| Code | 2876B | ||||||||||
| MA number | EU/1/14/974/001 | ||||||||||
| Product Form: | cps dur 56x84 mg (blis.PETG/COC.PETG/PCTFE-Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Sanofi B.V., Netherland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/Aclar/PCTFE | ||||||||||
| 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: | 19.01.2015 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
CERDELGA_Príručka pre predpisujúceho lekára.pdf
|
| Dokument: |
CERDELGA_Karta pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 27.12.2019 |
