| Name |
Azolar 15 mg tablete |
| Marketing Authorisation Number |
HR-H-911811259 |
| Active Substance |
aripiprazol |
| Composition |
jedna tableta sadrži 15 mg aripiprazola |
| Pharmaceutical Form |
tableta |
| Manufacturer |
Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
| Marketing Authorisation Holder |
Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
| Marketing Authorisation Date |
27.01.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/19-02/67 |
| Registration Number |
381-12-01/30-20-02 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N05AX12 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
