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PRODUCT DETAIL

TADALAFIL FMK 5 mg

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:
G GENITO URINARY SYSTEM AND SEX HORMONES
G04 UROLOGICALS
G04B UROLOGICALS (OTHER UROLOGICALS, INCL. ANTISPASMODICS-delete WHO)
G04BE Drugs used in erectile dysfunction
G04BE08 Tadalafil
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
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