Lenalidomid Sandoz 5 mg tvrde kapsule
Name | Lenalidomid Sandoz 5 mg tvrde kapsule |
---|---|
Marketing Authorisation Number | HR-H-394924085 |
Active Substance | lenalidomid |
Composition | svaka kapsula sadrži 5 mg lenalidomida |
Pharmaceutical Form | kapsula, tvrda |
Packaging [MA Number for Packaging] | 7 kapsula u blisteru, u kutiji [HR-H-394924085-01] 14 kapsula u blisteru, u kutiji [HR-H-394924085-02] 21 kapsula u blisteru, u kutiji [HR-H-394924085-03] 28 kapsula u blisteru, u kutiji [HR-H-394924085-04] 42 kapsule u blisteru, u kutiji [HR-H-394924085-05] 7 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-394924085-06] 14 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-394924085-07] 21 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-394924085-08] 28 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-394924085-09] |
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, Hrvatska |
Marketing Authorisation Date | 21.04.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/22-02/186 |
Registration Number | 381-12-01/171-23-05 |
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 |