COPAXONE

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

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 more about Glatiramer

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
COPAXONE Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	10416F
BR	Câmara de Regulação do Mercado de Medicamentos	537500101151219, 537517120007103
CA	Health Products and Food Branch	02245619, 02456915
EE	Ravimiamet	1241244, 1346598, 1612279, 1612280, 1618196, 1671634, 1671645, 1859171
ES	Centro de información online de medicamentos de la AEMPS	65983, 79515
FI	Lääkealan turvallisuus- ja kehittämiskeskus	018779, 414592
FR	Base de données publique des médicaments	60082062, 67611486
GB	Medicines & Healthcare Products Regulatory Agency	298218, 82619
HR	Agencija za lijekove i medicinske proizvode	HR-H-157986508, HR-H-304476486
IE	Health Products Regulatory Authority	88575, 88580
IL	מִשְׂרַד הַבְּרִיאוּת	6121, 7477, 8579
IT	Agenzia del Farmaco	035418021, 035418060
JP	医薬品医療機器総合機構	3999440G1024
LT	Valstybinė vaistų kontrolės tarnyba	1004651, 1036975, 1070238, 1070239, 1070394, 1075312, 1075313, 1093374
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	380M2004
NL	Z-Index G-Standaard	14927535
NL	Z-Index G-Standaard, PRK	124346, 74284
NZ	Medicines and Medical Devices Safety Authority	11109, 17956, 21061
PL	Rejestru Produktów Leczniczych	100172867, 100333371
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W62547001, W62547002, W62547003
TR	İlaç ve Tıbbi Cihaz Kurumu	8699638950478, 8699638953967
US	FDA, National Drug Code	68546-317, 68546-325
ZA	Health Products Regulatory Authority	48/34/0823, A40/34/0258