| Name |
Itulazax 12 SQ-Bet sublingvalni liofilizat |
| Marketing Authorisation Number |
HR-H-926972641 |
| Active Substance |
standardizirani ekstrakt alergena peludi bijele breze |
| Composition |
jedan sublingvalni liofilizat sadrži 12 SQ-Bet standardiziranog alergena ekstrakta peludi bijele breze (Betula verrucosa) |
| 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 |
18.12.2023 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/23-02/147 |
| Registration Number |
381-12-01/286-23-05 |
| 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 |
V01AA05 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
