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Early Access Programs

Understand Early Access to Pre-Approval Medicines

Learn about how Early Access Programs work and whether they could provide you with a suitable treatment option. For eligible patients, an Early Access Program is a way of receiving treatment with a pre-approval medicine.

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About Early Access Programs

An Early Access Program might be able to provide you with a suitable treatment option if you are a patient in high medical need who cannot participate in a Clinical Trial and you have exhausted all registered treatments.

In many countries, based on specific laws and regulations, your physician may be able to request access to pre-approval medicines to treat your condition.

Many terms are used to describe programs that provide access to pre-approval medicines:

  • Early Access Program
  • Expanded Access Program
  • Named Patient
  • Named Patient Import
  • Named Patient Program
  • Investigational Drug
  • Managed Access Program
  • Patient Specific Drug Import
  • Compassionate Use

Do you meet the criteria for Early Access?


 

If the pharmaceutical company developing the medicine is willing to provide pre-approval access to their medicine, and

If:

  • You have a life threatening or debilitating disease
  • You have no remaining viable treatment options with registered medicines or Clinical Trials
  • The authorities approve access to the pre-approval medicine

If your physician:

  • Is willing to prescribe the pre-approval medicine to you

If the medicine:

  • Has an indication of safety, tolerability, and efficacy

Then:

  • Early Access may be possible.
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Clinical Trials & Early Access Programs
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