Lenalidomid Teva 5 mg tvrde kapsule
Name | Lenalidomid Teva 5 mg tvrde kapsule |
---|---|
Marketing Authorisation Number | HR-H-721228753 |
Active Substance | lenalidomidklorid hidrat |
Composition | jedna kapsula sadrži lenalidomidklorid hidrat što odgovara 5 mg lenalidomida |
Pharmaceutical Form | kapsula, tvrda |
Manufacturer | Teva Operations Poland Sp. z o.o., Krakow, Poljska Merckle GmbH, Blaubeuren, Njemačka 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-530-09/22-02/159 |
Registration Number | 381-12-01/154-23-02 |
Prescription | Medicinal product subject to medical prescription |
Type of prescription | ograničeni recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | L04AX04 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
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 |
Educational materials for patients / caregivers |
Kartica za bolesnika, verzija 3 Vodic za bolesnike, verzija 4 |