Lenalidomid Teva 25 mg tvrde kapsule
| Name | Lenalidomid Teva 25 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-401107633 |
| Active Substance | lenalidomidklorid hidrat |
| Composition | jedna kapsula sadrži lenalidomidklorid hidrat što odgovara 25 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-530-09/22-02/162 |
| Registration Number | 381-12-01/154-23-02 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L04AX04 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 5 Obrazac za prijavu trudnoće, verzija 3, travanj 2025 Obrazac potvrde bolesnice u reproduktivnoj dobi, verzija 1 travanj 2025 Obrazac potvrde bolesnice koja nije u reproduktivnoj dobi, verzija 1 travanj 2025 Obrazac potvrde muškog bolesnika, verzija 1, travanj 2025 |
| Educational materials for patients / caregivers |
Kartica za bolesnika, verzija 4, travanj 2025 Vodič za bolesnice koje nisu u reproduktvnoj dobi, verzija 1 Vodič za bolesnice u reproduktivnoj dobi, verzija 1 Vodič za muške bolesnike, verzija 1 |
