Details

Product Name in the RMS: Cetirizin Dr. Max 10 mg

MR Number: CZ/H/0769/001
Date of outcome: 02.10.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	cetirizine dihydrochloride 10 mg
Form	Film coated tablet
MA Holder in the RMS	Dr. Max Pharma s.r.o. Na Florenci 2116/15 110 00 Praha 1 - Nové Město Czech Republic FORMER RMS: PT/1186
RMS	Czech Republic
Date of last change	07.12.2018
ATC-Code	R06AE07 Cetirizine

CMS Country	Domestic Product Name
Poland
Slovak Republic	Cetirizine Dr. Max 10 mg filmom obalené tablety

Documents
PAR:	CZ_H_0769_001_PAR.pdf (14.08.2015)
FinalSPC:	CZ_H_0769_001_FinalSPC.pdf (07.11.2018)
FinalPL:	CZ_H_0769_001_FinalPL.pdf (07.11.2018)
FinalLabelling:	CZ_H_0769_001_FinalLabelling.pdf (07.11.2018)
Finalised Product Information:	CZ_H_0769_001_FinalPI_1of3.pdf (02.10.2014)
Finalised Product Information:	CZ_H_0769_001_FinalPI_2of3.pdf (02.10.2014)
Finalised Product Information:	CZ_H_0769_001_FinalPI_3of3.pdf (02.10.2014)