Code | 5635C | ||||||||||
MA number | EU/1/17/1224/002 | ||||||||||
Product Form: | tbl flm 180x250 mg (blis.PVC/PCTFE/PVC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | SERB SAS, France | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 60 | ||||||||||
Container: | blister PVC/PCTFE/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 18.09.2017 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 04.07.2022 |