ACTEMRA

This brand name is authorized in Nigeria. It is also authorized in Australia, Brazil, Canada, Ecuador, Hong Kong SAR China, Israel, Japan, New Zealand, Singapore, South Africa, Tunisia, Turkey, United States.

Active ingredients

The drug ACTEMRA 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

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A6-100066	Injection	Actemra 400 mg INJ_SOL_CONC 400 mg/20 mL 20 mL x 1’s; 20 mL x 4’s (in vials)	Concentrate for solution for IV infusion in single-dose 20-mL vial. A preservative-free, sterile clear, colourless to pale yellow solution	18/12/2022
A6-100067	Injection	Actemra 200 mg INJ_SOL_CONC 200 mg/10mL 10 mL x 1’s; 10 mL x 4’s (in vials)	Concentrate for solution for IV infusion in single-dose 10-mL vial. A preservative-free, sterile clear, colourless to pale yellow solution	18/12/2022
A6-100068	Injection	Actemra 80 mg INJ_SOL_CONC 80 mg/4 mL 4 mL x 1’s; 4 mL x 4’s (in vials)	Concentrate for solution for IV infusion in single-dose 4-mL vial. A preservative-free, sterile clear, colourless to pale yellow solution	18/12/2022
A6-100070	Injection	Actemra 162 mg INJ_SOL 162 mg/0.9 mL 0.9 mL x 4’s (in pre-filled syringed)	Solution for injection in single-dose pre-filled syringe for SC injection. A preservative-free, sterile clear, colourless to pale yellow solution	19/02/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ACTEMRA Solution for injection	MPI, US: SPL/PLR	FDA, National Drug Code (US)

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)
AU	Pharmaceutical Benefits Scheme	10056G, 10058J, 10060L, 10064Q, 10068X, 10071C, 10072D, 10073E, 10077J, 10078K, 10079L, 10081N, 10951J, 10954M, 11565Q, 11567T, 11720W, 11721X, 11722Y, 11725D, 11730J, 11734N, 11741Y, 11742B, 11743C, 11744D, 11748H, 11750K, 12083Y, 12084B, 12085C, 12086D, 12090H, 12094M, 12095N, 12099T, 12102Y, 12105D, 1419Q, 1423X, 1464C, 1476Q, 1481Y, 1482B, 9657G, 9658H, 9659J, 9671B, 9672C, 9673D
BR	Câmara de Regulação do Mercado de Medicamentos	529208501150212, 529208502157210, 529215110026303, 529220090026707, 529220090026807
CA	Health Products and Food Branch	02350092, 02350106, 02350114, 02424770, 02483327
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	202-MBE-0621, 28938-07-09
HK	Department of Health Drug Office	59200, 59201, 59202, 63771
IL	מִשְׂרַד הַבְּרִיאוּת	6415, 6416, 7772
JP	医薬品医療機器総合機構	6399421A1020, 6399421A2026, 6399421A3022, 6399421G1022, 6399421G2029
NG	Registered Drug Product Database	A6-100066, A6-100067, A6-100068, A6-100070
NZ	Medicines and Medical Devices Safety Authority	13435, 15812
SG	Health Sciences Authority	13723P, 14837P
TN	Direction de la Pharmacie et du Médicament	6993201H, 6993202H, 6993203H, 6993204H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699505762272, 8699505762289, 8699505762296, 8699505762302, 8699505762319, 8699505762326, 8699505952840
US	FDA, National Drug Code	50242-135, 50242-136, 50242-137, 50242-138, 50242-143
ZA	Health Products Regulatory Authority	43/30.1/0944, 43/30.1/0945, 43/30.1/0946, 49/30.1/0398