/001 26/0121/91–C/S PFIZER EUROPE MA EEIG SK
Diflucan, 2 mg/ml, roztwór do infuzji
DE/H/3456/006 R/0717 PFIZER EUROPE MA EEIG PL
Diflucan 2 mg/ml solution pour perfusion
DE/H/3456/006 BE444026 PFIZER S.A. (BELGIUM) BE
Diflucan 2 mg/ml soluzione per infusione
DE/H/3456/006 043489210 PFIZER ITALIA S.R.L. IT
Diflucan 2 mg/ml soluţie perfuzabilă
DE/H/3456/006 6166/2014/05 PFIZER EUROPE MA EEIG RO
List of nationally authorised medicinal products EMA/698316/2020 Page 60/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Diflucan 50 mg capsule DE/H/3456/001 5124/2012/16 PFIZER EUROPE MA EEIG RO
Diflucan 50 mg cápsulas duras.
DE/H/3456/001 58.765 VINCIFARMA S.A. ES
Diflucan 150 mg capsule rigide
DE/H/3456/003 027267929 PFIZER ITALIA S.R.L. IT
Diflucan, infusionsvæske, opløsning
DE/H/3456/006 13397 PFIZER APS DK
Tesco Health Thrush Relief 150mg Capsule
not available PL 20395/0042 RELON CHEM LIMITED UK
Fluconazole 150mg Capsules
not available PL 20395/0042 RELON CHEM LIMITED UK
Bells Healthcare Thrush Relief Oral 150mg Capsule
not available PL 20395/0042 RELON CHEM LIMITED UK
Fluconazole 150mg Capsules
not available PL 20395/0041 RELON CHEM LIMITED UK
Canesten Thrush Duo Oral Capsule & External Cream 150mg / 2% w/w capsule & cream
not available PL 00010/0652 BAYER PLC UK
List of nationally authorised medicinal products EMA/698316/2020 Page 61/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
FLUCONAZOLE PFIZER 50 mg, gélule
DE/H/3457/001 34009 338 679 6 6 PFIZER HOLDING FRANCE FR
FLUCONAZOLE PFIZER 50 mg, gélule
DE/H/3457/001 34009 558 948 6 5 PFIZER HOLDING FRANCE FR
FLUCONAZOLE PFIZER 50 mg, gélule
DE/H/3457/001 34009 338 680 4 8 PFIZER HOLDING FRANCE FR
FLUCONAZOLE PFIZER 50 mg/5 ml, poudre pour suspension buvable
DE/H/3457/005 34009 338 682 7 7 PFIZER HOLDING FRANCE FR
Fungata® 150 mg – Kapsel
DE/H/3457/006 1-18837 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Diflucan® Derm Saft 50 mg/10 ml Lösung zum Einnehmen
DE/H/3457/002 28858.00.01 PFIZER PHARMA PFE GMBH DE
Fluconazol Pfizer 150 mg Hartkapseln
DE/H/3457/006 90450.00.00 PFIZER PHARMA PFE GMBH DE
Fluconazol Pfizer 200 mg Hartkapseln
DE/H/3457/004 89511.00.00 PFIZER PHARMA PFE GMBH DE
Fluconazol Pfizer 10 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen
DE/H/3457/005 89509.00.00 PFIZER PHARMA PFE GMBH DE
List of nationally authorised medicinal products EMA/698316/2020 Page 62/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fluconazol Pfizer 100 mg Hartkapseln
DE/H/3457/003 89510.00.00 PFIZER PHARMA PFE GMBH DE
Diflucan® Derm 50 mg Hartkapseln
DE/H/3457/001 28858.00.00 PFIZER PHARMA PFE GMBH DE
FLUCONAZOLE PFIZER 10 mg/ml, poudre pour suspension buvable
DE/H/3457/005 34009 338 682 7 7 PFIZER HOLDING FRANCE FR
FLUCONAZOLE PFIZER 100 mg, gélule
DE/H/3457/003 34009 346 591 7 1 PFIZER HOLDING FRANCE FR
FLUCONAZOLE PFIZER 200 mg, gélule
DE/H/3457/004 34009 346 590 0 3 PFIZER HOLDING FRANCE FR
FLUCONAZOLE PFIZER 100 mg, gélule
DE/H/3457/003 34009 338 672 1 8 PFIZER HOLDING FRANCE FR
FLUCONAZOLE PFIZER 200 mg, gélule
DE/H/3457/004 34009 338 677 3 7 PFIZER HOLDING FRANCE FR
Fluconazole 100 mg capsules, hard
PT/H/1954/002 PL 16363/0316 MILPHARM LIMITED UK
Fluconazol Aurobindo 150 mg Hartkapseln
PT/H/1954/003 72224.00.00 AUROBINDO PHARMA GMBH DE
List of nationally authorised medicinal products EMA/698316/2020 Page 63/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/01 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/02 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/03 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/04 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/05 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/06 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/07 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/08 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/09 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
List of nationally authorised medicinal products EMA/698316/2020 Page 64/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/10 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/11 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/12 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/13 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/14 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/15 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/16 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/17 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/18 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
List of nationally authorised medicinal products EMA/698316/2020 Page 65/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fluconazol Aurobindo 100 mg capsule
PT/H/1954/002 10618/2018/19 AUROBINDO PHARMA ROMÂNIA S.R.L.
