Latest hum. ProductsDetails
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 | 26.01.2019 |
| 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 |
| Slovak Republic | Ditinell 0,06 mg/0,015 mg |
| 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 (07.11.2018) |
| FinalPL: | NL_H_3009_001_FinalPL.pdf (07.11.2018) |
| FinalLabelling: | NL_H_3009_001_FinalLabelling.pdf (07.11.2018) |
| Finalised Product Information: | NL_H_3009_001_FinalPI_2of2.pdf (17.07.2014) |
