| Code | 7010A | ||||||||||
| MA number | EU/1/13/838/002 | ||||||||||
| Product Form: | tbl flm 28x14 mg (blis.Al/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Sanofi Winthrop Industrie, France | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister Al/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: | 26.08.2013 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Teriflunomid_Karta pre pacienta.pdf
|
| Dokument: |
Teriflunomid_Pokyny pre zdravotníckych pracovníkov.pdf
|
| Safety feature | Yes |
| Data update: | 09.04.2025 |
