Description
Bocouture 50iu (Single Vial) is a prescription-only injectable medicine containing 50 units of botulinum toxin type A. It is supplied as a white powder for solution for injection and is intended for intramuscular administration by appropriately qualified healthcare professionals.
Bocouture is indicated for the temporary improvement of moderate to severe glabellar frown lines, lateral periorbital lines (crow’s feet), and horizontal forehead lines in adults below 65 where the severity of the lines has an important psychological impact. Bocouture units are product-specific and should not be treated as interchangeable with units of other botulinum toxin preparations.
Treatment Areas / Indications
The current UK SmPC lists the following aesthetic indications:
- Glabellar frown lines — moderate to severe vertical lines between the eyebrows at maximum frown.
- Lateral periorbital lines — moderate to severe lines around the outer eye area at maximum smile, commonly known as crow’s feet.
- Horizontal forehead lines — moderate to severe lines visible at maximum forehead contraction.
The authorised indication applies to adults below 65 years of age where the severity of the lines has an important psychological impact for the patient.
Usage / Administration (IFU / SmPC-Only)
Bocouture should only be administered by an appropriately qualified healthcare practitioner with expertise in the relevant indication and use of the required equipment, in accordance with national guidelines.
General Administration
- Route: Intramuscular injection after reconstitution.
- Injection needle: Thin sterile needle, e.g. 30–33 gauge, 0.20–0.30 mm diameter and 13 mm length.
- Injection volume: Approximately 0.04–0.1 mL per injection site.
- Treatment interval: Treatments should not be administered more frequently than every 3 months.
Ingredient List
Active ingredient:
- Botulinum toxin type A (150 kD)
- 50 units per vial
- Purified from Clostridium botulinum
- Free from complexing proteins
Presentation & Longevity
Presentation
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- 1 × 50-unit vial
- White powder for solution for injection
Shelf Life & Storage
The unopened product has a stated shelf life of 3 years and should not be stored above 25°C.
After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2–8°C. From a microbiological perspective, the SmPC states that the product should be used immediately unless reconstitution has occurred under controlled and validated aseptic conditions.
Duration
For the authorised upper facial indications, the SmPC states that the effect lasts up to four months.
Regulatory Status
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- Prescription Only Medicine (POM)
- Active ingredient: botulinum toxin type A
- Pharmaceutical form: powder for solution for injection
- UK Marketing Authorisation: PL 29978/0002
- Marketing Authorisation Holder: Merz Pharmaceuticals GmbH
- UK company: Merz Aesthetics UK Ltd
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Bocouture is regulated as a medicinal product rather than a CE/UKCA-marked medical device. The current UK SmPC was revised on 19 January 2026.
FAQ
1. What is Bocouture 50 units used for?
Bocouture 50 units is indicated for the temporary improvement of moderate to severe upper facial lines in eligible adults below 65 years. The current UK SmPC covers glabellar frown lines, lateral periorbital lines and horizontal forehead lines when the severity has an important psychological impact. Botulinum toxin type A temporarily reduces targeted muscle activity by inhibiting acetylcholine release at the neuromuscular junction.
2. Is Bocouture 50 units the same as Botox or Azzalure?
Bocouture, BOTOX and Azzalure are botulinum toxin type A medicines, but they are separate products with product-specific formulations, potency assays and prescribing instructions. The Bocouture SmPC specifically states that its unit doses are not interchangeable with those of other botulinum toxin type A preparations. Therefore, Bocouture 50 units should not be converted or substituted on a simple unit-for-unit basis with another product without reference to its own prescribing information.
