Medicinal Products

Neotigason 10 mg tvrde kapsule

Name Neotigason 10 mg tvrde kapsule
Marketing Authorisation Number HR-H-047281874
Active Substance acitretinum
Pharmaceutical Form kapsula, tvrda
Strength 10 mg
Packaging [MA Number for Packaging] 30 kapsula u blisteru, u kutiji  [HR-H-047281874-01]
Manufacturer Cenexi, Osny, Francuska;
Cenexi SAS, Fontenay-sous-Bois, Francuska
Marketing Authorisation Holder Actavis Group PTC ehf, Reykjavikurvegur 76-78, Hafnarfjordur, Island
Marketing Authorisation Date 19.04.2017
MA Period of Validity unlimited
Classification Number UP/I-530-09/16-02/109
Registration Number 381-12-01/14-17-09
Composition jedna tvrda kapsula sadrži 10 mg acitretina
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code D05BB02
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Educational materials
for healthcare professionals
Kontrolni popis i Izjava o razumijevanju rizika za liječnike, verzija 2
Kontrolni popis za ljekarnika, verzija 2
Educational materials
for patients / caregivers
Kartica za bolesnika, verzija 2

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o riziku od teratogenosti i mogućem razvoju neuropsihijatrijskih poremećaja prilikom primjene lijekova iz skupine retinoida (acitretin, adapalen, alitretinoin, beksaroten, izotretinoin, tazaroten i tretinoin) 10.12.2018 Belupo lijekovi i kozmetika d.d., Pliva Hrvatska d.o.o., Roche d.o.o.
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