Medicinal Products

Sildenafil Alpha-Medical 20 mg filmom obložene tablete

Name Sildenafil Alpha-Medical 20 mg filmom obložene tablete
Marketing Authorisation Number HR-H-193404304
Active Substance sildenafilcitrat
Composition jedna filmom obložena tableta sadrži 20 mg sildenafila (u obliku sildenafilcitrata)
Pharmaceutical Form filmom obložena tableta
Manufacturer Synoptis Industrial Sp. z o.o., Swarzedz, Poljska
Macleods Pharma UK Limited, Wynyard, Billingham, Ujedinjeno Kraljevstvo
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska
Marketing Authorisation Date 12.12.2022
MA Period of Validity unlimited
Classification Number UP/I-530-09/22-02/150
Registration Number 381-12-01/154-22-03
Prescription Medicinal product subject to medical prescription
Type of prescription ograničeni recept
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code G04BE03
Marketing status stavljeno u promet
Shortage status nema nestašice
SmPC download
PL download
Public Assessment Report download
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Packaging

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o prijevremeno prekinutom kliničkom ispitivanju primjene sildenafila za liječenje intrauterinog zastoja rasta 16.10.2018 Alpha-Medical d.o.o., Belupo lijekovi i kozmetika d.d., Krka – farma d.o.o., Pfizer Croatia d.o.o., PharmaS d.o.o., Pliva Hrvatska d.o.o. i Sandoz d.o.o.
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