BOTOX Powder for solution for injection

Active ingredients: Botulinum toxin type A

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.

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

Allergan Limited, Marlow International, The Parkway, Marlow, Bucks SL7 1YL, UK

Marketing authorization dates and numbers

PL 00426/0074

17 May 1994

Drugs

Drug
Countries
BOTOX
Austria, Australia, Brazil, Canada, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom, United States
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