EU Botulinum Toxin Regulatory Status
此内容尚不支持你的语言。
Botulinum toxin regulatory status in the European Union depends on the exact product, authorisation route, and territory. A centralised authorisation is valid throughout the EU; a national authorisation establishes approval in the country that grants it, including when several countries coordinate their assessment. Under the centralised route, the European Medicines Agency (EMA) evaluates the medicine and the European Commission grants the authorisation (EU authorisation routes — European Commission 🔗).
Nuceiva and Boey have EU-wide centralised authorisations. The national product records below establish authorisation in Spain, an EU member state; they do not establish identical authorisations or indications across all 27 EU countries. The EU indication matrix separates aesthetic and therapeutic uses using the corresponding approved product information.
Centrally Authorised Products
Section titled “Centrally Authorised Products”A marketing authorisation holder is the legal entity named in the authorisation. That role should not be substituted for the physical manufacturer, product developer, or commercial partner.
| Product | EU authorisation | Marketing authorisation holder | Approved scope and official evidence |
|---|---|---|---|
| Nuceiva | Centralised; September 27, 2019. | Evolus Pharma B.V. | Type A toxin; temporary improvement of moderate to severe glabellar lines in adults younger than 65 when the lines have an important psychological impact. Nuceiva — EMA 🔗; EMA Nuceiva product information 🔗. |
| Boey | Centralised; July 15, 2026. | AbbVie Limited | TrenibotulinumtoxinE, a type E toxin; temporary improvement of moderate to severe glabellar lines at maximum frown in adults when the lines have an important psychological impact. Intended for occasional use. Boey — EMA 🔗; EMA Boey product information 🔗. |
Nuceiva’s regional product relationship is covered under Jeuveau / Nabota and Evolus. Boey is a separate type E product, rather than an additional Botox type A presentation. Neither EU authorisation establishes FDA approval or an additional indication in the United States; U.S. regulatory status is a separate record.
Nationally Authorised Products: Spain
Section titled “Nationally Authorised Products: Spain”Spain’s medicines regulator, the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), publishes national medicine records and approved product information through CIMA. These nine type A product records provide a national counterpart to the centralised approvals above. The authorisation numbers identify the particular presentations linked below; they are not a list of every strength, pack, or authorisation held by the product family.
| Product / referenced presentation | Spanish authorisation number | Holder named in the Spanish record | Official Spanish product information |
|---|---|---|---|
| Botox, 100 Allergan units | 63194 — CIMA record 🔗 | AbbVie Spain, S.L.U. | AEMPS Botox SmPC 🔗 |
| Vistabel, 4 Allergan units / 0.1 mL | 65837 — CIMA record 🔗 | AbbVie Spain, S.L.U. | AEMPS Vistabel SmPC 🔗 |
| Dysport, 500 units | 61155 — CIMA record 🔗 | Ipsen Pharma, S.A.U. | AEMPS Dysport SmPC 🔗 |
| Azzalure, 125 Speywood units | 71300 — CIMA record 🔗 | Ipsen Pharma, S.A.U. | AEMPS Azzalure SmPC 🔗 |
| Alluzience, 200 Speywood units / mL | 86170 — CIMA record 🔗 | Ipsen Pharma | AEMPS Alluzience SmPC 🔗 |
| Xeomin, 50 units | 74067 — CIMA record 🔗 | Merz Pharmaceuticals GmbH | AEMPS Xeomin SmPC 🔗 |
| Bocouture, 50 units | 72709 — CIMA record 🔗 | Merz Pharmaceuticals GmbH | AEMPS Bocouture SmPC 🔗 |
| Letybo, 50 units | 87951 — CIMA record 🔗 | Croma-Pharma GmbH | AEMPS Letybo SmPC 🔗 |
| Relfydess, 100 units / mL | 89758 — CIMA record 🔗 | Ipsen Pharma | AEMPS Relfydess SmPC 🔗 |
Botox and Vistabel, Dysport and Azzalure, and Xeomin and Bocouture have separate named Spanish product records. The indication attached to one record should not be transferred to the other on the basis of a related product family. Alluzience and Relfydess likewise retain their own product information. Their indications, age limits, and therapeutic or aesthetic scope appear separately in the EU indication matrix.
The Spanish Relfydess SmPC names Ipsen Pharma as the marketing authorisation holder. That is a local regulatory role; it does not redefine the product-development relationship covered in the Relfydess brand entry. Likewise, a national holder entry does not by itself identify the physical manufacturing site.
National authorisations can also exist in other EU countries. Absence from this selection means that a country or product is not represented here, rather than that it is unapproved. The UK and Switzerland are outside the geographic scope; EEA coverage in a source should not be silently relabelled as EU coverage.
NeuroBloc: Withdrawn EU Authorisation
Section titled “NeuroBloc: Withdrawn EU Authorisation”NeuroBloc, a type B toxin, received EU authorisation on January 22, 2001 for adult cervical dystonia. The European Commission withdrew that authorisation on December 9, 2022, at the request of the holder, Sloan Pharma S.a.r.l., following its decision to discontinue marketing for commercial reasons. EMA states that the authorisation is no longer valid (NeuroBloc withdrawal — EMA 🔗).
The historical approval and remaining EMA documents therefore do not establish a current EU authorisation. The commercial withdrawal should not be recast as a comparative finding about the safety or efficacy of other toxin products.
Who Grants Approval?
Section titled “Who Grants Approval?”| Route | Assessment and authorisation | Geographic scope |
|---|---|---|
| Centralised | EMA evaluates the application; the European Commission grants authorisation. | One authorisation valid throughout the EU. |
| Decentralised | Participating countries assess an application together, led by a reference member state; national authorities grant authorisations. | Countries granting authorisation through the procedure. |
| Mutual recognition | Participating countries recognise an existing national authorisation. | Countries granting authorisation through the procedure. |
| National | A national authority assesses and authorises the medicine for its own country. | The individual country. |
The European Commission’s authorisation framework 🔗 and national-procedure guidance 🔗 distinguish these routes. A coordinated procedure does not turn the resulting national authorisations into one centralised authorisation. A Spanish product record establishes the national authorisation cited above without requiring an assumption about every other participating country.
A positive EMA scientific opinion and a European Commission authorisation are separate milestones. Marketing authorisation also differs from local availability: pricing and reimbursement decisions take place at national or regional level (Authorisation of medicines — EMA 🔗).
Where To Check Approved Uses
Section titled “Where To Check Approved Uses”An absent EMA medicine page does not establish that a product is unapproved in the EU. EMA’s website covers medicines it evaluates; national registers complement that coverage (National registers of authorised medicines — EMA 🔗).
For a centrally authorised medicine, the EMA record and linked approved product information establish the authorisation and its scope. For a nationally authorised medicine, the relevant country’s register establishes the national record. The Summary of Product Characteristics (SmPC) defines the approved indications, patient limits, warnings, and other conditions of use for the exact product. In Spain, it is labelled ficha técnica.
The EU indication matrix compares those product-specific uses. The brand directory supplies broader product and company context; neither a global brand name nor another market’s label replaces the applicable EU or national record.