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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
17 May 2018 EMA/298399/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: terbinafine
Procedure no.: PSUSA/00002896/201709
List of nationally authorised medicinal products EMA/298399/2018 Page 2/26
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
Terbinafine Dermapharm 10 mg/g kräm
SE/H/1066/001 44905 DERMAPHARM AG SE
Terbiderm 10 mg/g Creme
SE/H/1066/01/DC 1-30749 DERMAPHARM GMBH AT
Tersilat, 10 mg/g, krem SE/H/1066/001 18989 SUN-FARM SP. Z.O.O. PL
Terbiderm Creme 10 mg/g Creme
SE/H/1066/001 83083.00.00 DERMAPHARM AG DE
Lamisil 10 mg/g krem not available 7963 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
NO
Lamisil Spray 1%, huidspray, oplossing
not available RVG 21006 GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V
NL
Lamisil Lotion 1%, oplossing voor cutaan gebruik
not available RVG 21005 GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V
NL
Lamisil 1% uz ādas izsmidzināmais aerosols, šķīdums
not available 97-0122 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
LV
LAMISILATT 10 mg/g, krem
not available R/1191 GLAXOSMITHKLINE CONSUMER HEALTHCARE SP. Z O.O.
PL
Lamisil® ONCETM 1% cutaneous solution
not available 21831 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
CY
Lamisil® AT 1% Spray not available PL 44673/0109 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
List of nationally authorised medicinal products EMA/298399/2018 Page 3/26
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
Lamisil DermGel 1% gels not available 98-0252 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
LV
Lamisil 1% spray not available 17495 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
CY
LAMISIL Κρέμα 1% not available 204060302 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® κρέμα 1% Τοπικό αντιμυκητιασικό φάρμακο
not available 204060303 NOVARTIS (HELLAS) S.A.C.I. GR
Lamisil voetschimmelcrème 10 mg/g, hydrofiele crème
not available RVG 113799 GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V
NL
Lamisil DermGel 1% geel not available 266699 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
EE
Lamisil huidschimmelcrème 10 mg/g, hydrofiele crème
not available RVG 14843 GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V
NL
Terbinafin Wagner 10 mg/g külsőleges oldatos spray
not available OGYI-T-22697/01 WAGNER-PHARMA KFT HU
ЛАМИЗИЛ 1% спрей за кожа, разтвор
not available 20060350 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
BG
TERBINAFINE SANDOZ 250 mg, comprimé sécable
not available 34009 498 907 7 4 SANDOZ FR
List of nationally authorised medicinal products EMA/298399/2018 Page 4/26
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
TERBINAFINE SANDOZ 250 mg, comprimé sécable
not available 34009 498 908 3 5 SANDOZ FR
TERBINAFINE SANDOZ 250 mg, comprimé sécable
not available 34009 498 906 0 6 SANDOZ FR
Terbinafin Sandoz 250 mg Tabletten
not available 26373.01.01 HEXAL AG DE
LAMISILATT DERMGEL 10 mg/g, zel
not available 4948 GLAXOSMITHKLINE CONSUMER HEALTHCARE SP. Z O.O.
PL
LAMISIL 1 POUR CENT, crème
not available 334 958-8 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISIL 1 POUR CENT, crème
not available 334 959-4 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISIL 1 POUR CENT, crème
not available 334 960-2 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISIL 1 POUR CENT, crème
not available 334 961-9 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISIL 1 POUR CENT, crème
not available 379 097-1 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISILATE 1 POUR CENT, crème
not available 334 962-5 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISILATE 1 POUR CENT, crème
not available 357 029-3 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISIL 1% CREME PRD1762012
not available BE457351 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
List of nationally authorised medicinal products EMA/298399/2018 Page 5/26
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
LAMISIL 1% CREME not available BE457351 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Lamisil 1% crème not available BE457351 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
LAMISIL 1% CREME not available BE 159092 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
LAMISIL 1% CREME PRD396279
not available BE 159092 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
LAMISIL 1% CRÈME not available BE 159092 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Lamisil not available 14096 NOVARTIS HEALTHCARE A/S DK
Lamisil® 1%, cream not available MA 107/00501 NOVARTIS CONSUMER HEALTH (UK) LIMITED
MT
LAMISIL®, 1%, Creme not available 2135184 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
LAMISIL®, 1%, Creme not available 2135184 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
List of nationally authorised medicinal products EMA/298399/2018 Page 6/26
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
LAMICOSIL 10 mg/g crema
not available 63675 GLAXOSMITHKLINE CONSUMER HEALTHCARE, S.A.
