Medicinal Products

Lenalidomid Teva 20 mg tvrde kapsule

Name Lenalidomid Teva 20 mg tvrde kapsule
Marketing Authorisation Number HR-H-526586946
Active Substance lenalidomidklorid hidrat
Composition jedna kapsula sadrži lenalidomidklorid hidrat što odgovara 20 mg lenalidomida
Pharmaceutical Form kapsula, tvrda
Packaging [MA Number for Packaging] 21 kapsula u blisteru, u kutiji  [HR-H-526586946-01]
21 kapsula u blisteru s jediničnom dozom, u kutiji  [HR-H-526586946-02]
Manufacturer Teva Operations Poland Sp. z o.o., Krakow, Poljska
Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka
Teva Pharma B.V., Haarlem, Nizozemska
Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Marketing Authorisation Holder Teva B.V., Swensweg 5, Haarlem, Nizozemska
Marketing Authorisation Date 27.07.2018
MA Period of Validity 27.07.2023
MA Revocation Date 10.05.2022*
Classification Number UP/I-530-09/17-01/176
Registration Number 381-12-01/30-18-03
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
Obrazac za prijavu trudnoće, verzija 2
Vodic za zdravstvene radnike, verzija 4
Obrazac pristanka bolesnika, verzija 3
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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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