Latest hum. ProductsDetails
Product Name in the RMS: Rosi 40 mg, film-coated tablets
MR Number: CZ/H/0483/004
Date of outcome: 11.12.2014
| Type of application | |
|---|---|
|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Generic Chemical Substance Prescription Only |
| Active Substances |
rosuvastatin calcium 41,6 mg |
| Form | Film coated tablet |
| MA Holder in the RMS |
Swyssi AG Lyoner Straße 14 60528 Frankfurt am Main Germany |
| RMS | Czech Republic |
| Date of last change | 08.11.2021 |
| ATC-Code |
C10AA07 Rosuvastatin |
| CMS Country | Domestic Product Name |
|---|---|
| Bulgaria | Rossta |
| Greece | ROSSTA |
| Romania | Rosi 10 mg comprimate filmate |
| Documents | |
|---|---|
| FinalSPC: | CZ_H_0483_004_FinalSPC.pdf (12.03.2020) |
| FinalPL: | CZ_H_0483_004_FinalPL.pdf (12.03.2020) |
| FinalLabelling: | CZ_H_0483_004_FinalLabelling_1of3.pdf (12.03.2020) |
| FinalLabelling: | CZ_H_0483_004_FinalLabelling_2of3.pdf (12.03.2020) |
| FinalLabelling: | CZ_H_0483_004_FinalLabelling_3of3.pdf (12.03.2020) |
