BOTOX

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

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 more about Botulinum toxin type A

Medication package inserts

Below package inserts are available for further reading:

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