Deksametazon hameln 4 mg/ml otopina za injekciju
Name | Deksametazon hameln 4 mg/ml otopina za injekciju |
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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 |