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Golimumab / Simponi®

   
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Simponi

100 mg/ml
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Simponi

100 mg/ml
Note: For full product details, please login.

Drug name: Simponi®

INN: Golimumab

API type: Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.

Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors

ATC code: L04AB06

General function:

Short description:

Original license holder:

Marketing authorisation numbers: EU/1/09/546/001 - 008

Marketing authorisation holder: Janssen Biologics B.V.; Einsteinweg 101; 2333 CB Leiden; The Netherlands

Name of the manufacturer of the biological active substance: Janssen Biologics B.V.; Einsteinweg 101; NL-2333 CB Leiden; The Netherlands

Name and address of the manufacturer responsible for batch release: Janssen Biologics B.V.; Einsteinweg 101; NL-2333 CB Leiden; The Netherlands

Max shelf life: 18 months

Storage conditions: 2°C – 8°C

List of excipients: Sorbitol(E420), L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, Water for injection