Dacepton 10 mg/ml otopina za injekciju u ulošku
Name | Dacepton 10 mg/ml otopina za injekciju u ulošku |
---|---|
Marketing Authorisation Number | HR-H-428746321 |
Active Substance | apomorfinklorid hemihidrat |
Composition | 1 ml otopine za injekciju sadrži 10 mg apomorfinklorid hemihidrata |
Pharmaceutical Form | otopina za injekciju u ulošku |
Manufacturer | Ever Neuro Pharma GmbH, Unterach am Attersee, Austrija Ever Pharma Jena GmbH, Jena, Njemačka Ever Pharma Jena GmbH, Jena, Njemačka |
Marketing Authorisation Holder | Ever Neuro Pharma GmbH, Oberburgau 3, Unterach am Attersee, Austrija |
Marketing Authorisation Date | 26.11.2020 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/20-02/60 |
Registration Number | 381-12-01/30-20-03 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | N04BC07 |
Medicinal product marketed in the Croatia | Ne |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |