Code | 7381D | ||||||||||
MA number | 59/0116/21-S | ||||||||||
Product Form: | cps dur 28x0,5 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Bausch Health Ireland Limited , Ireland | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 24 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 14.05.2021 |
Validity: | 14.05.2026 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Gaxenim 0,5 mg_09.2022.pdf |
SPC: | SPC_Gaxenim 0,5 mg_06.2024.pdf |
Safety feature | Yes |
Data update: | 08.09.2021 |