Tresuvi 5 mg/ml otopina za infuziju
| Name | Tresuvi 5 mg/ml otopina za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-777980453 |
| Active Substance | treprostinilum |
| Pharmaceutical Form | otopina za infuziju |
| Strength | 5 mg/ml |
| Packaging [MA Number for Packaging] | 1 bočica s 10 ml otopine, u kutiji [HR-H-777980453-01] |
| Manufacturer | Amomed Pharma GmbH, Beč, Austrija |
| Marketing Authorisation Holder | Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, Purkersdorf, Austrija |
| Marketing Authorisation Date | 18.01.2021 |
| MA Period of Validity | 18.01.2026 |
| Classification Number | UP/I-530-09/19-01/236 |
| Registration Number | 381-12-01/70-21-02 |
| Composition | jedan ml otopine sadrži 5 mg treprostinila u obliku treprostinilnatrija |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B01AC21 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 1 |
| Educational materials for patients / caregivers |
Upitnik za bolesnika, verzija 1 Brošura za bolesnika, verzija 1 |
