Medicinal Products

Lenalidomid Sandoz 25 mg tvrde kapsule

Name Lenalidomid Sandoz 25 mg tvrde kapsule
Marketing Authorisation Number HR-H-987317425
Active Substance lenalidomidum
Pharmaceutical Form kapsula, tvrda
Strength 25 mg
Packaging [MA Number for Packaging] 7 kapsula u blisteru, u kutiji  [HR-H-987317425-01]
14 kapsula u blisteru, u kutiji  [HR-H-987317425-02]
21 kapsula u blisteru, u kutiji  [HR-H-987317425-03]
28 kapsula u blisteru, u kutiji  [HR-H-987317425-04]
42 kapsule u blisteru, u kutiji  [HR-H-987317425-05]
Manufacturer Synthon Hispania S.L., Barcelona, Španjolska;
Synthon BV, Nijmegen, Nizozemska;
Salutas Pharma GmbH., Barleben, Njemačka
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb
Marketing Authorisation Date 09.10.2018
MA Period of Validity 09.10.2023
Classification Number UP/I-530-09/17-01/159
Registration Number 381-12-01/14-18-03
Composition svaka kapsula sadrži 25 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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