Lenalidomid Teva 2,5 mg tvrde kapsule
Name | Lenalidomid Teva 2,5 mg tvrde kapsule |
---|---|
Marketing Authorisation Number | HR-H-980649384 |
Active Substance | lenalidomidklorid hidrat |
Composition | jedna kapsula sadrži lenalidomidklorid hidrat što odgovara 2,5 mg lenalidomida |
Pharmaceutical Form | kapsula, tvrda |
Packaging [MA Number for Packaging] | 7 kapsula u blisteru, u kutiji [HR-H-980649384-01] 7 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-980649384-02] 21 kapsula u blisteru, u kutiji [HR-H-980649384-03] 21 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-980649384-04] 63 kapsula u blisteru, u kutiji [HR-H-980649384-05] 63 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-980649384-06] |
Manufacturer | Teva Operations Poland Sp. z o.o., Krakow, Poljska Merckle GmbH, Blaubeuren, 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 | 23.05.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/22-02/158 |
Registration Number | 381-12-01/154-23-04 |
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 |
Obrazac za prijavu trudnoće, verzija 2 Vodic za zdravstvene radnike, verzija 4 Obrazac pristanka bolesnika, verzija 3 |