ES
Lamisil 10 mg/g, hlaup not available 990128(IS) GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
IS
Terbinafin HCL acis 10 mg/g Crème Terbinafinhydrochlorid
not available 88380.00.00 ACIS ARZNEIMITTEL GMBH DE
LAMISIL DERMGEL 1% GEL
not available 97-3304 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
NO
Lamisil 10 mg/g krem not available 910178 (IS) GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
IS
Lamisil DermGel 10 mg/g gel
not available H/93/00872/008 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Lamisil DermGel 10 mg/g gel
not available H/93/00872/009 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Lamisil DermGel 10 mg/g gel
not available H/93/00872/007 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Lamisil DermGel 10 mg/g gel
not available H/93/00872/010 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
List of nationally authorised medicinal products EMA/298399/2018 Page 7/26
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
Lamisil DermGel 10 mg/g gel
not available H/93/00872/011 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Terbinafine Aurobindo 125 mg tablets
NL/H/2399/001 MA807/04701 AUROBINDO PHARMA (MALTA) LIMITED
MT
Terbinafine Mylan 1% crème
UK/H/1497/001 BE365346 MYLAN BVBA/SPRL BE
Terbinafine Mylan 1% crème
UK/H/1497/001 BE365346 MYLAN BVBA/SPRL BE
Terbinafine Mylan 1% Creme
UK/H/1497/001 BE365346 MYLAN BVBA/SPRL BE
Terbisil 10 mg/g Creme UK/H/1497/001 71737.00.00 MYLAN DURA GMBH DE
Terbinafine 1 % Cream UK/H/1497/001 PL 04569/0889 GENERICS [UK] LIMITED UK
TERBINAFINE MYLAN 1%, crème
UK/H/1497/001 NL35252 MYLAN S.A.S FR
Terbinafine Mylan 10 mg/g, creme
UK/H/1497/001 RVG 101608 MYLAN B.V. NL
Lamisil 1% kräm not available 11523 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
SE
LAMISILATE MONODOSE 1%, solution pour application cutanée
SE/H/0992/004 377 068-4 OU 34009 377 068 4 1 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISIL ONCE 1 %, Lösung zur Anwendung auf der Haut
SE/H/992/004 BE291322 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
List of nationally authorised medicinal products EMA/298399/2018 Page 8/26
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
Lamisilmono 1% soluzione cutanea
SE/H/0992/004 038282012 NOVARTIS FARMA S.P.A. IT
Lamisil Once SE/H/992/004 39088 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
DK
Lamisil Once 10 mg/g húðlausn
SE/H/992/004 IS/1/06/017/01 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
IS
Lamisil Solo 1 % liuos iholle
SE/H/0992/004 21966 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
Lamisil Singeldos 1 %, kutan lösning
SE/H/0992/004 23495 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
SE
Lamisil 1x dermálny roztok
SE/H/0992/004 26/0293/06-S GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
SK
LAMISILATT 1 1 % Roztwór na skórę
SE/H/0992/004 12406 GLAXOSMITHKLINE CONSUMER HEALTHCARE SP. Z O.O.
PL
Lamisil 1 10 mg/g solução cutânea
SE/H/0992/004 5929781 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
LamisilOnce 1 % Lösung zur einmaligen Anwendung auf der Haut
SE/H/0992/004 1-26665 GSK-GEBRO CONSUMER HEALTHCARE GMBH
AT
List of nationally authorised medicinal products EMA/298399/2018 Page 9/26
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
Lamisil Uno, 1% nahalahus
SE/H/992/004 520606 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
EE
Lamisil Uno 1% uz ādas lietojams šķīdums
SE/H/0992/004 06-0178 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
LV
LAMISIL UNO 1 % odos tirpalas
SE/H/992/004 LT/1/06/0586/001 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
LT
Lamisil Once 1% cutaneous solution
SE/H/0992/004 PA 0678/121/003 GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LTD
IE
Lamisil 1% liniment, oppløsning
SE/H/0992/004 06-3985 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
NO
LAMICOSIL UNI 10 MG/G SOLUCIÓN CUTÁNEA
SE/H/0992/004 68.285 GLAXOSMITHKLINE CONSUMER HEALTHCARE, S.A.
ES
Lamisil 1x kožní roztok 1%
SE/H/0992/004 26/332/06-C GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
CZ
Lamisil Once 1 % Lösung zur Anwendung auf der Haut
SE/H/0992/004 65563.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
LAMISIL ONCE 1%, SOLUTION POUR APPLICATION CUTANÉE
SE/H/992/004 2007060046 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
LU
List of nationally authorised medicinal products EMA/298399/2018 Page 10/26
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
Lamisil Once 1%, oplossing voor cutaan gebruik
SE/H/0992/004 BE291322 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Lamisil Once 1%, solution pour application cutanée
SE/H/0992/004 BE291322 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Lamisil Once 1%, oplossing voor cutaan gebruik 10mg/g
SE/H/992/004 RVG 33714 GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V
NL
Lamisil ONCE® δερματικό διάλυμα 1%
SE/H/0992/004 2040607 NOVARTIS (HELLAS) S.A.C.I. GR
Lamisil 1 % odos purškalas (tirpalas)
not available LT/1/94/0101/001 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
LT
Lamisil 1% nahasprei, lahus
not available 238798 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
EE
LAMISIL SPRAY 1%, Spray zur Anwendung auf der Haut, Lösung
not available BE276927 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
LAMISIL SPRAY 1%, huidspray, oplossing
not available BE276927 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
LAMISIL SPRAY 1%, solution pour pulvérisation cutanée
not available BE276927 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
List of nationally authorised medicinal products EMA/298399/2018 Page 11/26
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
Lamisil Sprej 10 mg/g kožní sprej, roztok
not available 26/801/99-C GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
CZ
LAMISIL AT 1% GEL not available PL 44673/0108 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Lamisil 1% krēms not available 93-0550 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
LV
Lamisil 1 % emulsiovoide not available 11046 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
Terbinafine 250 mg Tablets
not available PL 21880/0099 MEDREICH PLC UK
Lamisil 1% crème not available 2009050331 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
LU
Terbinafine 250 mg, tablets
not available PL 30684/0225 DAWA LIMITED UK
Terbinafine 250 mg Tablets
not available PL 44041/0033 NOUMED LIFE SCIENCES UK
Lamisil® 1%, cream not available 18386 GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA
CY
LAMISIL 1 % - CREME not available 1-19581 GSK-GEBRO CONSUMER HEALTHCARE GMBH
AT
Lamisil 1% spray cutaneo, soluzione
SE/H/0992/002 028176067 NOVARTIS FARMA S.P.A. IT
List of nationally authorised medicinal products EMA/298399/2018 Page 12/26
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
Lamisil 1% spray cutaneo, soluzione
SE/H/0992/002 028176117 NOVARTIS FARMA S.P.A. IT
Lamisil 10 mg/g solução para pulverização cutânea
SE/H/0992/002 3532686 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Lamisil 10 mg/g solução para pulverização cutânea
SE/H/0992/002 2690386 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Lamisil 1 % Spray, Lösung
SE/H/0992/002 1-22286 GSK-GEBRO CONSUMER HEALTHCARE GMBH
AT
Lamisil 1 % sumute iholle, liuos
SE/H/0992/002 12945 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
Lamisil 1% kutan spray, lösning.
SE/H/0992/002 13760 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
SE
LAMISIL 1 %, solution pour pulvérisation cutanée
SE/H/0992/002 355 855-3 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISIL 1 %, solution pour pulvérisation cutanée
SE/H/0992/002 345 681-2 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
Lamisil® Spray 1 % Spray zur Anwendung auf der Haut, Lösung
SE/H/992/002 41418.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
List of nationally authorised medicinal products EMA/298399/2018 Page 13/26
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
LAMISIL® 1% δερματικό εκνέφωμα, διάλυμα
SE/H/0992/002 204060501 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® 1% δερματικό εκνέφωμα, διάλυμα
SE/H/0992/002 204060502 NOVARTIS (HELLAS) S.A.C.I. GR
Lamisil 1% kreem not available 215998 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
EE
LAMISIL 1% krém not available 26/417/91-S/C GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
CZ
Lamisil 10 mg/g krema not available H/93/00872/004 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Lamisil 10 mg/g krema not available H/93/00872/001 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Lamisil 10 mg/g krema not available H/93/00872/003 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Lamisil 10 mg/g krema not available H/93/00872/002 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Lamisil Dermgel 1% gel not available HR-H-344287404 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
HR
Lamisil 1% krema not available HR-H-374155033 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
HR
List of nationally authorised medicinal products EMA/298399/2018 Page 14/26
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
Lamisil Once 1 % otopina za kožu
not available UP/I-530-09/12-02/176 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
HR
LAMISIL 1% crema not available 028176129 NOVARTIS FARMA S.P.A. IT
DASKIL DermGel 1%, gel not available 028629083 NOVARTIS FARMA S.P.A. IT
DASKIL DermGel 1%, gel not available 028629095 NOVARTIS FARMA S.P.A. IT
DASKIL DermGel 1%, gel not available 028629107 NOVARTIS FARMA S.P.A. IT
LAMISIL dermálna aerodisperzia
not available 26/0155/03-S GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
SK
LAMISIL CREMĂ 10 mg/g cremă
not available 5446/2005/01 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
Lamisil 1% crema not available 59.434 NOVARTIS FARMACÉUTICA S.A.
ES
Lamisil 1% solución cutánea
not available 62.782 NOVARTIS FARMACÉUTICA S.A.
ES
Lamisil 1% solución para pulverización cutánea
not available 62.783 NOVARTIS FARMACÉUTICA S.A.
ES
DASKIL 1% crema not available 028629044 NOVARTIS FARMA S.P.A. IT
LAMISIL 1% crema not available 028176042 NOVARTIS FARMA S.P.A. IT
LAMISIL CREMĂ 10 mg/g cremă
not available 5446/2005/02 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
RO
DASKIL 1% soluzione cutanea
not available 028629057 NOVARTIS FARMA S.P.A. IT
List of nationally authorised medicinal products EMA/298399/2018 Page 15/26
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
DASKIL 1% spray cutaneo, soluzione
not available 028629069 NOVARTIS FARMA S.P.A. IT
DASKIL 1% spray cutaneo, soluzione
not available 028629119 NOVARTIS FARMA S.P.A. IT
LAMISIL 1% soluzione cutanea
SE/H/0992/001 028176055 NOVARTIS FARMA S.P.A. IT
Lamisil 10 mg/gsolução cutânea
SE/H/0992/001 2690287 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Lamisil 1% kutan lösning SE/H/0992/001 13759 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
SE
Lamisil 1 % liuos iholle SE/H/0992/001 12944 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
LAMISIL 1% SOLUTION POUR APPLICATION CUTANEE
SE/H/992/001/MR 2002096731 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
LU
LAMISIL® 1% Δερματικό διάλυμα
SE/H/0992/001 204060401 NOVARTIS (HELLAS) S.A.C.I. GR
TERBINAFINA PENSA 10 mg/g Crema EFG
not available 68.462 PENSA PHARMA, S.A ES
Terbinafin Apofri 10 mg/g kräm
not available 46305 APOFRI AB SE
Ламизил 1% крем not available 20020380 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
BG
List of nationally authorised medicinal products EMA/298399/2018 Page 16/26
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
LAMISIL DERMGEL 1%, Gel
not available BE283464 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
LAMISIL DERMGEL 1%, GEL
not available BE474035 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
LAMISIL DERMGEL 1%, GEL PRD2934179
not available BE474035 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
LAMISIL DERMGEL 1%, gel
not available BE474035 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Lamisil Dermgel 1%, gel not available BE283464 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Lamisil Dermgel 1%, gel not available BE283464 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
BE
Lamisil 10 mg/g dermalno pršilo, raztopina
not available H/93/00872/005 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
Lamisil 10 mg/g dermalno pršilo, raztopina
not available H/93/00872/006 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
SI
LAMISIL AT 1% GEL not available MA 107/00502 NOVARTIS CONSUMER HEALTH (UK) LIMITED
MT
Lamisil Derma 1 % krém not available OGYI-T-1867/10 GLAXOSMITHKLINE-CONSUMER KFT.
HU
List of nationally authorised medicinal products EMA/298399/2018 Page 17/26
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
Lamisil Derma 1 % krém not available OGYI-T-1867/12 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Lamisil Derma 1 % krém not available OGYI-T-1867/11 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Lamisil Derma 1 % krém not available OGYI-T-1867/01 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Lamisil Derma 1 % krém not available OGYI-T-1867/07 GLAXOSMITHKLINE-CONSUMER KFT.
HU
Lamisil Derma 1 % krém not available OGYI-T-1867/02 GLAXOSMITHKLINE-CONSUMER KFT.
HU
LAMISIL 250 mg comprimate
not available 6707/2014/01 NOVARTIS PHARMA GMBH RO
Lamisil 250 mg comprimés
not available 2003118008 NOVARTIS PHARMA N.V. LU
Lamisil 250 mg Tabletten not available 2003118008 NOVARTIS PHARMA N.V. LU
Lamisil 250 mg tabletten not available BE155705 NOVARTIS PHARMA N.V. BE
LAMISIL 1% crema not available 028176129 NOVARTIS FARMA S.P.A. IT
DASKIL DermGel 1%, gel not available 028629083 NOVARTIS FARMA S.P.A. IT
DASKIL DermGel 1%, gel not available 028629095 NOVARTIS FARMA S.P.A. IT
DASKIL DermGel 1%, gel not available 028629107 NOVARTIS FARMA S.P.A. IT
LAMISIL 1% soluzione cutanea
SE/H/0992/001 028176055 NOVARTIS FARMA S.P.A. IT
Lamisil 1% spray cutaneo, soluzione
SE/H/0992/002 028176067 NOVARTIS FARMA S.P.A. IT
Lamisil 1% spray cutaneo, soluzione
SE/H/0992/002 028176117 NOVARTIS FARMA S.P.A. IT
List of nationally authorised medicinal products EMA/298399/2018 Page 18/26
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
LAMISIL DermGel 1%, gel
SE/H/0992/003 028176079 NOVARTIS FARMA S.P.A. IT
Lamisil DermGel 1%, gel SE/H/0992/003 028176081 NOVARTIS FARMA S.P.A. IT
Lamisil DermGel 1%, gel SE/H/0992/003 028176093 NOVARTIS FARMA S.P.A. IT
Lamisilmono 1% soluzione cutanea
SE/H/0992/004 038282012 NOVARTIS FARMA S.P.A. IT
Lamisil not available 14096 NOVARTIS HEALTHCARE A/S DK
Lamisil® 1%, cream not available MA 107/00501 NOVARTIS CONSUMER HEALTH (UK) LIMITED
MT
LAMISIL DermGel 1%, gel
SE/H/0992/003 028176131 NOVARTIS FARMA S.P.A. IT
LAMISIL DermGel 1%, gel
SE/H/0992/003 028176143 NOVARTIS FARMA S.P.A. IT
LAMISIL DermGel 1%, gel
SE/H/0992/003 028176156 NOVARTIS FARMA S.P.A. IT
LAMISIL AT 1% GEL not available MA 107/00502 NOVARTIS CONSUMER HEALTH (UK) LIMITED
MT
Lamisil ONCE® δερματικό διάλυμα 1%
