Latest hum. ProductsDetails
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 | 05.08.2019 |
| 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 tabletės |
| Poland | Alotendin |
| Romania | Alotendin 5 mg/5 mg comprimate |
| Slovak Republic | Bigital 5 mg/5 mg |
| Documents | |
|---|---|
| PAR: | HU_H_0341_001_PAR.pdf (29.01.2015) |
| FinalSPC: | HU_H_0341_001_FinalSPC.pdf (04.06.2014) |
