Atosiban EVER Pharma 37,5 mg/5 ml koncentrat za otopinu za infuziju
| Name | Atosiban EVER Pharma 37,5 mg/5 ml koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-338807737 |
| Active Substance | atosibanacetat |
| Composition | Jedna bočica od 5 ml otopine sadrži 37,5 mg atosibana (u obliku atosibanacetata). |
| Pharmaceutical Form | Koncentrat za otopinu za infuziju |
| Manufacturer | Ever Pharma Jena GmbH, Jena, Njemačka
Ever Pharma Jena GmbH, Jena, Njemačka |
| Marketing Authorisation Holder | EVER Valinject GmbH, Oberburgau 3, Unterach am Attersee, Austrija |
| Marketing Authorisation Date | 13.02.2026 |
| MA Period of Validity | 13.02.2031 |
| Classification Number | UP/I-530-09/25-01/248 |
| Registration Number | 381-12-01/171-26-06 |
| 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 | G02CX01 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |