Medicinal Products

Lenalidomid Alpha-Medical 10 mg tvrde kapsule

Name Lenalidomid Alpha-Medical 10 mg tvrde kapsule
Marketing Authorisation Number HR-H-652171057
Active Substance lenalidomid
Composition jedna kapsula sadrži 10 mg lenalidomida
Pharmaceutical Form kapsula, tvrda
Packaging [MA Number for Packaging] 7 kapsula u blisteru, u kutiji  [HR-H-652171057-01]
14 kapsula u blisteru, u kutiji  [HR-H-652171057-02]
21 kapsula u blisteru, u kutiji  [HR-H-652171057-03]
28 kapsula u blisteru, u kutiji  [HR-H-652171057-04]
42 kapsule u blisteru, u kutiji  [HR-H-652171057-05]
Manufacturer Synthon Hispania S.L., Barcelona, Španjolska
Synthon BV, Nijmegen, Nizozemska
Orion Corporation, Orion Pharma, Espoo, Finska
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska
Marketing Authorisation Date 14.09.2018
MA Period of Validity 14.09.2023
MA Revocation Date 08.07.2022*
Classification Number UP/I-530-09/17-01/167
Registration Number 381-12-01/38-18-06
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 Da
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Vodič za zdravstvene radnike, verzija 4
Obrazac pristanka bolesnika, verzija 3
Obrazac za prijavu trudnoće, verzija 2
Educational materials
for patients / caregivers
Vodič za bolesnike, verzija 4
Kartica za bolesnika, verzija 3


Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.