Code | 6381D | ||||||||||
MA number | EU/1/19/1414/006 | ||||||||||
Product Form: | tbl flm 98x2 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: |
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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 |
Validity: | 13.01.2025 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | Mayzent_Príručka pre pacienta.pdf |
Dokument: | Mayzent_Kontrolný zoznam.pdf |
Safety feature | Yes |
Data update: | 08.02.2021 |