Code | 47652 | ||||||||||
MA number | 56/0048/08-S | ||||||||||
Product Form: | tbl 30x1mg/0,5 mg | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Adamed Czech Republic s.r.o., Czechia | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 04.03.2008 |
SPC: | SPC_Gynovel_04_2022.pdf |
PIL: | PIL_Gynovel_04_2022.pdf |
Safety feature | Yes |
Data update: | 18.03.2019 |