Medicinal Products

Deksametazon hameln 4 mg/ml otopina za injekciju

Name Deksametazon hameln 4 mg/ml otopina za injekciju
Marketing Authorisation Number HR-H-420625303
Active Substance natrijev deksametazonfosfat
Composition 1 ml otopine sadrži 4 mg deksametazonfosfata (u obliku natrijevog deksametazonfosfata) 2 ml otopine sadrži 8 mg deksametazonfosfata (u obliku natrijevog deksametazonfosfata)
Pharmaceutical Form otopina za injekciju
Manufacturer HBM Pharma s.r.o., Martin, Slovačka
Siegfried Hameln GmbH, Hameln, Njemačka
hameln rds s.r.o., Modra, Slovačka
Marketing Authorisation Holder hameln pharma GmbH, Inselstrasse 1, Hameln, Njemačka
Marketing Authorisation Date 09.06.2021
MA Period of Validity 09.06.2026
Classification Number UP/I-530-09/19-01/125
Registration Number 381-12-01/154-21-06
Prescription Medicinal product subject to medical prescription
Type of prescription ograničeni recept
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code H02AB02
Marketing status stavljeno u promet
Shortage status nema nestašice
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download

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