Details

Product Name in the RMS: Sertraline Apotex 50 mg, filmomhulde tabletten

MR Number: NL/H/2800/001
Date of outcome: 28.10.2013

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	sertraline hydrochloride 50 mg
Form	Film coated tablet
MA Holder in the RMS	Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands
RMS	Netherlands
Date of last change	24.08.2018
ATC-Code	N06AB06 Sertraline

CMS Country	Domestic Product Name
Belgium	Sertraline Apotex 50 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten
Czech Republic	Sertralin Apotex 50 mg potahované tablety
Luxembourg
Poland	Sertraline Apotex
Spain

Documents
PAR:	NL_H_2800_001_PAR.pdf (12.05.2014)
FinalPL:	NL_H_2800_001_FinalPL.pdf (16.04.2014)