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