| Code | 8173D | ||||||||||
| MA number | 59/0209/21-S | ||||||||||
| Product Form: | tbl slg 3x100 IR+28x300 IR (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STALLERGENES, France | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Sublingual use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 13.08.2021 |
| Validity: | 13.08.2026 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_ACTAIR 100 IR_300 IR sublingválne tablety.03.2023.pdf
|
| PIL: |
PIL_ACTAIR 100 IR_300 IR sublingválne tablety.03.2023.pdf
|
| Safety feature | No |
| Data update: | 16.08.2021 |
