Remifentanil hameln 5 mg prašak za koncentrat za otopinu za injekciju/infuziju
| Name | Remifentanil hameln 5 mg prašak za koncentrat za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-013761777 |
| Active Substance | remifentanilklorid |
| Composition | svaka bočica sadrži remifentanilklorid što odgovara 5 mg remifentanila svaki ml otopine za injekciju/infuziju sadrži 1 mg remifentanila nakon rekonstitucije |
| Pharmaceutical Form | Prašak za koncentrat za otopinu za injekciju / infuziju |
| Manufacturer | hameln rds s.r.o., Modra, Slovačka
Siegfried Hameln GmbH, Hameln, Njemačka |
| Marketing Authorisation Holder | hameln pharma gmbH, Inselstrasse 1, Hameln, Njemačka |
| Marketing Authorisation Date | 04.02.2022 |
| MA Period of Validity | 04.02.2027 |
| Classification Number | UP/I-530-09/21-01/151 |
| Registration Number | 381-12-01/154-22-03 |
| Prescription | na recept |
| Type of prescription | poseban i ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N01AH06 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
