Details

Product Name in the RMS: Desogestrel/ ethinylestradiol Actavis 150/30 mcg, filmomhulde tabletten

MR Number: NL/H/2752/002
Date of outcome: 15.09.2013

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	desogestrel 150 µg ethinyl estradiol 30 µg
Form	Film coated tablet
MA Holder in the RMS	Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands
RMS	Netherlands
Date of last change	12.05.2020
ATC-Code	G03AA09 Desogestrel and estrogen

CMS Country	Domestic Product Name
Belgium	Benifema 0,15 mg / 0,03 mg filmomhulde tabletten
Germany	Benidette 150 mcg / 20 mcg Filmtabletten

Documents
PAR:	NL_H_2752_002_PAR.pdf (10.04.2014)
FinalSPC:	NL_H_2752_002_FinalSPC.pdf (01.03.2019)
FinalPL:	NL_H_2752_002_FinalPL.pdf (01.03.2019)
FinalLabelling:	NL_H_2752_002_FinalLabelling_1of2.pdf (15.09.2017)
FinalLabelling:	NL_H_2752_002_FinalLabelling_2of2.pdf (15.09.2017)
Finalised Product Information:	NL_H_2752_002_FinalPI_1of2.pdf (27.05.2014)
Finalised Product Information:	NL_H_2752_002_FinalPI_2of2.pdf (27.05.2014)