Simponi 50 mg solution for injection in pre-filled pen

Licence status
Authorised: 01/10/2009
Active substances
Golimumab
Dosage Form
Solution for injection
Licence number
EU/1/09/546/1-4
Licence holder
Janssen Biologics B.V.

Product documents

Licence information

ATC code
L04AB Tumor necrosis factor alpha (TNF-) inhibitors, L04AB06 golimumab
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
01/10/2009

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