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 | treprostinilnatrij |
| Composition | jedan ml sadrži 5 mg treprostinila u obliku treprostinilnatrija |
| Pharmaceutical Form | otopina za infuziju |
| 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 |
| MA Revocation Date | 04.08.2023* |
| Classification Number | UP/I-530-09/18-01/148 |
| Registration Number | 381-12-01/38-19-06 |
| 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 | Trajni prekid opskrbe |
| 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 |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
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. |
