Is Mysimba EMA approved, and how can you find it in Germany?

Last updated: 06 March 2025

Is Mysimba EMA approved, and how can you find it in Germany?

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Mysimba is a prescription medication that has sparked growing interest in recent years. Particularly among those struggling with obesity and looking for Ozempic alternatives.

Is Mysimba EMA approved, and what should patients in Germany know about the medicine? Let's take a closer look at how Mysimba works, its availability in Germany, and who can prescribe it.

What does Mysimba do?

Mysimba is a combination of two active substances: naltrexone and bupropion. Together, they target areas of the brain involved in controlling appetite and energy use.

When combined, the two active substances influence the central nervous system to help reduce food cravings and manage emotional eating behavior.

Mysimba is typically prescribed as part of a broader weight management plan that includes diet changes, increased physical activity, and behavioral support.

Mysimba is intended for adults with:

  • BMI (Body Mass Index) of 30 or higher (classified as obese), or
  • BMI of 27 or higher (overweight) if they also have weight-related health conditions like type 2 diabetes or high blood pressure 1.

Who is Mysimba not suitable for?

As with any medicine, Mysimba is not suitable for everyone. Patients who use opioids (such as morphine or codeine), are dependent on opioids, are taking treatments like methadone or buprenorphine, or are going through opioid withdrawal, should not be taking Mysimba.

This is because the naltrexone in Mysimba blocks the effects of opioids. This can lead to serious side effects like seizures and serotonin syndrome, and reduce the effectiveness of opioid painkillers during surgery 2.

Your doctor will best be able to determine if Mysimba is suitable to take along with other medicines you may be using.

Is Mysimba EMA approved?

Yes. The European Medicines Agency (EMA) first approved Mysimba in 2015 for use across the EU, including Germany. The approval was based on studies showing that Mysimba can help support moderate weight loss when combined with lifestyle changes.

Is Mysimba available in Germany?

For a few years, Mysimba was not available in Germany, despite being EMA-approved. However, as of 2025, it is now again possible to find Mysimba in online pharmacies in Germany.

Can you buy Mysimba without a prescription?

No. Mysimba requires a prescription from your doctor. He or she will evaluate if the medicine is relevant for your condition, as well as take into account any accompanying conditions or medicines you're taking.

Who can prescribe naltrexone bupropion?

You can get a prescription for naltrexone bupropion (Mysimba) from your family doctor, or the specialist who is treating you for your obesity. If you're unsure where to start, speaking to your family doctor first is a good option.

Already have a prescription for Mysimba?

Has your doctor advised treatment with Mysimba? You can get in touch with our expert Medicine Access team for help in finding the medicine in Germany. Along with our partner pharmacies, we will support you in starting your treatment as soon as possible.

 

 

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