Abakavir/Lamivudin Mylan Pharma 600 mg/300 mg filmom obložene tablete
| Name | Abakavir/Lamivudin Mylan Pharma 600 mg/300 mg filmom obložene tablete |
|---|---|
| Former Name | Abakavir/lamivudin Vale 600 mg/300 mg filmom obložene tablete |
| Marketing Authorisation Number | HR-H-622715617 |
| Active Substance | abakavirsulfat lamivudin |
| Composition | jedna filmom obložena tableta sadrži 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 30 tableta u blisteru, u kutiji [HR-H-622715617-01] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-622715617-02] 90 tableta u blisteru, u kutiji [HR-H-622715617-03] 30 tableta u blisteru, u kutiji, 3 pakiranja u kutiji [HR-H-622715617-04] 30 tableta u bočici, u kutiji [HR-H-622715617-05] |
| Manufacturer | McDermott Laboratories Limited, t/a Gerard Laboratories, Dublin 13, Irska
Mylan Hungary Kft, Komárom, Mađarska Mylan Germany GmbH , Bad Homburg, Hesse, Njemačka |
| Marketing Authorisation Holder | Mylan Ireland Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Irska |
| Marketing Authorisation Date | 31.05.2019 |
| MA Period of Validity | 10.08.2023 |
| MA Revocation Date | 30.06.2023* |
| Classification Number | UP/I-530-09/15-01/321 |
| Registration Number | 381-12-01/30-19-23 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J05AR02 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), 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.