RO
Fluconazole 50 mg Capsules
not available PL 36722/0120 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Fluconazole 100 mg Capsules
not available PL 36722/0121 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Fluconazole 150 mg Capsules
not available PL 36722/0122 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Fluconazole 200 mg Capsules
not available PL 36722/0123 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Fluconazol Kern Pharma 150 mg cápsulas duras
not available 59.059 KERN PHARMA, S.L. ES
ELAZOR 200 mg capsule rigide
not available 027268097 ALFASIGMA S.P.A. IT
ELAZOR 150 mg capsule rigide
not available 027268022 ALFASIGMA S.P.A. IT
ELAZOR 100 mg capsule rigide
not available 027268046 ALFASIGMA S.P.A. IT
List of nationally authorised medicinal products EMA/698316/2020 Page 66/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ELAZOR 50 mg capsule rigide
not available 027268010 ALFASIGMA S.P.A. IT
Fluconazol B. Braun 2 mg/ml Infusionslösung
DE/H/1055/001 1-28430 B.BRAUN MELSUNGEN AG AT
Fluconazol B. Braun 2 mg/ml Infusionsl テカ sung
DE/H/1055/001 69716.00.00 B.BRAUN MELSUNGEN AG DE
Fluconazole 50 mg Capsules
not available PL 36722/0120 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Fluconazole 100 mg Capsules
not available PL 36722/0121 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Fluconazole 150 mg Capsules
not available PL 36722/0122 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Fluconazole 200 mg Capsules
not available PL 36722/0123 SPECIAL CONCEPT DEVELOPMENT (UK) LTD
UK
Careway Thrush Relief 150mg Hard Capsules
not available 29831/0318 WOCKHARDT UK LTD UK
Lloyds Pharmacy Single Dose Thrush Relief 150mg Hard Capsules
not available 29831/0318 WOCKHARDT UK LTD UK
List of nationally authorised medicinal products EMA/698316/2020 Page 67/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Fluconazole 150mg Hard Capsules
not available 29831/0318 WOCKHARDT UK LTD UK
Fluconazole 200mg Hard Capsules
not available 29831/0305 WOCKHARDT UK LTD UK
Fluconazole 50mg Hard Capsules
not available 29831/0294 WOCKHARDT UK LTD UK
Diflucan 150 mg tvrde kapsule
not available HR-H-744744897 PFIZER CROATIA D.O.O. HR
Diflucan 100 mg tvrde kapsule
not available HR-H-503344712 PFIZER CROATIA D.O.O. HR
Diflucan 50 mg tvrde kapsule
not available HR-H-595109192 PFIZER CROATIA D.O.O. HR
Diflucan 10 mg/ml prašak za oralnu suspenziju
not available HR-H-705762545 PFIZER CROATIA D.O.O. HR
MYCAZOLE not available 27544/14 VERISFIELD (UK) LTD GR
MYCAZOLE not available 27545/14 VERISFIELD (UK) LTD GR
List of nationally authorised medicinal products EMA/698316/2020 Page 68/68
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
MYCAZOLE 200 mg κόνις για πόσιμο διάλυμα
not available 27546/14 VERISFIELD (UK) LTD GR
Fluconazol "Hexal" DK/H/0440/002 32818 HEXAL A/S DK
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