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 BV Archimedesweg 2 2333 CN Leiden The Netherlands
RMS	Netherlands
Date of last change	30.11.2021
ATC-Code	N06AB06 Sertraline

CMS Country	Domestic Product Name
Czech Republic
Poland

Documents
PAR:	NL_H_2800_001_PAR.pdf (12.05.2014)
FinalSPC:	NL_H_2800_001_FinalSPC.pdf (01.10.2021)
FinalPL:	NL_H_2800_001_FinalPL.pdf (29.09.2021)
Finalised Product Information:	NL_H_2800_001_FinalPI_1of4.pdf (04.03.2021)
Finalised Product Information:	NL_H_2800_001_FinalPI_2of4.pdf (04.03.2021)
Finalised Product Information:	NL_H_2800_001_FinalPI_3of4.pdf (04.03.2021)
Finalised Product Information:	NL_H_2800_001_FinalPI_4of4.pdf (04.03.2021)