Off-Label Prescribing

What is a medicine license?

When a drug is developed by any pharmaceutical company, it goes through a rigorous testing process to ensure it is safe. This process involves numerous clinical trials, which monitor the performance of the medicine in treating one or more specific conditions. The trials assess a number of criteria, including how well the treatment works, and whether or not it causes side effects.

At the end of this testing process, if the medicine produces successful results, it may be granted a license by the Medicines and Healthcare Products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) to treat the condition it has been tested for.

The license will specify certain information regarding the medication, including:

  • who can use it
  • storage and usage instructions
  • side effects and contraindications
  • and what conditions it may be used to treat

This can all be found in the patient information leaflet provided with the medicine.

What is “off-label” use?

Occasionally, you may be prescribed a licensed drug to treat a condition which it not listed in the product license. This is known as off-label prescribing.

A doctor/dentist/nurse prescriber etc will only prescribe off-label if they believe that the medication will be effective at treating the condition in question, and that the advantages outweigh any potential risks.

However, the prescriber needs to let you know beforehand that the drug is being prescribed off-label. They should also tell you about any potential risks associated with this method of use.

Your safety is our priority. We will always inform you when a medicine is being prescribed for an off-label use, and provide access to safety information regarding the medication.

If you have any further questions regarding the above or want further clarification, please feel free to contact us at

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NB: All treatment options are subject to the completion and assessment of a medical consultation form

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