Medicinal Products

Lenalidomid Teva 7,5 mg tvrde kapsule

Name Lenalidomid Teva 7,5 mg tvrde kapsule
Marketing Authorisation Number HR-H-661728014
Active Substance lenalidomidklorid hidrat
Composition jedna kapsula sadrži lenalidomidklorid hidrat što odgovara 7,5 mg lenalidomida
Pharmaceutical Form kapsula, tvrda
Packaging [MA Number for Packaging] 21 kapsula u blisteru, u kutiji  [HR-H-661728014-01]
21 kapsula u blisteru s jediničnom dozom, u kutiji  [HR-H-661728014-02]
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
Classification Number UP/I-530-09/17-01/173
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 Ne
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Kontrolni popis za propisivače, verzija 2
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
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