Wegovy - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

semaglutide

Opinion

On 21 May 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Wegovy. The marketing authorisation holder for this medicinal product is Novo Nordisk A/S.

The CHMP adopted a new pharmaceutical form associated with a new route of administration, tablets for oral use, in four new strengths (1.5 mg, 4 mg, 9 mg and 25 mg).

The full indications for Wegovy tablets for oral use will be as follows:

Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of

• ≥ 30 kg/m² (obesity), or
• ≥ 27 kg/m² to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

For trial results with respect to populations studied, see section 5.1.

The indications for Wegovy solution for injection in pre-filled pens remain unchanged and are available in the summary of product characteristics (SmPC).

Detailed recommendations for the use of this product will be described in the updated SmPC, which will be published on EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

CHMP post-authorisation summary of positive opinion for Wegovy (X/0000296344)

Adopted Reference Number: EMADOC-1700519818-2790091

Key facts

• Name of medicine:
  Wegovy
• EMA product number:
  EMEA/H/C/005422
• Active substance:
  semaglutide
• International non-proprietary name (INN) or common name:
  semaglutide
• Therapeutic area (MeSH):
  • Obesity
  • Overweight
• Anatomical therapeutical chemical (ATC) code:
  A10BJ06
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Novo Nordisk A/S
• Date of opinion:
  21/05/2026
• Status:
  Positive