Operil 0,5 mg/ml sprej za nos, otopina za odrasle
| Name | Operil 0,5 mg/ml sprej za nos, otopina za odrasle |
|---|---|
| Marketing Authorisation Number | HR-H-403078134 |
| Active Substance | oksimetazolinklorid |
| Composition | 1 ml spreja za nos, otopine sadrži 0,5 mg oksimetazolinklorida što odgovara 0,44 mg oksimetazolina |
| Pharmaceutical Form | sprej za nos, otopina |
| Manufacturer | Laboratori Fundacio Dau, Barcelona, Španjolska Laboratorios Alcalá Farma S.L., Alcala de Henares, Madrid, Španjolska |
| Marketing Authorisation Holder | Phoenix Labs Unlimited Company, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Irska |
| Marketing Authorisation Date | 31.01.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/758 |
| Registration Number | 381-12-01/154-23-19 |
| Prescription | Medicinal product not subject to medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | allowed |
| ATC Code | R01AA05 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |