Ablymico
Authorised
This medicine is authorised for use in the European Union
liraglutide
MedicineHumanAuthorised
Maltese is available via eTranslation, the European Commission's machine translation service.
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Ablymico is a medicine used along with diet and increased physical activity to help manage weight in:
- adults with obesity (BMI of 30 or more);
- adults with overweight (BMI between 27 and 30) and weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep);
- adolescents from 12 years of age with obesity (BMI of 30 or more for adults according to international age- and gender-related cut-off points) who weigh more than 60 kg;
- children from 6 to less than 12 years of age with obesity (BMI at or above the 95th percentile) who weigh at least 45 kg.
BMI (body mass index) is a measure of a person’s weight in relation to their height. A BMI at the 95th percentile means that it is higher than that of 95% of people of the same age and gender.
Ablymico contains the active substance liraglutide and is a hybrid medicine. This means that it is similar to a reference medicine that contains the same active substance. The reference medicine for Ablymico is Saxenda.
Ablymico differs from Saxenda in the way the active substance is made. In Saxenda, the active substance is manufactured using living cells, whereas in Ablymico it is made using chemical processes.
Ablymico can only be obtained with a prescription. In children from 6 to less than 12 years of age, treatment with Ablymico should be started by a doctor experienced in the treatment of children with obesity.
Ablymico is given as an injection under the skin once daily using a pre-filled pen, in the thigh, upper arm or belly. The dose is slowly increased over 4 weeks. Treatment with Ablymico should be stopped if patients have not lost at least 4% (for adolescents and children from 6 years of age) or 5% (for adults) of their initial body weight after 12 weeks of treatment at the maximum dose or the maximum tolerated dose. The doctor should reassess the need to continue treatment once a year.
For more information about using Ablymico, see the package leaflet or contact your doctor or pharmacist.
The active substance in Ablymico, liraglutide, is a glucagon-like peptide-1 (GLP-1) receptor agonist. It acts in the same way as GLP-1, a natural hormone that regulates appetite. By attaching to receptors (targets) for GLP-1 in brain cells, liraglutide causes, among other effects, a feeling of fullness and reduces hunger and food cravings. This helps a person to reduce their food intake.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Saxenda, and do not need to be repeated for Ablymico.
As for every medicine, the company provided studies on the quality of Ablymico. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Studies carried out with Ablymico are described in more detail in the medicine’s assessment report.
For the full list of side effects and restrictions with Ablymico, see the package leaflet.
The most common side effects with Ablymico (which may affect more than 1 in 10 people) include nausea (feeling sick), vomiting, diarrhoea and constipation.
The European Medicines Agency concluded that, in accordance with EU requirements, Ablymico has been shown to have comparable quality and to be bioequivalent to Saxenda. Therefore, the Agency’s view was that, as for Saxenda, the benefits of Ablymico outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ablymico have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Ablymico are continuously monitored. Suspected side effects reported with Ablymico are carefully evaluated and any necessary action is taken to protect patients.
Ablymico received a marketing authorisation valid throughout the EU on 15 July 2026.
For information about the availability of this medicine in your country, contact your national competent authority.
Product information
15/07/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ablymico
- Active substance
- liraglutide
- International non-proprietary name (INN) or common name
- liraglutide
- Therapeutic area (MeSH)
- Obesity
- Overweight
- Anatomical therapeutic chemical (ATC) code
- A10BJ02
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Treatment of weight management.
News on Ablymico
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