Medicinal Products

Treprostinil Alpha-Medical 1 mg/ml otopina za infuziju

Name Treprostinil Alpha-Medical 1 mg/ml otopina za infuziju
Marketing Authorisation Number HR-H-904933007
Active Substance treprostinilnatrij
Composition jedan ml sadrži 1 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-904933007-01]
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-530-09/18-01/146
Registration Number 381-12-01/38-19-11
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.
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