Medicinal Products

Lenalidomid Alvogen 20 mg tvrde kapsule

Name Lenalidomid Alvogen 20 mg tvrde kapsule
Marketing Authorisation Number HR-H-668924151
Active Substance lenalidomidum
Pharmaceutical Form kapsula, tvrda
Strength 20 mg
Packaging [MA Number for Packaging] 21 kapsula u blisteru, u kutiji  [HR-H-668924151-01]
Manufacturer Pharmadox Healthcare Limited, Paola PLA, Malta;
Pharmacare Premium Ltd., Birzebbugia, Malta;
SC Labormed - Pharma SA, Bukurešt, Rumunjska
Marketing Authorisation Holder Alvogen Malta Operations (ROW) Ltd., Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann, Malta
Marketing Authorisation Date 30.04.2018
MA Period of Validity 30.04.2023
Classification Number UP/I-530-09/17-01/165
Registration Number 381-12-01/70-18-04
Composition jedna kapsula sadrži 20 mg lenalidomida
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L04AX04
Medicinal product marketed in the Croatia Ne
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Vodič za zdravstvene radnike, verzija 3
Kontrolni popis za propisivače, verzija 2
Obrazac za prijavu trudnoće, verzija 2
Obrazac pristanka bolesnika, verzija 2
Educational materials
for patients / caregivers
Vodič za bolesnike, verzija 3
Kartica za bolesnika, verzija 2
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