Code | 3117D | ||||||||||
MA number | 83/0392/19-S | ||||||||||
Product Form: | tbl flm 8x5 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Farmak International Sp. z o.o., Poland | ||||||||||
Therapeutic Class: | 83 - VASODILATANTIA | ||||||||||
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: | 13.01.2020 |
SPC: | SPC_Tadalafil FMK 5 mg_tbl flm_07_2024.pdf |
PIL: | PIL_Tadalafil FMK 5 mg_tbl flm_07_2024.pdf |
Safety feature | Yes |
Data update: | 21.06.2024 |