Code | 3660E | ||||||||||
MA number | 56/0135/23-S | ||||||||||
Product Form: | tbl 50x0,1 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | MAKPHARM d.o.o., Croatia | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 31.05.2023 |
Validity: | 31.05.2028 |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Zonta_05 2023.pdf |
PIL: | PIL_Zonta_05 2023.pdf |
Safety feature | Yes |
Data update: | 15.06.2023 |