Details

Product Name in the RMS: Tadalafil PMCS 5 mg Filmtabletten

MR Number: DE/H/3777/001
Date of outcome: 12.06.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	tadalafil 5 mg
Form	Film coated tablet
MA Holder in the RMS	Pro.Med.CS Praha a.s. Telcská 377/1, Michle 140 00 Prague 4 Czech Republic
RMS	Germany
Date of last change	16.02.2020
ATC-Code	G04BE08 Tadalafil

CMS Country	Domestic Product Name
Czech Republic	Tadalafil PMCS 5 mg
Estonia	TADALAFIL PMCS 5 MG
Latvia	Tadalafil PMCS 5 mg apvalkotās tabletes
Lithuania	Tadalafil PMCS 5 mg plėvele dengtos tabletės
Poland	Tadalefil PMCS
Slovak Republic	Tadalafil PMCS 5 mg
Sweden

Documents
PAR:	DE_H_3777_001_PAR.pdf (24.09.2018)
FinalSPC:	DE_H_3777_001_FinalSPC.pdf (13.06.2014)
FinalPL:	DE_H_3777_001_FinalPL_1of2.pdf (13.06.2014)
FinalPL:	DE_H_3777_001_FinalPL_2of2.pdf (13.06.2014)
FinalLabelling:	DE_H_3777_001_FinalLabelling_1of2.pdf (13.06.2014)
FinalLabelling:	DE_H_3777_001_FinalLabelling_2of2.pdf (13.06.2014)
Finalised Product Information:	DE_H_3777_001_FinalPI_1of3.pdf (17.01.2020)
Finalised Product Information:	DE_H_3777_001_FinalPI_2of3.pdf (17.01.2020)
Finalised Product Information:	DE_H_3777_001_FinalPI_3of3.pdf (17.01.2020)