| Code | 5603E | ||||||||||
| MA number | EU/1/23/1785/012 | ||||||||||
| Product Form: | cps dur 21x1x3 mg (blis.PVC/PCTFE/Al - jednotk.bal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PCTFE/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 16.02.2024 |
| Validity: | 16.02.2029 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Pomalidomid_Formulár informovanosti o rizikách.pdf
|
| Dokument: |
Pomalidomid_Karta pacienta.pdf
|
| Dokument: |
Pomalidomid_Prirucka pre pacientov.pdf
|
| Dokument: |
Pomalidomid_Prirucka pre zdravotnickych pracovnikov.pdf
|
| Safety feature | Yes |
| Data update: | 21.02.2024 |
