Irminix® 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. An approval from a regulatory authority 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. By May 2018 there have been over a hundred approvals and shippings to Switzerland, Germany, Austria, New Zealand, UK, Lebanon and the USA.
Irminix®: The Treatment
Currently, we can offer a 14-day treatment x 300mg per day of Irminix®. 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) to be treated, and the nature and severity of the disease of the individual patient.
No approval by the regulatory authority needed for the physician to order the drug:
- New Zealand – MedSafe allows the importation of Irminix® by authorized prescribers under Section 25 of the New Zealand Medicines Act 1981
- Lebanon – Ministry of Public Health has approved the import by physicians for individual patients.
- Switzerland – Article 49 of the 2018 Regulation for the Authorisation of Medicines permit an attending physician holding a cantonal licence to import small quantities of human medicine for Compassionate Use for the treatment of a given patient.
Approval by the regulatory authority not required under certain circumstances:
- Austria – The Austrian form must be an urgently needed for the treatment of specific patient to avert a life-threatening or chronically debilitating situation and that successful treatment with licensed or available medicinal products cannot be achieved based on the scientific state of the art.
- Germany – the physician can send us an email at [email protected] and we will explain how this is handled.
Approval from regulatory authority required in most countries:
- United Kingdom – A system has been set up through a company that handles the application process to the MHRA; the physician can send us an email at [email protected] and we will explain how this is handled.
- US – The FDA has a complicated two step process.
1) The physician will need to fill out all the necessary documents for the Irminix® Early Access program.
2) An Institutional Review Board (IRB) is required to oversee the actual treatment. There will be IRB information contained in the early access documents for the USA.
- Most other countries.
Discover The Future of Health
We are committed to improving health by way of our unique metal chelator and antioxidant, Irminix®