Medicinal Products

Tresuvi 5 mg/ml otopina za infuziju

Name Tresuvi 5 mg/ml otopina za infuziju
Marketing Authorisation Number HR-H-777980453
Active Substance treprostinilum
Composition jedan ml otopine sadrži 5 mg treprostinila u obliku treprostinilnatrija
Pharmaceutical Form otopina za infuziju
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
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
Summary of risk management plan 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
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