BOTOX

This brand name is authorized in Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Botulinum toxin type A UNII E211KPY694 - BOTULINUM TOXIN TYPE A

Botulinum toxin type A is a protein complex derived from Clostridium botulinum. The protein consists of type A neurotoxin and several other proteins. Under physiological conditions it is presumed that the complex dissociates and releases the pure neurotoxin. Intramuscular injection of the neurotoxin complex blocks cholinergic transport at the neuromuscular junction by preventing the release of acetylcholine. The nerve endings of the neuromuscular junction no longer respond to nerve impulses and secretion of the chemotransmitter is prevented (chemical denervation). Read about Botulinum toxin type A

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
BOTOX Powder for 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
M03AX01	Botulinum toxin	M Musculo-skeletal system → M03 Muscle relaxants → M03A Muscle relaxants, peripherally acting agents → M03AX Other muscle relaxants, peripherally acting agents
Discover more medicines within M03AX01

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): 10993N, 10997T, 10998W, 10999X, 11000Y, 11004E, 11016T, 11023E, 11751L, 12017L
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 501001201158312, 501001202154418, 501012080012003
Country: CA	Health Products and Food Branch	Identifier(s): 01981501, 02243721
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 165-MBE-1020, 21.720-1-12-04
Country: EE	Ravimiamet	Identifier(s): 1009426, 1679867, 1679878, 1679889, 1679890, 1679902, 1679924, 1679935, 1679946, 1679957, 1679968, 1679979, 1679980, 1679991
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 63194, 70602, 72377
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 002853, 026491, 095092
Country: FR	Base de données publique des médicaments	Identifier(s): 62395974, 66330568, 67312950
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 102209, 134233, 165901
Country: HK	Department of Health Drug Office	Identifier(s): 41906, 60427
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-209629111, HR-H-744022704
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6719, 7037, 7255
Country: JP	医薬品医療機器総合機構	Identifier(s): 1229404D1020, 1229404D2026, 122940AD1026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1075795, 1075796, 1075797, 1078540, 1078541, 1078542, 1078543, 1078544, 1078545, 1078546, 1078547, 1078548, 1078549, 1078550, 1082462
Country: MT	Medicines Authority	Identifier(s): MA1304/00401, MA1304/00402, MA1304/00403
Country: NL	Z-Index G-Standaard	Identifier(s): 13879065, 15633462
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 40436, 95737
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 14502, 15318, 6332
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100201669, 100267846
Country: SG	Health Sciences Authority	Identifier(s): 08205P, 14202P, 14203P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 3983041H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699490550618, 8699490550625, 8699490579015
Country: US	FDA, National Drug Code	Identifier(s): 0023-1145, 0023-3919, 0023-3921, 0023-9232
Country: ZA	Health Products Regulatory Authority	Identifier(s): 27/30.4/0164