RoACTEMRA

This brand name is authorized in Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom

Active ingredients

The drug RoACTEMRA contains one active pharmaceutical ingredient (API):

1 Tocilizumab
UNII I031V2H011 - TOCILIZUMAB

Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R). IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis. IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia.

Read about Tocilizumab

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
RoACTEMRA Concentrate for solution for infusion European Medicines Agency (EU) MPI, EU: SmPC
RoACTEMRA Solution for injection in pre-filled syringe European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L04AC07 Tocilizumab L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AC Interleukin inhibitors
Discover more medicines within L04AC07

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: EE Ravimiamet Identifier(s): 1399125, 1399136, 1399147, 1399158, 1399169, 1399170, 1647200, 1693874, 1769823, 1769834
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 08492001, 08492003, 108492007, 108492009
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 063926, 115769, 170062, 170085, 170107
Country: FR Base de données publique des médicaments Identifier(s): 67121308, 69107620, 69582503
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 160992, 160995, 160998, 247809, 354107
Country: IE Health Products Regulatory Authority Identifier(s): 88456, 88964
Country: IT Agenzia del Farmaco Identifier(s): 038937013, 038937025, 038937037, 038937049, 038937052, 038937064, 038937088, 038937090, 038937102, 038937114
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1035997, 1035998, 1035999, 1036000, 1036001, 1036002, 1073927, 1076160, 1086244, 1086245
Country: NL Z-Index G-Standaard, PRK Identifier(s): 116475, 150703, 88994, 89001
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100203645, 100309763
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W64403001, W64403002, W64403003, W64403004, W64403005, W64403006, W64404001

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