| Code | 09503 | ||||||||||
| MA number | EU/1/11/703/002 | ||||||||||
| Product Form: | sol inj 4x1,7 ml/120 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 13.07.2011 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC Xgeva ONJ update and Patient card 3 9 2015.pdf
|
| Dokument: |
DHPC Xgeva 2 9 2014.pdf
|
| Dokument: |
DHPC_XGEVA_hypokalciémia 31 8 2012.pdf
|
| Dokument: |
Denosumab 120 mg_Zoznam držiteľov.pdf
|
| Dokument: |
Denosumab 120 mg_Karta pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 09.05.2025 |
