| Name |
Daptomicin MIP 350 mg prašak za otopinu za injekciju/infuziju |
| Marketing Authorisation Number |
HR-H-708408283 |
| Active Substance |
daptomicin |
| Composition |
jedna bočica s praškom sadrži 350 mg daptomicina |
| Pharmaceutical Form |
Prašak za otopinu za injekciju / infuziju |
| Manufacturer |
MIP Pharma GmbH, St. Ingbert, Njemačka |
| Marketing Authorisation Holder |
MIP Pharma Croatia d.o.o., Mihanovićeva 14, Zagreb, Hrvatska |
| Marketing Authorisation Date |
24.01.2025 |
| MA Period of Validity |
24.01.2030 |
| Classification Number |
UP/I-530-09/23-01/90 |
| Registration Number |
381-12-01/286-25-08 |
| 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 |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
