MABTHERA

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1	Rituximab UNII 4F4X42SYQ6 - RITUXIMAB
	Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes. The antigen is expressed on >95% of all B cell non-Hodgkin’s lymphomas.
	Read more about Rituximab

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A6-0505	Solution for injection	MABTHERA 1400MG SOLUTION FOR SUBCUTANEOUS INJECTION INJ_SOL 1400 mg/11.7 mL 1 x 15ml	Type I USP/Ph. Eur. colourless glass vial sealed with butyl rubber stopper laminated with fluoro resin film and crimped with an aluminum overseal fitted with a plastic flip-off disk x 15 mL (Box of 1's)	06/06/2023

Medicine classification

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

ATC Group		Classification
L01FA01	Rituximab	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FA CD20 (Clusters of Differentiation 20) inhibitors
Discover more medicines within L01FA01

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	10703H, 10708N, 10709P, 10710Q, 10719E, 10720F, 10741H, 10742J, 11942M, 11988Y
BR	Câmara de Regulação do Mercado de Medicamentos	529203301153217, 529203302151218, 529216020026403
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	24.240-1-05-11, 36-MBE-1215
EE	Ravimiamet	1041398, 1041400, 1645534, 1720437
ES	Centro de información online de medicamentos de la AEMPS	198067003, 98067001, 98067002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	494237, 494286, 545104
FR	Base de données publique des médicaments	62002638, 65314657, 65348481
GB	Medicines & Healthcare Products Regulatory Agency	247803, 76960, 76972
HK	Department of Health Drug Office	46231, 46232, 59248, 59249, 64699, 65562
IL	מִשְׂרַד הַבְּרִיאוּת	4944, 4945, 7851
IT	Agenzia del Farmaco	033315019, 033315021, 033315033
LT	Valstybinė vaistų kontrolės tarnyba	1011145, 1011146, 1074075, 1080831
NG	Registered Drug Product Database	A6-0505
NL	Z-Index G-Standaard	14219557, 14219565
NL	Z-Index G-Standaard, PRK	117005, 51004, 51012
NZ	Medicines and Medical Devices Safety Authority	15906, 17802, 8039
PL	Rejestru Produktów Leczniczych	100086903, 100325213, 100383848, 100383854
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64385001, W64386001, W64387001, W66651001
SG	Health Sciences Authority	09946P, 13718P, 15023P
TN	Direction de la Pharmacie et du Médicament	6993141H, 6993142H, 6993143H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699505763361, 8699505763378, 8699505772813
ZA	Health Products Regulatory Authority	32/26/0578, 32/26/0579, 49/30.1/0466