Details

Product Name in the RMS: Zenon 10 mg/20 mg

MR Number: CZ/H/0455/002
Date of outcome: 29.07.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Fixed Combination Chemical Substance Prescription Only
Active Substances	ezetimibe 10 mg rosuvastatin calcium 20,8 mg
Form	Film coated tablet
MA Holder in the RMS	sanofi-aventis, s.r.o. Evropská 846/176a 160 00 Praha 6 - Vokovice Czech Republic
RMS	Czech Republic
Date of last change	20.08.2020
ATC-Code	C10BA06 rosuvastatin and ezetimibe

CMS Country	Domestic Product Name
Bulgaria	Ezetimbe-Rosuvastatin Zentiva
Poland
Slovak Republic	Zenon 10 mg/20 mg

Documents
PARSummary:	CZ_H_0455_002_PARSummary.pdf (12.05.2015)
Finalised Product Information:	CZ_H_0455_002_FinalPI.pdf (13.09.2019)