| Code | 50512 | ||||||||||
| MA number | EU/1/08/443/001 | ||||||||||
| Product Form: | cps dur 28x50 mg (blis.PVC/PCTFE/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Bristol-Myers Squibb Pharma EEIG , Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 60 | ||||||||||
| Container: | blister PVC/PCTFE/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application |
| MA issued: | 16.04.2008 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC Thalidomide Celgene.pdf
|
| Dokument: |
Thalidomide Prirucka pre pacienta 2024.pdf
|
| Dokument: |
Thalidomide Karta pacienta 2024.pdf
|
| Dokument: |
Thalidomide Prirucka pre zdravotnickych pracovnikov 2024.pdf
|
| Dokument: |
Thalidomide Formular informovanosti o rizikach 2024.pdf
|
| Safety feature | Yes |
| Data update: | 07.08.2023 |
