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) |