| Code | 9915C | ||||||||||
| MA number | 59/0419/18-S | ||||||||||
| Product Form: | cps dur 7x5 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 19.12.2018 |
| PIL: |
PIL_Lenalidomid Glenmark_ 5mg_10mg_15mg_25mg_06.2023.pdf
|
| SPC: |
SPC_Lenalidomid Glenmark_ 5mg_10mg_15mg_25mg_09.2024.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: | 06.10.2023 |
