Daptomicin Accord Healthcare 350 mg prašak za otopinu za injekciju/infuziju
| Name | Daptomicin Accord Healthcare 350 mg prašak za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-601578957 |
| Active Substance | daptomicin |
| Composition | jedna bočica sadrži 350 mg daptomicina |
| Pharmaceutical Form | Prašak za otopinu za injekciju / infuziju |
| Manufacturer | Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska
Pharmadox Healthcare Limited, Paola, Malta Laboratori Fundacio Dau, Barcelona, Španjolska |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 18.07.2023 |
| MA Period of Validity | 18.07.2028 |
| Classification Number | UP/I-530-09/21-01/291 |
| Registration Number | 381-12-01/154-23-09 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J01XX09 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
