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 |