Details

Product Name in the RMS: Amisulprid Generics 400 mg

MR Number: SK/H/0150/004
Date of outcome: 28.07.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	amisulpride 400 mg
Form	Film coated tablet
MA Holder in the RMS	Mylan Ireland Limited Unit 35/36 Grange Parade Baldoyle Industrial Estate Dublin 13, Ireland
RMS	Slovak Republic
Date of last change	13.10.2021
ATC-Code	N05AL05 Amisulpride

CMS Country	Domestic Product Name
France
Germany	Amisulprid Mylan 400 mg Filmtabletten
Italy
Spain
XI

Documents
FinalPL:	SK_H_0150_004_FinalPL_1of2.pdf (26.08.2021)
FinalPL:	SK_H_0150_004_FinalPL_2of2.pdf (26.08.2021)
Finalised Product Information:	SK_H_0150_004_FinalPI_1of2.pdf (18.03.2020)
Finalised Product Information:	SK_H_0150_004_FinalPI_2of2.pdf (18.03.2020)