Code | 6358C | ||||||||||
MA number | EU/1/17/1232/001 | ||||||||||
Product Form: | cps dur 84x100 mg (blis.OPA/Al/PVC) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Gen.Orph, France | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | blister OPA/Al/PVC | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 10.11.2017 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 21.10.2022 |