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PRODUCT DETAIL

Simponi 100 mg injekčný roztok naplnený v injekčnom pere

Code 9392A
MA number EU/1/09/546/005
Product Form: sol ira 1x1 ml/100 mg (pero napl.skl. - SmartJect)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 29 - ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AB Tumor necrosis factor alpha (TNF-alpha) inhibitors
L04AB06 Golimumab
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
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