CHMP positive opinion for oral Wegovy tablets (semaglutide) – NovoNordisk
On 21 May 2026, the 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.
The indications for Wegovy solution for injection in pre-filled pens remain unchanged and are available in the summary of product characteristics (SmPC).
