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 |