BOTOX Powder for solution for injection Ref.[6581] Active ingredients: Botulinum toxin type A

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK

Product name and form

BOTOX 100 Allergan Units.

Powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection.

BOTOX product appears as a thin white deposit that may be difficult to see on the base of the vial.

Qualitative and quantitative composition

Botulinum toxin* type A, 100 Allergan Units/vial.

* from Clostridium botulinum

Botulinum toxin units are not interchangeable from one product to another.

For a full list of excipients, see section 6.1.

Active Ingredient Description
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).

List of Excipients

Human albumin
Sodium chloride

Pack sizes and marketing

Clear glass vial, with rubber stopper and tamper-proof aluminium seal, containing white powder for solution for injection.

Pack size:

  • Carton comprising one 100 Allergan Unit vial and package leaflet.
  • Packs containing one, two, three or six cartons.

Not all pack sizes may be marketed.

Marketing authorization holder

AbbVie Ltd., Maidenhead, SL6 4UB, UK

Marketing authorization dates and numbers

PL 41042/0057

17 May 1994

Drugs

Drug Countries
BOTOX Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.