Details

Product Name in the RMS: Pivmecillinamhydrochlorid "Karo Pharma"

MR Number: DK/H/2327/001
Date of outcome: 10.09.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	pivmecillinam hydrochloride 400 mg
Form	Film coated tablet
MA Holder in the RMS	Karo Pharma AB Box 16184 103 24 Stockholm Sweden
RMS	Denmark
Date of last change	16.12.2020
ATC-Code	J01CA08 Pivmecillinam

CMS Country	Domestic Product Name
Belgium	Selexid 400mg filmomhulde tabletten
Germany	Selexid 400
Ireland
Italy
Luxembourg	Selexid 400 mg Comprimé pelliculé
Netherlands
Poland
Spain

Documents
PAR:	DK_H_2327_001_PAR.pdf (22.05.2017)
PARSummary:	DK_H_2327_001_PARSummary.pdf (18.09.2015)
FinalSPC:	DK_H_2327_001_FinalSPC.pdf (10.09.2019)
FinalPL:	DK_H_2327_001_FinalPL.pdf (10.09.2019)
FinalLabelling:	DK_H_2327_001_FinalLabelling.pdf (10.09.2019)
Finalised Product Information:	DK_H_2327_001_FinalPI_1of4.pdf (10.09.2014)
Finalised Product Information:	DK_H_2327_001_FinalPI_2of4.pdf (10.09.2014)
Finalised Product Information:	DK_H_2327_001_FinalPI_3of4.pdf (10.09.2014)
Finalised Product Information:	DK_H_2327_001_FinalPI_4of4.pdf (10.09.2014)