NUCEIVA Powder for solution for injection Ref.[27531] Active ingredients: Botulinum toxin type A

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Evolus Pharma Ltd, 70 Sir John Rogersons Quay, Dublin 2, Ireland

Product name and form

NUCEIVA 50 Units powder for solution for injection.

NUCEIVA 100 Units powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection.

White powder.

Qualitative and quantitative composition

Each vial contains 50 Units botulinum toxin type A produced by Clostridium botulinum.

Each vial contains 100 Units botulinum toxin type A produced by Clostridium botulinum.

After reconstitution each 0.1 mL of the solution contains 4 Units.

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

Human albumin
Sodium chloride

Pack sizes and marketing

Vial (Type I glass) fitted with a stopper (chlorobutyl rubber) and a seal (aluminium).

Pack size of one.

Marketing authorization holder

Evolus Pharma Ltd, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland

Marketing authorization dates and numbers

EU/1/19/1364/001
EU/1/19/1364/002

Date of first authorisation: September 27, 2019

Drugs

Drug Countries
NUCEIVA Austria, Canada, Estonia, Croatia, Ireland, Italy, Lithuania, Poland

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