Acarizax 12 SQ-HDM sublingvalni liofilizat
| Name | Acarizax 12 SQ-HDM sublingvalni liofilizat |
|---|---|
| Marketing Authorisation Number | HR-H-514558232 |
| Active Substance | standardiziran ekstrakt alergena grinja kućne prašine Dermatophagoides pteronyssinus standardiziran ekstrakt alergena grinja kućne prašine Dermatophagoides farinae |
| Composition | standardiziran ekstrakt alergena grinja kućne prašine Dermatophagoides pteronyssinus i Dermatophagoides farinae, 12 SQ-HDM po oralnom liofilizatu |
| Pharmaceutical Form | Sublingvalni liofilizat |
| Manufacturer | ALK-Abelló S.A., Madrid, Španjolska |
| Marketing Authorisation Holder | ALK-Abelló A/S, Boge Allé 6-8, Horsholm, Danska |
| Marketing Authorisation Date | 14.05.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/253 |
| Registration Number | 381-12-01/70-20-04 |
| 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 | V01AA03 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