SE/H/0992/004 2040607 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL Κρέμα 1% not available 204060302 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® DermGel® 1% γέλη
SE/H/0992/003 204060602 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® DermGel® 1% γέλη
SE/H/0992/003 204060601 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® DermGel® 1% γέλη
SE/H/0992/003 204060603 NOVARTIS (HELLAS) S.A.C.I. GR
List of nationally authorised medicinal products EMA/298399/2018 Page 19/26
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
LAMISIL® 1% Δερματικό διάλυμα
SE/H/0992/001 204060401 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® 1% δερματικό εκνέφωμα, διάλυμα
SE/H/0992/002 204060501 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® 1% δερματικό εκνέφωμα, διάλυμα
SE/H/0992/002 204060502 NOVARTIS (HELLAS) S.A.C.I. GR
Lamisil 250 mg tablete not available H/93/02072/004 NOVARTIS PHARMA GMBH SI
Lamisil 125 mg tablete not available H/93/02072/001 NOVARTIS PHARMA GMBH SI
Lamisil 250 mg tablete not available H/93/02072/003 NOVARTIS PHARMA GMBH SI
Lamisil 125 mg tablete not available H/93/02072/002 NOVARTIS PHARMA GMBH SI
DASKIL 125 mg Compresse
not available 028629020 NOVARTIS FARMA S.P.A. IT
LAMISIL 250 mg Compresse
not available 028176028 NOVARTIS FARMA S.P.A. IT
LAMISIL 250 mg Compresse
not available 028176105 NOVARTIS FARMA S.P.A. IT
Lamisil 250 mg Comprimidos
not available 2134989 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
Lamisil 250 mg Comprimidos
not available 2135085 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
Lamisil 250 mg tabletės not available LT/1/94/0101/004 NOVARTIS FINLAND OY LT
Lamisil 1% crema not available 59.434 NOVARTIS FARMACÉUTICA S.A.
ES
Lamisil 125 mg tabletter not available 11044 NOVARTIS FINLAND OY FI
List of nationally authorised medicinal products EMA/298399/2018 Page 20/26
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
Lamisil 125 mg tabletti not available 11044 NOVARTIS FINLAND OY FI
Lamisil 250 mg comprimidos
not available 59435 NOVARTIS FARMACÉUTICA S.A.
ES
Lamisil 250 mg tabletes not available 00-0166 NOVARTIS FINLAND OY LV
Lamisil 250 mg tabletter not available 11045 NOVARTIS FINLAND OY FI
Lamisil 250 mg tabletti not available 11045 NOVARTIS FINLAND OY FI
Lamisil, 250 mg tabletid not available 216198 NOVARTIS FINLAND OY EE
Lamisil 125 mg tabletki not available R/1731 NOVARTIS POLAND SP. Z O. O.
PL
Lamisil 250 mg tabletki not available R/1732 NOVARTIS POLAND SP. Z O. O.
PL
ЛАМИЗИЛ 250 mg таблетки
not available 20020372 NOVARTIS PHARMA GMBH BG
Lamisil 250 mg tabletta not available OGYI-T-1866/01 NOVARTIS HUNGÁRIA KFT. PHARMA
HU
Lamisil 250 mg tabletta not available OGYI-T-1866/02 NOVARTIS HUNGÁRIA KFT. PHARMA
HU
Lamisil® 250 mg Tabletten
not available 28025.01.00 NOVARTIS PHARMA GMBH DE
Lamisil pediatric 125 mg tabletta
not available OGYI-T-1866/03 NOVARTIS HUNGÁRIA KFT. PHARMA
HU
LAMISIL® tablets: 250 mg
not available MA088/01401 NOVARTIS PHARMACEUTICALS UK LIMITED
MT
LAMISIL 125 mg tablety not available 26/418/91-A/C NOVARTIS, S.R.O. CZ
List of nationally authorised medicinal products EMA/298399/2018 Page 21/26
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
LAMISIL 250 mg tablety not available 26/418/91-B/C NOVARTIS, S.R.O. CZ
Lamisil 250 mg tabletter not available 11640 NOVARTIS SVERIGE AB SE
LAMISIL 250 mg, comprimé sécable
not available 3400933495596 NOVARTIS PHARMA S.A.S. FR
LAMISIL 250 mg, comprimé sécable
not available 3400933495657 NOVARTIS PHARMA S.A.S. FR
LAMISIL 250 mg, comprimé sécable
not available 3400933495718 NOVARTIS PHARMA S.A.S. FR
LAMISIL? (terbinafine * hydrochloride)
not available 18387 NOVARTIS PHARMACEUTICALS UK LIMITED
CY
LAMISILâ (terbinafine * hydrochloride)
not available 18385 NOVARTIS PHARMACEUTICALS UK LIMITED
CY
Lamisil® Tablets 250mg not available PL 00101/0304 NOVARTIS PHARMACEUTICALS UK LIMITED
UK
Lamisil Tablets 250 mg not available PA0013/045/003 NOVARTIS PHARMACEUTICALS UK LIMITED
IE
DASKIL 1% crema not available 028629044 NOVARTIS FARMA S.P.A. IT
LAMISIL 1% crema not available 028176042 NOVARTIS FARMA S.P.A. IT
Lamisil 250 mg tabletter not available 8088 NOVARTIS NORGE AS NO
DASKIL 250 mg Compresse
not available 028629018 NOVARTIS FARMA S.P.A. IT
List of nationally authorised medicinal products EMA/298399/2018 Page 22/26
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
DASKIL 250 mg Compresse
not available 028629071 NOVARTIS FARMA S.P.A. IT
Lamisil 125 mg Comprimidos
not available 2134781 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
Lamisil 125 mg Comprimidos
not available 2134880 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
Lamisil 250 mg comprimés
not available BE155705 NOVARTIS PHARMA N.V. BE
Lamisil 250 mg tabletten not available BE155705 NOVARTIS PHARMA N.V. BE
DASKIL 1% soluzione cutanea
not available 028629057 NOVARTIS FARMA S.P.A. IT
DASKIL 1% spray cutaneo, soluzione
not available 028629069 NOVARTIS FARMA S.P.A. IT
DASKIL 1% spray cutaneo, soluzione
not available 028629119 NOVARTIS FARMA S.P.A. IT
Lamisil 250 mg tablete not available UP/I-530-09/12-02/273 NOVARTIS HRVATSKA D.O.O. HR
LAMISIL 1% w/w Cream not available PA 678/121/1 GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LTD
IE
Lamisil AT Cream not available PA 678/121/2 GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LTD
IE
Terbiderm Gel, 10 mg/g für Erwachsene
not available 66031.00.00 DERMAPHARM AG DE
List of nationally authorised medicinal products EMA/298399/2018 Page 23/26
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
Terbiderm Spray, 10 mg/g für Erwachsene
not available 66032.00.00 DERMAPHARM AG DE
Terbinafin HCL acis 10 mg/g Gel Terbinafinhydrochlorid Nur für Erwachsene
not available 87153.00.00 ACIS ARZNEIMITTEL GMBH DE
Tersilat, 10 mg/g, aerozol na skórę, roztwór
not available 22036 SUN-FARM SP. Z.O.O. (KOLBIEL)
PL
Atere 10 mg/g krema not available UP/I-530-09/11-01/94 MIBE PHARMACEUTICALS D.O.O.
