Details
Product Name in the RMS: Wamlox 5 mg/80 mg film-coated tablet
MR Number: HU/H/0403/001
Date of outcome: 17.12.2015
Type of application | |
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Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
amlodipine besilate 5 mg valsartan 80 mg |
Form | Film coated tablet |
MA Holder in the RMS |
Krka, d.d., Novo mesto (SI) in HR: KRKA–FARMA d.o.o. (HR) in DE: HCS bvba (BE) |
RMS | Hungary |
Date of last change | 16.01.2021 |
ATC-Code |
C09DB01 Valsartan and amlodipine |
CMS Country | Domestic Product Name |
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Austria | Wamlox 5 mg/80 mg Filmtabletten |
Bulgaria | Valodip |
Croatia | Wamlox 5 mg/80 mg filmom obložene tablete |
Czech Republic | Wamlox 5 mg/80 mg |
Estonia | WAMLOX |
Germany | Valodip 5 mg/80 mg Filmtabletten |
Latvia | Wamlox 5 mg/80 mg apvalkotās tabletes |
Lithuania | Wamlox 5 mg / 80 mg plėvele dengtos tabletės |
Poland | Wamlox |
Romania | WAMLOX 5 mg/80 mg comprimate filmate |
Slovak Republic | Wamlox 5 mg/80 mg filmom obalené tablety |
Slovenia | Wamlox 5 mg/80 mg filmsko obložene tablete |
Documents | |
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PAR: | HU_H_0403_001_PAR.pdf (05.05.2016) |