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. |