HR
Terbinafin HCL acis 10 mg/g Spray Terbinafinhydrochlorid Nur für Erwachsene
not available 87154.00.00 ACIS ARZNEIMITTEL GMBH DE
Terbinafine 250 mg tablets
not available PL 20416/0364 CRESCENT PHARMA LIMITED UK
Lamisil not available 96-3559 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
NO
Lamisil Creme 1% Terbinafinhydrochlorid
not available 26373.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
LAMISIL 1% w/w Cream not available PL 44673/0107 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Lamisil AT 1% Cream not available PL 44673/0106 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
List of nationally authorised medicinal products EMA/298399/2018 Page 24/26
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
Boots Athlete's Foot 1% w/w Cream
not available PL 44673/0106 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
Lamisil® OnceTM 1% cutaneous solution
not available PL 44673/0105 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
UK
ЛАМИЗИЛ ДЕРМГЕЛ 1% Гел
not available 20060369 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
BG
Lamisil not available 26/0417/91-S GLAXOSMITHKLINE CONSUMER HEALTHCARE CZECH REPUBLIC S.R.O.
SK
Lamisil DermGel 1 % gelis
not available LT/1/01/3040/001 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
LT
Terbinafine 250 mg tablets
not available PL 40378/0133 TORRENT PHARMA GMBH UK
LAMISIL 1 % kremas not available LT/1/94/0101/002 GLAXOSMITHKLINE CONSUMER HEALTHCARE (UK) TRADING LIMITED
LT
LAMISIL DermGel 1%, gel
SE/H/0992/003 028176079 NOVARTIS FARMA S.P.A. IT
Lamisil DermGel 1%, gel SE/H/0992/003 028176081 NOVARTIS FARMA S.P.A. IT
Lamisil DermGel 1%, gel SE/H/0992/003 028176093 NOVARTIS FARMA S.P.A. IT
Lamisil SE/H/992/003 31237 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
DK
List of nationally authorised medicinal products EMA/298399/2018 Page 25/26
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
Lamisil DermGel 1 % geeli
SE/H/992/003 13752 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
FI
Lamisil Dermgel 1%, gel SE/H/0992/003 14867 GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S
SE
Lamisil DermGel, 10 mg/g, gel
SE/H/0992/003 2866788 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Lamisil DermGel, 10 mg/g, gel
SE/H/0992/003 2866689 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Lamisil DermGel, 10 mg/g, gel
SE/H/0992/003 2866580 GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
PT
Lamisil 1 % DermGel, Gel SE/H/0992/003 1-22946 GSK-GEBRO CONSUMER HEALTHCARE GMBH
AT
LAMISILDERMGEL 1%, GEL
SE/H/0992/003 350 016-3 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISILDERMGEL 1 %, gel
SE/H/0992/003 350 018-6 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISILDERMGEL 1%, GEL
SE/H/0992/003 350 019-2 GLAXOSMITHKLINE SANTE GRAND PUBLIC
FR
LAMISIL DermGel 1%, gel
SE/H/0992/003 028176131 NOVARTIS FARMA S.P.A. IT
List of nationally authorised medicinal products EMA/298399/2018 Page 26/26
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
LAMISIL DermGel 1%, gel
SE/H/0992/003 028176143 NOVARTIS FARMA S.P.A. IT
LAMISIL DermGel 1%, gel
SE/H/0992/003 028176156 NOVARTIS FARMA S.P.A. IT
Lamisil DermGel1% Gel SE/H/992/003 44315.00.00 GLAXOSMITHKLINE CONSUMER HEALTHCARE GMBH & CO. KG
DE
LAMISIL DERMGEL 1%, GEL
SE/H/992/003 2007089437 GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.
LU
LAMISIL DERMGEL 1%, GEL
SE/H/992/003 RVG 24945 GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V
NL
LAMISIL® DermGel® 1% γέλη
SE/H/0992/003 204060602 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® DermGel® 1% γέλη
SE/H/0992/003 204060601 NOVARTIS (HELLAS) S.A.C.I. GR
LAMISIL® DermGel® 1% γέλη
SE/H/0992/003 204060603 NOVARTIS (HELLAS) S.A.C.I. GR
