RoACTEMRA

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

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 more about Tocilizumab

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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