Code | 5893E | ||||||||||
MA number | 56/0063/24-S | ||||||||||
Product Form: | sup 30x4 mg (strip PVC/PVDC/LDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Rectal use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 03.04.2024 |
Validity: | 03.04.2029 |
SPC: | SPC_Budenofalk 4mg_03 2024.pdf |
PIL: | PIL_Budenofalk 4mg_03 2024.pdf |
Safety feature | Yes |
Data update: | 16.04.2024 |