| Code | 2749D | ||||||||||
| MA number | 59/0340/19-S | ||||||||||
| Product Form: | lyo slg 30x12 SQ-Bet (blis.Al/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | ALK-Abelló A/S, Denmark | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 60 | ||||||||||
| Container: | blister Al/Al | ||||||||||
| Route of admin.: | Sublingual use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 12.11.2019 |
| PIL: |
PIL_ITULAZAX_03.2023.pdf
|
| SPC: |
SPC_ITULAZAX_10.2023.pdf
|
| Safety feature | No |
| Data update: | 28.05.2024 |
