Medicinal Products

Roaccutane 10 mg meke kapsule

Name Roaccutane 10 mg meke kapsule
Marketing Authorisation Number HR-H-462694255
Active Substance isotretinoinum
Pharmaceutical Form kapsula, meka
Strength 10 mg
Packaging [MA Number for Packaging] 30 kapsula u blisteru, u kutiji  [HR-H-462694255-01]
Manufacturer Roche Pharma AG, Grenzach-Wyhlen, Njemačka
Marketing Authorisation Holder Roche d.o.o., Ulica grada Vukovara 269a, Zagreb
Marketing Authorisation Date 16.06.2016
MA Period of Validity unlimited
Classification Number UP/I-530-09/15-02/339
Registration Number 381-12-01/30-16-06
Composition jedna meka kapsula sadrži 10 mg izotretinoina
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code D10BA01
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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