Medicinal Products

Sildenafil Pliva 20 mg filmom obložene tablete

Name Sildenafil Pliva 20 mg filmom obložene tablete
Marketing Authorisation Number HR-H-575973033
Active Substance sildenafilcitrat
Composition jedna filmom obložena tableta sadrži 20 mg sildenafila (u obliku sildenafilcitrata)
Pharmaceutical Form filmom obložena tableta
Manufacturer Teva Operations Poland Sp. z o.o., Krakow, Poljska
Merckle GmbH, Blaubeuren, Njemačka
Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date 27.01.2021
MA Period of Validity unlimited
Classification Number UP/I-530-09/20-02/124
Registration Number 381-12-01/30-21-03
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

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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