Medicinal Products

Lenalidomid Alvogen 2,5 mg tvrde kapsule

Name Lenalidomid Alvogen 2,5 mg tvrde kapsule
Marketing Authorisation Number HR-H-821309332
Active Substance lenalidomid
Composition jedna kapsula sadrži 2,5 mg lenalidomida
Pharmaceutical Form kapsula, tvrda
Packaging [MA Number for Packaging] 7 kapsula u blisteru, u kutiji  [HR-H-821309332-01]
21 kapsula u blisteru, u kutiji  [HR-H-821309332-02]
Manufacturer Pharmadox Healthcare Limited, Paola PLA, Malta
S.C Labormed - Pharma SA, Bukurešt, Rumunjska
Marketing Authorisation Holder Alvogen Pharma Trading Europe EOOD, 86A Bulgaria blvd., Sofija, Bugarska
Marketing Authorisation Date 15.07.2020
MA Period of Validity 30.04.2023
MA Revocation Date 03.03.2022*
Classification Number UP/I-530-09/17-01/160
Registration Number 381-12-01/30-20-20
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 Trajni prekid opskrbe
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Vodic za zdravstvene radnike verzija 4
Obrazac pristanka bolesnika, verzija 3
Obrazac za prijavu trudnoće, verzija 2
Educational materials
for patients / caregivers
Kartica za bolesnika, verzija 3
Vodic za bolesnike verzija 4

*Note

Marketing authorisation has been revoked by request of the marketing authorisation holder.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.

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