Code | 8954B | ||||||||||
MA number | EU/1/15/1053/001 | ||||||||||
Product Form: | tbl 10x1x40 mg (blis.OPA/Al/PVC-Al-perf.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | THERAVIA, France | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 16.03.2016 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 15.01.2021 |