Treprostinil Alpha-Medical 5 mg/ml otopina za infuziju
Name | Treprostinil Alpha-Medical 5 mg/ml otopina za infuziju |
---|---|
Marketing Authorisation Number | HR-H-582627817 |
Active Substance | treprostinilum |
Pharmaceutical Form | otopina za infuziju |
Strength | 5 mg/ml |
Packaging [MA Number for Packaging] | 1 bočica s 20 ml otopine, u kutiji [HR-H-582627817-01] |
Manufacturer | Dr. Reddy's Laboratories (UK) Ltd., East Yorkshire, Ujedinjeno Kraljevstvo
Betapharm Arzneimittel GmbH, Augsburg, Bavaria, Njemačka |
Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
Marketing Authorisation Date | 14.11.2019 |
MA Period of Validity | 14.11.2024 |
Classification Number | UP/I-530-09/18-01/148 |
Registration Number | 381-12-01/38-19-06 |
Composition | jedan ml 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 |
Medicinal product marketed in the Croatia | Ne |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |
Educational materials for healthcare professionals |
Prezentacija za obuku zdravstvenih radnika, verzija 1 Obrazac događaja od posebnog značaja, verzija 1 Upitnik za bolesnika, verzija 1 |
Educational materials for patients / caregivers |
Vodič za bolesnike, verzija 1 Upitnik za bolesnika, verzija 1 |
Direct Healthcare Professional Communication
Name | Date | Download |
---|---|---|
Pismo zdravstvenim radnicima o dodatnim mjerama minimizacije rizika od infekcija krvi povezanih s kateterom, u slučaju propisivanja i primjene lijekova koji sadrže treprostinil intravenskim putem | 22.04.2020 | Alpha-Medical d.o.o., Ferrer Internacional S.A. |