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 B.V., Utrecht, Nizozemska |
Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
Marketing Authorisation Date | 09.01.2020 |
MA Period of Validity | 09.01.2025 |
Classification Number | UP/I-530-09/18-01/122 |
Registration Number | 381-12-01/30-20-04 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J01XX09 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |