EU Botulinum Toxin Indication Matrix
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Botulinum toxin indications in the European Union depend on the exact product and the territory covered by its authorisation. A centralised authorisation provides EU-wide product information; national authorisations require the applicable country’s label. An indication confirmed in Spain does not, by itself, establish the same approved use in every EU member state (EU authorisation procedures — European Commission 🔗).
The scope below is the EU’s 27 member states, using centralised EU product information for Nuceiva and Boey and national Spanish labels for other represented products. Spain is a defined national reference, not a substitute for a 27-country register. UK, Swiss, and other non-EU labels are outside this comparison.
The Summary of Product Characteristics (SmPC) is the professional product information defining approved indications and conditions of use. The indication wording is in section 4.1; age restrictions and other conditions may also appear in section 4.2. The EU regulatory status document distinguishes authorisation routes, product records, and withdrawn authorisations.
Aesthetic Indication Matrix
Section titled “Aesthetic Indication Matrix”All aesthetic uses below concern temporary improvement of moderate to severe lines with an important psychological impact. Glabellar lines are assessed at maximum frown, lateral canthal lines / crow’s feet at maximum smile, and forehead lines at maximum contraction or eyebrow elevation, according to the product’s wording. Each row retains its own age and territorial limits in the linked SmPC.
| Product / territory | Approved aesthetic areas | Population limits | Official product information |
|---|---|---|---|
| Vistabel — Spain; Botox brand context | Glabellar lines; lateral canthal lines; forehead lines, individually and/or in the combinations described in the SmPC. | Adults. Section 4.1 does not impose an under-65 cutoff; section 4.2 notes limited phase III data in patients older than 65. | Vistabel SmPC — AEMPS/CIMA 🔗 |
| Azzalure — Spain | Glabellar lines and/or lateral canthal lines. | Adults younger than 65. | Azzalure SmPC — AEMPS/CIMA 🔗 |
| Alluzience — Spain | Glabellar lines. | Adults younger than 65. | Alluzience SmPC — AEMPS/CIMA 🔗 |
| Bocouture — Spain | Upper facial lines: glabellar lines and/or lateral periorbital lines and/or horizontal forehead lines. | Adults younger than 65. | Bocouture SmPC — AEMPS/CIMA 🔗 |
| Nuceiva — centralised EU authorisation; Jeuveau / Nabota brand context | Glabellar lines. | Adults younger than 65. | Nuceiva EU product information — EMA 🔗 |
| Letybo — Spain | Glabellar lines. | Adults younger than 75, rather than the under-65 limit used by several other products. | Letybo SmPC — AEMPS/CIMA 🔗 |
| Relfydess — Spain | Glabellar lines and lateral canthal lines, alone or in combination. | Adults younger than 65. | Relfydess SmPC — AEMPS/CIMA 🔗 |
| Boey — centralised EU authorisation | Glabellar lines. | Adults; section 4.1 does not impose an under-65 cutoff. The SmPC specifies occasional use. | Boey EU product information — EMA 🔗 |
An area absent from a row is not named as an indication in that row’s cited SmPC. That is different from an unverified product-country combination, and does not establish the product’s status in another EU country. Neither clinical studies nor use in practice add an indication to a product’s authorisation.
Facial Areas and Age Limits Are Separate Claims
Section titled “Facial Areas and Age Limits Are Separate Claims”Azzalure and Alluzience illustrate why the exact product name matters: the Spanish Azzalure label includes lateral canthal lines, while the Spanish Alluzience label specifies glabellar lines. A shared broad toxin category does not transfer one product’s approved areas to another.
The age boundary also needs its own check. The Spanish Letybo indication includes adults below 75, while Nuceiva’s centralised EU indication specifies adults below 65. Vistabel and Boey specify adults without that under-65 cutoff in section 4.1. These distinctions concern label scope, not comparative clinical suitability.
Therapeutic Indication Matrix
Section titled “Therapeutic Indication Matrix”The following rows use Spanish national product information. They preserve differences in the cause of a condition, affected anatomy, prior-treatment requirements, and pediatric populations. A general term such as “spasticity” or “bladder dysfunction” does not capture the full authorised indication.
| Product / territory | Therapeutic indications | Key population and indication limits | Official product information |
|---|---|---|---|
| Botox — Spain | Focal spasticity; blepharospasm, hemifacial spasm, and associated focal dystonias; cervical dystonia; chronic migraine; idiopathic overactive bladder; urinary incontinence from neurogenic detrusor overactivity; severe persistent primary axillary hyperhidrosis. | Pediatric cerebral palsy: ambulant patients aged 2 or older, ankle/foot spasticity, as an adjunct to rehabilitation. Adult post-stroke spasticity: wrist/hand and ankle/foot. Migraine: adults with at least 15 headache days/month, including at least 8 migraine days, and inadequate response or intolerance to preventive medicines. Overactive bladder: adults with inadequate response or intolerance to anticholinergics. Neurogenic urinary incontinence: adults with stable subcervical spinal cord injury or multiple sclerosis. Axillary hyperhidrosis must interfere with daily activities and resist topical treatment. Other age and use restrictions remain indication-specific. | Botox SmPC — AEMPS/CIMA 🔗, sections 4.1–4.2 |
| Dysport — Spain | Adult post-stroke upper- and lower-limb focal spasticity; spasmodic torticollis; hemifacial spasm; blepharospasm; urinary incontinence from neurogenic detrusor overactivity; pediatric cerebral-palsy spasticity. | Bladder indication: adults with spinal cord injury or multiple sclerosis who regularly perform clean intermittent catheterisation. Pediatric cerebral palsy: age 2 or older for upper-limb spasticity and for spasticity associated with dynamic equinus foot deformity; the equinus indication specifies children who are not bedridden. | Dysport SmPC — AEMPS/CIMA 🔗, sections 4.1–4.2 |
| Xeomin — Spain | Adult blepharospasm and hemifacial spasm; predominantly rotational cervical dystonia; adult upper-limb spasticity; chronic sialorrhea; pediatric spasticity associated with equinus foot in cerebral palsy. | Adult sialorrhea: due to neurological disorders. Pediatric sialorrhea: ages 2–17 and weight at least 12 kg, due to neurological/neurodevelopmental disorders. Cerebral-palsy equinus spasticity: ages 2–17, including ambulant and non-ambulant patients. The September 2026 SmPC includes this pediatric equinus indication; pediatric upper-limb spasticity is not named in section 4.1. | Xeomin SmPC — AEMPS/CIMA 🔗, sections 4.1–4.2 |
The tables summarise approved uses; the linked SmPCs retain the complete contraindications, warnings, administration conditions, and indication-specific restrictions. Pediatric clinical data elsewhere in an SmPC do not automatically establish a pediatric indication in section 4.1.
Product Names and Comparison Limits
Section titled “Product Names and Comparison Limits”Vistabel and Botox have separate Spanish label entries, as do Bocouture and Xeomin. Their indications should remain tied to the exact named product rather than being combined under a familiar international brand family. The U.S. FDA indication matrix is a separate jurisdictional comparison; U.S. labels do not establish EU indications.
Boey’s EU product information identifies trenibotulinumtoxinE, a type E toxin. Nuceiva’s identifies a type A toxin. Their shared glabellar-line indication does not make the products the same toxin type, and neither label permits units to be transferred between products. The other linked SmPCs likewise retain product-specific unit language. Unit interpretation explains why a shared indication cannot establish a unit conversion.
Authorisation also differs from actual local supply or reimbursement. For a country outside the Spanish examples, the relevant national register and applicable SmPC remain necessary; EMA’s national-register directory 🔗 provides the official starting points. The centralised-versus-national distinction and approval-versus-availability distinction are described in EMA’s authorisation guidance 🔗.