Medicinal Products

Lenalidomid Teva 5 mg tvrde kapsule

Name Lenalidomid Teva 5 mg tvrde kapsule
Marketing Authorisation Number HR-H-721228753
Active Substance lenalidomidum
Pharmaceutical Form kapsula, tvrda
Strength 5 mg
Packaging [MA Number for Packaging] 7 kapsula u blisteru, u kutiji  [HR-H-721228753-01]
7 kapsula u blisteru s jediničnom dozom, u kutiji  [HR-H-721228753-02]
21 kapsula u blisteru, u kutiji  [HR-H-721228753-03]
21 kapsula u blisteru s jediničnom dozom, u kutiji  [HR-H-721228753-04]
Manufacturer Teva UK Ltd., Eastbourne, East Sussex, Ujedinjeno Kraljevstvo;
Pliva Hrvatska d.o.o., Zagreb, Republika Hrvatska;
Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka;
Teva Pharma B.V., Haarlem, Nizozemska;
Teva Operations Poland Sp. z o.o., Krakow, Poljska
Marketing Authorisation Holder Teva B.V., Swensweg 5, Haarlem, Nizozemska
Marketing Authorisation Date 27.07.2018
MA Period of Validity 27.07.2023
Classification Number UP/I-530-09/17-01/172
Registration Number 381-12-01/30-18-03
Composition jedna kapsula sadrži lenalidomidklorid hidrat što odgovara 5 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 Da
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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