COPAXONE

This brand name is authorized in Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Glatiramer UNII 5M691HL4BO - GLATIRAMER ACETATE

Glatiramer is presumed to involve modulation of immune processes. Glatiramer is licensed for reduced frequency of relapses in relapsing-remitting multiple sclerosis. Read about Glatiramer

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
COPAXONE Solution for injection	Medicines & Healthcare Products Regulatory Agency (GB)	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
L03AX13	Glatiramer acetate	L Antineoplastic and immunomodulating agents → L03 Immunostimulants → L03A Immunostimulants → L03AX Other immunostimulants
Discover more medicines within L03AX13

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10416F
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 537500101151219, 537517120007103
Country: CA	Health Products and Food Branch	Identifier(s): 02245619, 02456915
Country: EE	Ravimiamet	Identifier(s): 1241244, 1346598, 1612279, 1612280, 1618196, 1671634, 1671645, 1859171
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 65983, 79515
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 018779, 414592
Country: FR	Base de données publique des médicaments	Identifier(s): 60082062, 67611486
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 298218, 82619
Country: IE	Health Products Regulatory Authority	Identifier(s): 88575, 88580
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6121, 7477, 8579
Country: IT	Agenzia del Farmaco	Identifier(s): 035418021, 035418060
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999440G1024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1004651, 1036975, 1070238, 1070239, 1070394, 1075312, 1075313, 1093374
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 380M2004
Country: NL	Z-Index G-Standaard	Identifier(s): 14927535
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 124346, 74284
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 11109, 17956, 21061
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100172867, 100333371
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W62547001, W62547002, W62547003
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699638950478, 8699638953967
Country: US	FDA, National Drug Code	Identifier(s): 68546-317, 68546-325
Country: ZA	Health Products Regulatory Authority	Identifier(s): 48/34/0823, A40/34/0258