Code | 5489D | ||||||||||
MA number | 59/0196/20-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: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | blister PVC/PE/PVDC/Al | ||||||||||
Route of admin.: | Oromucosal use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 17.09.2020 |
Validity: | 17.09.2025 |
MA renewed: | Renewal application submitted |
Pediatric warnings: | Yes |
SPC: | SPC_Bonaxon_04.2022.pdf |
PIL: | PIL_Bonaxon_04.2022.pdf |
Safety feature | Yes |
Data update: | 21.09.2020 |