The EMA (Europe)
The EMA — the European Medicines Agency — assesses and monitors medicines for the entire European Union. Only after a positive opinion may a medicine be placed on the market in Europe. In the Netherlands, the CBG (College ter Beoordeling van Geneesmiddelen, the Dutch Medicines Evaluation Board) also provides oversight.
The FDA (United States)
The FDA — the American Food and Drug Administration — is the regulator in the US. Much GLP-1 medication has been assessed by both the FDA and the EMA, which means the medicine has been tested in two rigorous, independent systems.
What does “approved” mean?
Approval means a medicine has gone through an extensive assessment process before it may be prescribed. The regulator tests, among other things, the efficacy (does it do what it promises?), the quality of manufacturing and the safety (do the benefits outweigh the risks?). That assessment is based on clinical studies in large groups of patients. Even after authorisation, side effects are actively monitored, so that the balance between benefits and risks remains under continuous surveillance.
Approval applies per indication
Important to know: a medicine is approved for a specific use (indication). For example, Wegovy and Saxenda are registered for weight management, while Ozempic is registered for type 2 diabetes. When an approved medicine is used outside its registered indication, this is called off-label use. This is permitted in the Netherlands, but always takes place on an individual basis and under the responsibility of a doctor.
What does this mean at Go Leaner?
We work exclusively with registered GLP-1 medication that has been assessed by the EMA and/or FDA. Based on your blood tests and an in-person consultation, a BIG-registered doctor assesses whether a medicine is safe and suitable for your situation, and discusses whether any off-label use is appropriate. That is how we combine proven medication with personal medical supervision.
Frequently asked questions
What does FDA stand for?
FDA stands for the American Food and Drug Administration: the regulator in the United States that assesses and approves medicines, food and medical devices for efficacy and safety.
What does EMA stand for?
EMA stands for the European Medicines Agency. The EMA assesses medicines for the entire European Union. In the Netherlands, the CBG (College ter Beoordeling van Geneesmiddelen, the Dutch Medicines Evaluation Board) also provides oversight.
Are Ozempic, Wegovy and Mounjaro approved?
Yes, these medicines have been assessed and registered by the EMA and FDA. Approval applies per indication: some are registered for type 2 diabetes, others (such as Wegovy and Saxenda) specifically for weight management. Prescribing outside the registered indication is called off-label and is only done on an individual basis by a BIG-registered doctor.
What does approval mean for me?
It means the medicine has gone through a rigorous assessment process for efficacy, quality and safety, and that side effects are actively monitored after authorisation. It does not replace personal medical advice: a BIG-registered doctor always assesses whether a medicine is safe and suitable for your situation.
This page is for information purposes and does not replace medical advice. Always make medical decisions in consultation with a BIG-registered doctor.