Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Evolus Pharma Ltd, 70 Sir John Rogersons Quay, Dublin 2, Ireland
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. |
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 |
Vial (Type I glass) fitted with a stopper (chlorobutyl rubber) and a seal (aluminium).
Pack size of one.
Evolus Pharma Ltd, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland
EU/1/19/1364/001
EU/1/19/1364/002
Date of first authorisation: September 27, 2019
| Drug | Countries | |
|---|---|---|
| NUCEIVA | Austria, Canada, Estonia, Croatia, Ireland, Italy, Lithuania, Poland |
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