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: |
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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 |