| Code | 4001D | ||||||||||
| MA number | EU/1/19/1414/004 | ||||||||||
| Product Form: | tbl flm 84x0,25 mg (PA/Al/PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Novartis Europharm Limited, Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 13.01.2020 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Mayzent_Príručka pre pacienta.pdf
|
| Dokument: |
Mayzent_Kontrolný zoznam.pdf
|
| Safety feature | Yes |
| Data update: | 10.10.2024 |
