REG-EMA-Wegovy-SmPC-2026 — Current EU Summary of Product Characteristics

[DRAFT — authored 2026-04-20. EMA SmPC reference URL verified 2026-04-20. Specific SmPC version/date requires confirmation at MD review.]

Source

European Medicines Agency. Wegovy (semaglutide) — Summary of Product Characteristics (SmPC). Centrally authorised medicine, Novo Nordisk.

External URL: EMA Wegovy EPAR page

EU Authorization Status (as of April 2026)

Wegovy holds centralized EU marketing authorization covering all EU/EEA member states. Current indications per SmPC:

1. Chronic weight management

Adjunct to reduced-calorie diet and increased physical activity for weight management in adults with:

Initial BMI ≥30 kg/m² (obesity), OR
Initial BMI ≥27 to <30 kg/m² (overweight) + at least one weight-related comorbidity (dysglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)

2. Cardiovascular risk reduction

Adults with established cardiovascular disease + overweight or obesity (BMI ≥27) — for reduction of MACE. Approved following EMA evaluation of the SELECT trial.

3. Higher-dose 7.2 mg

CHMP issued a positive opinion on December 12, 2025 for Wegovy 7.2 mg. European Commission final authorization decision expected early 2026. Cross-reference: REG-EMA-Wegovy-7-2mg-CHMP-Opinion-2025 – CHMP Positive Opinion.

4. Adolescent (≥12 years)

Chronic weight management in adolescents with obesity (BMI ≥95th percentile) — authorized at EU level.

Key EU Label Divergences from FDA Label

NAION warning — EMA YES, FDA NO (as of April 2026)

Per PRAC recommendation June 2-5, 2025, the EMA updated SmPC to include NAION (non-arteritic anterior ischemic optic neuropathy) as a very rare side effect:

Classification: "very rare" (may affect up to 1 in 10,000 patients)
Advice: patients experiencing sudden vision loss or rapidly worsening eyesight should contact their doctor without delay
Discontinuation: stop semaglutide if NAION occurs
Cross-reference: REG-EMA-PRAC-Semaglutide-NAION-2025 – EMA NAION Very Rare

FDA label has NOT been updated to include NAION warning as of April 2026 — a material regulatory divergence.

Suicidal ideation

EMA and FDA both removed suicidal-ideation warning language from GLP-1 RA labels (2024-2025) following null-finding reviews. Cross-reference: REG-FDA-Suicidal-Ideation-Review-2024 – FDA GLP1 Suicidal Ideation Null Finding.

Contraindications, Warnings (Shared with FDA Label)

Known hypersensitivity to semaglutide
Pregnancy and breastfeeding (not recommended)
Pancreatitis (caution / discontinue if suspected)
Thyroid C-cell tumor concern based on rodent data (reflected differently in EU vs US wording, but present in both)

Clinical Relevance

The EU SmPC is the authoritative label for European prescribing and bracket the regulatory landscape for multinational obesity-medicine practices. Teaching implications:

EU vs US NAION divergence is material — patients traveling internationally or provider-shopping internationally may see different warnings. Counsel accordingly.
7.2 mg EU approval lags US by ~3 months — CHMP positive opinion December 12, 2025; EC decision early 2026. FDA approved March 19, 2026 (NPV pathway). Nearly parallel timelines.
MACE indication was also approved by EMA following SELECT; minor timing and wording differences vs FDA.

Linked Peptides

Semaglutide

Related Regulatory Notes

REG-FDA-Wegovy-Label-2025-2026 – Current FDA Prescribing Information — US counterpart
REG-EMA-Wegovy-7-2mg-CHMP-Opinion-2025 – CHMP Positive Opinion — 7.2 mg CHMP opinion
REG-EMA-PRAC-Semaglutide-NAION-2025 – EMA NAION Very Rare — NAION classification

REG-EMA-Wegovy-SmPC-2026 – EU Summary of Product Characteristics