Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Ipsen Limited, 190 Bath Road, Slough, SL1 3XE, United Kingdom
Azzalure, 125 Speywood units, powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection. The powder is white. |
Botulinum toxin type A* Quantity corresponding to 125 Speywood units (U)** for one vial.
* Clostridium botulinum toxin A haemagglutinin complex.
** The Speywood units of Azzalure are specific to the preparation and are not interchangeable with other preparations of botulinum toxin.
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 200 g/L |
125 Speywood units in a powder in a vial (Type I glass), with a stopper (halobutyl) and seal (aluminium).
Pack size of 1 or 2 vial(s).
Not all pack sizes may be marketed.
Ipsen Limited, 190 Bath Road, Slough, SL1 3XE, United Kingdom
PL 06958/0031
Date of first authorisation: 26 February 2009
Date of latest renewal: 28 January 2014
| Drug | Countries | |
|---|---|---|
| AZZALURE | Austria, Spain, Finland, France, Croatia, Ireland, Malta, Netherlands, Poland, United Kingdom |
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