Details
Product Name in the RMS: Ditinell 0.060/0.015 mg
MR Number: NL/H/3009/001
Date of outcome: 16.07.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
ethinyl estradiol 15 µg gestodene 60 µg |
Form | Tablet |
MA Holder in the RMS |
Egis Pharmaceuticals PLC Keresztúri út 30-38G.G. H-1106 Budapest Hungary |
RMS | Netherlands |
Date of last change | 06.06.2020 |
ATC-Code |
G03AA10 Gestodene and estrogen |
CMS Country | Domestic Product Name |
---|---|
Czech Republic | Ditinell 0,060 mg/0,015 mg |
Hungary | DITINELL 0,060 mg/0,015 mg filmtabletta |
Documents | |
---|---|
PAR: | NL_H_3009_001_PAR.pdf (12.01.2015) |
PARSummary: | NL_H_3009_001_PARSummary.pdf (12.01.2015) |
FinalSPC: | NL_H_3009_001_FinalSPC.pdf (07.02.2019) |
FinalPL: | NL_H_3009_001_FinalPL.pdf (07.02.2019) |
FinalLabelling: | NL_H_3009_001_FinalLabelling.pdf (07.11.2018) |
Finalised Product Information: | NL_H_3009_001_FinalPI_2of2.pdf (17.07.2014) |