Details

Product Name in the RMS: Tadalafil PMCS 10 mg Filmtabletten

MR Number: DE/H/3777/002
Date of outcome: 12.06.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	tadalafil 10 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 10 mg
Estonia	TADALAFIL PMCS 10 MG
Latvia	Tadalafil PMCS 10 mg apvalkotās tabletes
Lithuania	Tadalafil PMCS 10 mg plėvele dengtos tabletės
Poland	Tadalafil PMCS
Slovak Republic	Tadalafil PMCS 10 mg
Sweden

Documents
PAR:	DE_H_3777_002_PAR.pdf (24.09.2018)
FinalSPC:	DE_H_3777_002_FinalSPC.pdf (13.06.2014)
FinalPL:	DE_H_3777_002_FinalPL_1of2.pdf (13.06.2014)
FinalPL:	DE_H_3777_002_FinalPL_2of2.pdf (13.06.2014)
FinalLabelling:	DE_H_3777_002_FinalLabelling_1of2.pdf (13.06.2014)
FinalLabelling:	DE_H_3777_002_FinalLabelling_2of2.pdf (13.06.2014)
Finalised Product Information:	DE_H_3777_002_FinalPI_1of3.pdf (17.01.2020)
Finalised Product Information:	DE_H_3777_002_FinalPI_2of3.pdf (17.01.2020)
Finalised Product Information:	DE_H_3777_002_FinalPI_3of3.pdf (17.01.2020)