Medicinal Products

Traneksamatna kiselina Alpha-Medical 100 mg/ml otopina za injekciju

Name Traneksamatna kiselina Alpha-Medical 100 mg/ml otopina za injekciju
Marketing Authorisation Number HR-H-250950979
Active Substance traneksamatna kiselina
Composition jedan ml otopine sadrži 100 mg traneksamatne kiseline
Pharmaceutical Form otopina za injekciju
Packaging [MA Number for Packaging] 10 ampula sa 5 ml otopine, u kutiji  [HR-H-250950979-01]
Manufacturer Formula Pharmazeutische und chemische Entwicklungs GmbH, Berlin, Njemačka
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska
Marketing Authorisation Date 30.11.2020
MA Period of Validity 30.11.2025
Classification Number UP/I-530-09/18-01/162
Registration Number 381-12-01/38-20-15
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code B02AA02
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download
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