Details
Product Name in the RMS: Opimol
MR Number: HU/H/0341/001
Date of outcome: 02.06.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Fixed Combination Chemical Substance Prescription Only |
Active Substances |
amlodipine besilate 5 mg bisoprolol fumarate 5 mg |
Form | Tablet |
MA Holder in the RMS |
EGIS Pharmaceuticals PLC H-1106 Budapest, Keresztúri út 30-38. Hungary |
RMS | Hungary |
Date of last change | 23.11.2020 |
ATC-Code |
C07FB07 bisoprolol and other antihypertensives |
CMS Country | Domestic Product Name |
---|---|
Bulgaria | Alotendin |
Czech Republic | Cardiprol 5/5 mg |
Latvia | Alotendin 5 mg/5 mg tabletes |
Lithuania | Alotendin 5 mg/5 mg tabletÄ—s |
Poland | Alotendin |
Romania | Alotendin 5 mg/5 mg comprimate |
Slovak Republic | Bigital 5 mg/5 mg |
Documents | |
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PAR: | HU_H_0341_001_PAR.pdf (29.01.2015) |
FinalSPC: | HU_H_0341_001_FinalSPC.pdf (04.06.2014) |