Code | 4199B | ||||||||||
MA number | EU/1/12/750/004 | ||||||||||
Product Form: | tbl 28x5 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Gedeon Richter Plc., Hungary | ||||||||||
Therapeutic Class: | 54 - GYNAECOLOGICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PE/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 23.02.2012 |
Validity: | 30.08.2024 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 25.07.2024 |