| Code | 9394A | ||||||||||
| MA number | EU/1/09/546/007 | ||||||||||
| Product Form: | sol iru 1x1 ml/100 mg (striek.napl.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Janssen Biologics B.V., Netherland | ||||||||||
| 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: | 01.10.2009 |
| 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 |
