Early Access Program

The use of drugs under development can be approved by a regulatory authority on a Individual Patient Use basis. This is also called Expanded Access, Named Patient Use, Compassionate Use, or Specials, depending on the country. The approval is based on whether the condition to be treated is serious enough, whether efficient and safe treatments are existing or lacking, and whether the drug has shown relevant efficacy and safety. In general, only a licensed physician can apply to the regulatory authority. In some countries, no approval is needed. To date there have been approvals and shippings to Switzerland, Germany, Austria, New Zealand, UK and the USA.

Application Information

To apply for an Individual Patient treatment, please follow the instructions of the following document Early-Access-Application (.rtf format can be opened in word; also available as PDF here or email us for a word version at earlyaccess@emeramed.com).

Currently, we can offer a 14-day treatment x 300mg per day. The treatment length and dosing are limited by the clinical studies that have been performed. If this is enough for the individual patient or not, we cannot answer, as it depends on the indication (disease) and the nature and severity of the disease in the individual patient.

Selected Country Information

No Approval Required – The following countries do not require for regulatory approval for a physician to use an unapproved medicine:

New Zealand

Approval Not Required In Some Cases:

Austria

       Germany

Approval Required – The following countries require regulatory approval for a physician to use an unapproved medicine:

Various EU Countries

Sweden

Denmark

United Kingdom

Various Non-EU Countries

Australia

Canada

US

        Most other countries.