Details
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 | 11.04.2020 |
ATC-Code |
C10AA07 Rosuvastatin |
CMS Country | Domestic Product Name |
---|---|
Bulgaria | Rossta |
Greece | ROSSTA |
Poland | |
Romania | Rosi 10 mg comprimate filmate |
Documents | |
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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) |