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PRODUCT DETAIL

Spedra 50 mg tablety

Code 6353A
MA number EU/1/13/841/002
Product Form: tbl 8x50 mg (PVC/PCTFE/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
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
G04BE10 Avanafil
Shelf life: 60
Container: blister PCTFE/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 13.06.2013
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 21.06.2018
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