ALLUZIENCE Solution for injection Ref.[50428] Active ingredients: Botulinum toxin type A

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

Product name and form

Alluzience, 200 Speywood units/mL, solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless solution.

Qualitative and quantitative composition

Clostridium botulinum toxin type A haemagglutinin complex 200 Speywood units/ml Botulinum toxin units are not interchangeable from one product to another.

Doses recommended in Speywood units are different from other botulinum toxin preparations.

Each vial contains 125 Speywood units in 0.625 ml of solution.

For the 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

L-histidine
Sucrose
Sodium chloride
Polysorbate 80
Hydrochloric acid for pH adjustment
Water for Injections

Pack sizes and marketing

Nature of container/closure: Type 1 glass vial, butyl rubber closure and aluminum overseal with a polypropylene flip-off top.

Contents of container: Each vial contains 125 Speywood units of Clostridium botulinum type A toxin-haemagglutinin complex in 0.625 ml of solution. Clear colourless solution.

Pack sizes:

Individual pack size: Pack containing 1 or 2 vials of Alluzience 200 Speywood units/ml solution for injection.

Multiple Pack: A multipack contains 6 individual packs, each including 2 vials of Alluzience 200 Speywood units/ml solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder

Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

Marketing authorization dates and numbers

PA1613/004/001

Date of first authorisation: 10th September 2021

Drugs

Drug Countries
ALLUZIENCE Estonia, Finland, Croatia, Ireland, Lithuania, Poland, Romania

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