Lenalidomid Pharmascience 25 mg tvrde kapsule
| Name | Lenalidomid Pharmascience 25 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-323736618 |
| Active Substance | lenalidomid |
| Composition | jedna kapsula sadrži 25 mg lenalidomida |
| Pharmaceutical Form | kapsula, tvrda |
| Manufacturer | Pharmadox Healthcare Limited, Paola, Malta
AdAlvo Limited, San Gwann, Malta |
| Marketing Authorisation Holder | Pharmascience International Limited, Lampousas, 1, Nicosia, Cipar |
| Marketing Authorisation Date | 21.01.2025 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 28.07.2026* |
| Classification Number | UP/I-530-09/24-02/140 |
| Registration Number | 381-12-01/70-25-03 |
| 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 | Not marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodic za zdravstvene radnike, verzija 5, travanj 2025 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 Vodic za bolesnice u reproduktivnoj dobi i njihove partnere, verzija 1 travanj 2025 Vodic za bolesnice koje nisu u reproduktvnoj dobi, verzija 1 travanj 2025 Vodic za muške bolesnike, verzija1, travanj 2025 |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act, only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
