| Code | 5168E | ||||||||||
| MA number | 59/0274/23-S | ||||||||||
| Product Form: | cps end 100x120 mg (fľ.HDPE s PP/HDPE uzáverom) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 03.01.2024 |
| Validity: | 03.01.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Arbicen_12_2023.pdf
|
| SPC: |
SPC_Arbicen_12_2023.pdf
|
| Safety feature | Yes |
| Data update: | 10.01.2024 |
