Daptomicin Accordpharma 500 mg prašak za otopinu za injekciju/infuziju
| Name | Daptomicin Accordpharma 500 mg prašak za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-001703757 |
| Active Substance | daptomicin |
| Composition | jedna bočica s praškom sadrži 500 mg daptomicina jedan ml otopine nakon rekonstitucije s 10 ml otopine natrijevog klorida 9 mg/ml (0,9%) sadrži 50 mg daptomicina |
| Pharmaceutical Form | Prašak za otopinu za injekciju / infuziju |
| Manufacturer | Laboratori Fundacio Dau, Barcelona, Španjolska Pharmadox Healthcare Limited, Paola, Malta Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Accord Healthcare Single Member S.A., Lamia, Grčka |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 12.08.2025 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/24-02/03 |
| Registration Number | 381-12-01/286-25-09 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J01XX09 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
