Lenalidomid Sandoz 2,5 mg tvrde kapsule
| Name | Lenalidomid Sandoz 2,5 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-393010825 |
| Active Substance | lenalidomidum |
| Pharmaceutical Form | kapsula, tvrda |
| Strength | 2,5 mg |
| Packaging [MA Number for Packaging] | 7 kapsula u blisteru, u kutiji [HR-H-393010825-01] 14 kapsula u blisteru, u kutiji [HR-H-393010825-02] 21 kapsula u blisteru, u kutiji [HR-H-393010825-03] 28 kapsula u blisteru, u kutiji [HR-H-393010825-04] 42 kapsule u blisteru, u kutiji [HR-H-393010825-05] |
| 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 |
| Marketing Authorisation Date | 09.10.2018 |
| MA Period of Validity | 09.10.2023 |
| Classification Number | UP/I-530-09/17-01/156 |
| Registration Number | 381-12-01/14-18-05 |
| Composition | svaka kapsula sadrži 2,5 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 | Ne |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 3 Kontrolni popis za propisivače, verzija 2 Obrazac za prijavu trudnoće, verzija 2 Obrazac pristanka bolesnika, verzija 2 |
| Educational materials for patients / caregivers |
Vodič za bolesnike, verzija 3 Kartica za bolesnika, verzija 2 |
