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Nuceiva
Published
Product name
Nuceiva
Active ingredient
PrabotulinumtoxinA
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Nuceiva (prabotulinumtoxinA)) was approved for the following therapeutic use:
Nuceiva is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients.
How this medicine works
Botulinum toxin type A (Clostridium botulinum neurotoxin) blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving synaptosomal-associated protein, 25kDa (SNAP-25), a protein integral to the docking and release of acetylcholine from vesicles situated within the nerve terminals.
After injection, there is an initial high-affinity binding of toxin to specific cell surface receptors on cholinergic nerve terminals. Bound toxin is then internalised by endocytosis, and the catalytic light chain is translocated across the vesicular membrane into the cytosol where it cleaves SNAP-25. Progressive inhibition of acetylcholine release follows and clinical signs usually manifest within 2 to 3 days.
Recovery after intramuscular injection takes place normally within 12 weeks.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Nuceiva was considered favourable for the therapeutic use approved.
Sponsor