| Code | 0830D | ||||||||||
| MA number | EU/1/09/546/009 | ||||||||||
| Product Form: | sol ira 1x0,45 ml/45 mg (pero napl.skl. - VarioJect) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| Therapeutic Class: | 29 - ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 18.02.2019 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC_Simponi_zmeny v navode na pouzitie_28_07_2023.pdf
|
| Safety feature | Yes |
| Data update: | 12.03.2020 |
