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. Pieńków 149 05-152 Czosnów
RMS	Poland
Date of last change	02.11.2018
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
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)