Details
Product Name in the RMS: Candezek Combi
MR Number: PL/H/0379/001
Date of outcome: 20.04.2016
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Full Dossier Chemical Substance Prescription Only |
Active Substances |
amlodipine 5 mg candesartancilexetil 8 mg |
Form | Capsule, hard |
MA Holder in the RMS |
Adamed Sp. z o.o. PieÅ„ków 149 05-152 Czosnów |
RMS | Poland |
Date of last change | 13.06.2020 |
ATC-Code |
C09DB Angiotensin II antagonists and calcium channel blockers |
CMS Country | Domestic Product Name |
---|---|
Bulgaria | Candezek Combi |
Czech Republic | Candezek Combi 8 mg/ 5 mg tvrdá tobolka |
Greece | DESARPIN (ex CANDEZEK COMBI) |
Hungary | |
Slovak Republic | Candezek 8 mg/5 mg |
Documents | |
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FinalSPC: | PL_H_0379_001_FinalSPC.pdf (13.03.2018) |
FinalPL: | PL_H_0379_001_FinalPL.pdf (22.03.2018) |
FinalLabelling: | PL_H_0379_001_FinalLabelling.pdf (11.05.2016) |
Finalised Product Information: | PL_H_0379_001_FinalPI.zip (11.05.2016) |