Lenalidomid Alvogen 10 mg tvrde kapsule
Name | Lenalidomid Alvogen 10 mg tvrde kapsule |
---|---|
Marketing Authorisation Number | HR-H-760591329 |
Active Substance | lenalidomidum |
Pharmaceutical Form | kapsula, tvrda |
Strength | 10 mg |
Packaging [MA Number for Packaging] | 21 kapsula u blisteru, u kutiji [HR-H-760591329-01] |
Manufacturer | Pharmadox Healthcare Limited, Paola PLA, Malta
Pharmacare Premium Ltd., Birzebbugia, 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 |
Classification Number | UP/I-530-09/17-01/163 |
Registration Number | 381-12-01/30-20-17 |
Composition | jedna kapsula sadrži 10 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 |
Vodic za zdravstvene radnike verzija 4 Obrazac pristanka bolesnika, verzija 3 Obrazac za prijavu trudnoće, verzija 2 |
Educational materials for patients / caregivers |
Vodic za bolesnike verzija 4 Kartica za bolesnika, verzija 3 |