05 May 2017 EMA/382258/2015 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): penciclovir
Procedure No.: PSUSA/00002333/201608
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Product full name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Fenistil Cold Sore Cream Fenistil Penciclovir 10 mg/g, crème Fenivir – Fieberblasencreme Fenivir 1 % Fieberblasencreme, abdeckend Fenivir 1 % kremas Fenivir 1 % kremas Fenivir 1% krēms Fenivir 10 mg/g crema
not available not available
PL 02855/0306 RVG 22336
not available SE/H/1410/001
1-21933 135928
OMEGA PHARMA LTD OMEGA PHARMA NEDERLAND B.V. RICHARD BITTNER AG, RICHARD BITTNER AG,
not available not available not available UK/H/0129/001
LT/1/99/0307/001 LT/1/99/0307/002 02-0037 61.462
Fenivir Fenivir Fenivir Fenivir
not available not available not available UK/H/0129/001
OGYI-T-5836/01 OGYI-T-5836/02 OGYI-T-5836/03 81664/15/08-01-2016
Fenivir TM Kρέμα
UK/H/0129/001
81664/15/08-01-2016
Fenivir TM Kρέμα
UK/H/0129/001
81664/15/08-01-2016
Fenivir TM Kρέμα
UK/H/0129/001
81664/15/08-01-2016
Fenivir, 10 mg/g (1%) kreem Fenivir, 10 mg/g, Creme
not available UK/H/0129/001
270199 2671089
Fenivir, 10 mg/g, Creme
UK/H/0129/001
5137716
Fenivir, 10 mg/g, Creme
UK/H/0129/001
2671188
Fenivir, 10 mg/g, Creme
UK/H/0129/001
2671287
Pencivir bei Lippenherpes Gefärbte Creme Penciclovir 10 mg/g Creme Pencivir bei Lippenherpes Penciclovir 10 mg/g Creme Vectatone 1 % emulsiovoide
not available
36056.00.00
not available
36057.00.00
SE/H/1410/001
32206
10 mg/g krém 10 mg/g krém 10 mg/g krém TM Kρέμα
List of nationally authorised medicinal products EMA/382258/2015
Member State where product is authorised UK NL AT AT
RICHARD BITTNER AG, RICHARD BITTNER AG, RICHARD BITTNER AG, OMEGA PHARMA ESPAÑA, S.A. RICHARD BITTNER AG, RICHARD BITTNER AG, RICHARD BITTNER AG, OMEGA PHARMA HELLAS S.A. OMEGA PHARMA HELLAS S.A. OMEGA PHARMA HELLAS S.A. OMEGA PHARMA HELLAS S.A. RICHARD BITTNER AG, OMEGA PHARMA PORTUGUESA LDA OMEGA PHARMA PORTUGUESA LDA OMEGA PHARMA PORTUGUESA LDA OMEGA PHARMA PORTUGUESA LDA OMEGA PHARMA DEUTSCHLAND GMBH
LT LT LV ES
OMEGA PHARMA DEUTSCHLAND GMBH OMEGA PHARMA NORDIC AB
DE
HU HU HU GR GR GR GR EE PT PT PT PT DE
FI
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Product full name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Vectatone 1 % kräm
SE/H/1410/001
48482
Vectatone 1 % krem
SE/H/1410/001
14-10045
Vectatone 1% krem
SE/H/1410/001
IS/1/14/060/01
Vectatone, creme
SE/H/1410/001
54185
Vectavir 1 % emulsiovoide
UK/H/0129/001
12325
Vectavir 1 % emulsiovoide
UK/H/0129/001
12325
Vectavir 1 % kräm
not available
12824
Vectavir 1% Creme
UK/H/0129/001
BE180397
Vectavir 1% Creme
UK/H/0129/001
2008120195
Vectavir 1%, crème
UK/H/0129/001
BE180397
Vectavir 1%, crème
UK/H/0129/001
BE180397
Vectavir 1%, crème
UK/H/0129/001
2008120195
Vectavir 10 mg/g dermálny krém Vectavir 10 mg/ml krem
not available not available
46/0074/98-S 950246
Vectavir Cold Sore Cream
UK/H/0129/001
PA1186/020/001
Vectavir Cold Sore Cream VECTAVIR tónovaný krém na opary 10 mg/g krém Vectavir, creme
UK/H/0129/001 not available
PL 02855/0268 46/314/01 – C
OMEGA PHARMA NORDIC AB OMEGA PHARMA NORDIC AB OMEGA PHARMA NORDIC AB OMEGA PHARMA NORDIC AB OMEGA PHARMA NORDIC AB OMEGA PHARMA NORDIC AB OMEGA PHARMA NORDIC AB OMEGA PHARMA BELGIUM NV OMEGA PHARMA BELGIUM NV OMEGA PHARMA BELGIUM NV OMEGA PHARMA BELGIUM NV OMEGA PHARMA BELGIUM NV OMEGA PHARMA A.S. OMEGA PHARMA NORDIC AB CHEFARO IRELAND LIMITED OMEGA PHARMA LTD OMEGA PHARMA A.S.
not available
17777
Vectavir® 1 % krem
not available
97-5262
List of nationally authorised medicinal products EMA/382258/2015
OMEGA PHARMA NORDIC AB OMEGA PHARMA NORDIC AB
Member State where product is authorised SE NO IS DK FI FI SE BE LU BE BE LU SK IS IE UK CZ DK NO
Page 3/4
Product full name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
ФЕНИВИР 1% Kрем
not available
9900019
ADRIATIC BST D.O.O
List of nationally authorised medicinal products EMA/382258/2015
Member State where product is authorised BG
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