Details

Product Name in the RMS: Nobabelle 0.075 mg / 0.030 mg tablets

MR Number: NL/H/2954/002
Date of outcome: 11.12.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	ethinyl estradiol 30 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	23.09.2018
ATC-Code	G03AA10 Gestodene and estrogen

CMS Country	Domestic Product Name
Czech Republic	Gentilion 0,075 mg/0,030 mg
Hungary
Poland
Slovak Republic	NOBABELLE 30

Documents
PAR:	NL_H_2954_002_PAR.pdf (28.10.2015)
PARSummary:	NL_H_2954_002_PARSummary.pdf (28.10.2015)
FinalSPC:	NL_H_2954_002_FinalSPC_1of2.pdf (24.08.2018)
FinalSPC:	NL_H_2954_002_FinalSPC_2of2.pdf (24.08.2018)
FinalPL:	NL_H_2954_002_FinalPL_1of2.pdf (24.08.2018)
FinalPL:	NL_H_2954_002_FinalPL_2of2.pdf (24.08.2018)
FinalLabelling:	NL_H_2954_002_FinalLabelling_1of2.pdf (24.08.2018)
FinalLabelling:	NL_H_2954_002_FinalLabelling_2of2.pdf (24.08.2018)