Details
Product Name in the RMS: Amaloris 5 mg/10 mg Film-coated Tablets
MR Number: SI/H/0142/003
Date of outcome: 09.04.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Line Extension Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
amlodipine besilate 5 mg atorvastatin calcium trihydrate 10 mg |
Form | Film coated tablet |
MA Holder in the RMS |
Krka, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto Slovenia |
RMS | Slovenia |
Date of last change | 18.10.2019 |
ATC-Code |
C10BX03 Atorvastatin and amlodipine |
CMS Country | Domestic Product Name |
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Bulgaria | Atordapin |
Czech Republic | Atordapin 5 mg / 10 mg |
Estonia | AMALORIS |
Latvia | |
Lithuania | Atordapin 5 mg/10 mg plėvele dengtos tabletės |
Poland | Atordapin |
Portugal | |
Romania | Atordapin 5 mg/10 mg comprimate filmate |
Slovak Republic | Atordapin 5 mg/10 mg filmom obalené tablety |
Spain |
Documents | |
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Finalised Product Information: | SI_H_0142_003_FinalPI.pdf (04.07.2019) |