| Code | 9349E | ||||||||||
| MA number | EU/1/24/1904/001 | ||||||||||
| Product Form: | sol inj 1x1,7 ml/120 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Celltrion Healthcare Hungary Kft., Hungary | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(4) similar biological application |
| MA issued: | 14.02.2025 |
| Validity: | 14.02.2030 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Denosumab 120 mg_Zoznam držiteľov.pdf
|
| Dokument: |
Denosumab 120 mg_Karta pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 20.03.2025 |
