Details

Product Name in the RMS: Nobabelle Cala 0.075 mg / 0.020 mg tablets

MR Number: NL/H/2955/001
Date of outcome: 11.12.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	ethinyl estradiol 20 µg gestodene 75 µg
Form	Tablet
MA Holder in the RMS	EGIS Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Hungary
RMS	Netherlands
Date of last change	05.02.2019
ATC-Code	G03AA10 Gestodene and estrogen

CMS Country	Domestic Product Name
Hungary
Poland
Slovak Republic	NOBABELLE 20 Daily

Documents
PAR:	NL_H_2955_001_PAR.pdf (28.10.2015)
PARSummary:	NL_H_2955_001_PARSummary.pdf (28.10.2015)
FinalSPC:	NL_H_2955_001_FinalSPC_1of2.pdf (24.08.2018)
FinalSPC:	NL_H_2955_001_FinalSPC_2of2.pdf (24.08.2018)
FinalPL:	NL_H_2955_001_FinalPL_1of2.pdf (24.08.2018)
FinalPL:	NL_H_2955_001_FinalPL_2of2.pdf (24.08.2018)
FinalLabelling:	NL_H_2955_001_FinalLabelling_1of2.pdf (24.08.2018)
FinalLabelling:	NL_H_2955_001_FinalLabelling_2of2.pdf (24.08.2018)