| Code | 9488D | ||||||||||
| MA number | 59/0016/22-S | ||||||||||
| Product Form: | cps dur 7x25 mg (blis.PVC/PCTFE/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 13.02.2022 |
| Validity: | 13.02.2027 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Lignaron_06.2024.pdf
|
| PIL: |
PIL_Lignaron_06.2024.pdf
|
| Dokument: |
Lenalidomid_Príručka pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
Lenalidomid_Príručka pre pacientov.pdf
|
| Dokument: |
Lenalidomid_Karta_pacienta.pdf
|
| Dokument: |
Lenalidomid_Formulár informovanosti o rizikách.pdf
|
| Safety feature | Yes |
| Data update: | 15.02.2022 |
