13 September 2017 EMA/699912/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: levobunolol (ophthalmic indication)
Procedure no.: PSUSA/00010109/201701
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product name (in authorisation country)
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BE136184
BE
BETAGAN 0,5 %, collyre en solution en récipient unidose BETAGAN 0,5 %, collyre en solution en récipient unidose BETAGAN 0,5 %, collyre en solution en récipient unidose BETAGAN 0,5 %, collyre en solution en récipient unidose BETAGAN 0,5 POUR CENT, collyre en solution BETAGAN 0,5 POUR CENT, collyre en solution BETAGAN 0,5 POUR CENT, collyre en solution Betagan 0,50% collyre en solution
not available
34009 342 393 6 6
ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN FRANCE
not available
34009 342 394 2 7
ALLERGAN FRANCE
FR
not available
34009 342 395 9 5
ALLERGAN FRANCE
FR
not available
34009 345 861 0 1
ALLERGAN FRANCE
FR
not available
34009 328 493 7 6
ALLERGAN FRANCE
FR
not available
34009 328 153 1 9
ALLERGAN FRANCE
FR
not available
34009 328 154 8 7
ALLERGAN FRANCE
FR
not available
BE136184
BE
Betagan 0,50% collyre en solution
not available
1279/07109473
Betagan 0,50% oogdruppels, oplossing
not available
BE136184
Betagan 0.5% w/v Eye Drops, Solution
not available
PA 148/40/1
Betagan 0.5% w/v Unit Dose Eye Drops, Solution
not available
PA 148/40/4
Betagan 5 mg/ml colirio en solución Betagan Eye Drops 0.5% w/v
not available not available
58127 PL 00426/0060
ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN, S.A.U. ALLERGAN LTD
BETAGAN 0,5 % Augentropfen
List of nationally authorised medicinal products EMA/699912/2017
FR
LU BE IE IE ES UK
Page 2/3
Product name (in authorisation country)
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
RVG 11203
NL
Betagan Unit Dose Vistagan 0.5% w/v οφθαλμικές σταγόνες, διάλυμα
not available not available
PL 00426/0072 91684
VISTAGAN 5 mg/ml collirio, soluzione VISTAGAN 5 mg/ml collirio, soluzione VISTAGAN Liquifilm 0,5 % Augentropfen
not available
025737065
ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN LTD ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN S.P.A.
not available
025737014
ALLERGAN S.P.A.
IT
not available
1-20479
AT
VISTAGAN Liquifilm 0,5 % Augentropfen
not available
4762.00.00
VISTAGAN Liquifilm 0,5 % O.K. Augentropfen
not available
22317.00.00
VISTAGAN Liquifilm 0,5 % Oční kapky, roztok
not available
64/042/88-B/C
Vistagan Liquifilm 5 mg/ml oldatos szemcsepp
not available
OGYI-T-1685/02
VISTAGAN Liquifilm unkonserviert 0,5 % Augentropfen
not available
1-20480
ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND ALLERGAN PHARMACEUTICALS IRELAND
Betagan Liquifilm 0,5%, oogdruppels, oplossing
List of nationally authorised medicinal products EMA/699912/2017
UK GR IT
DE DE CZ HU AT
Page 3/3
