| Code | 0298F | ||||||||||
| MA number | 44/0142/25-S | ||||||||||
| Product Form: | sol inj 5x5 ml (liek.inj.skl) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Atnahs Pharma Netherlands B.V., Denmark | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 17.07.2025 |
| Validity: | 17.07.2030 |
| Pediatric contraindication: | Yes |
| PIL: |
PIL_Leuject 2 mg_ml injekčný roztok_06_2025.pdf
|
| SPC: |
SPC_Leuject 2 mg_ml injekčný roztok_06_2025.pdf
|
| Safety feature | Yes |
| Data update: | 18.07.2025 |
