1. Moderate-to-severe chemotherapy-induced neuropathic pain
2. Post-burn pain
3. Post-burn itch
4. Chronic pain
An Early Access program for Halneuron may be opened if WEX determines that all of the following criteria are met:
• The disease or condition is seriously debilitating or serious.
• The investigational drug is the subject of an active clinical development program and is not approved in any indication in the country concerned
• The patient is not eligible to participate in a suitable clinical trial
• An adequate supply of the investigational drug exists to perform necessary clinical studies as well as to provide Early Access to patients who do not have alternative treatment options
• There is adequate available data to permit selection of an appropriate dose level
• Early Access does not impede or compromise the clinical development or regulatory approval of the drug under investigation
• There are sufficient clinical data available with respect to both the investigational drug and the disease condition for which the application is being sought, to anticipate that any potential benefits from treatment are likely to outweigh any potential risks to the patient
• The patient, treating physician, regulatory authority and the company agree to the use of Halneuron
• Supplied drug is used as clinically indicated from the product information supplied by Halneuron and in discussion with the treating physician
DISCLAIMER: An existing program does not guarantee availability in all countries. Various regulatory mechanisms exist in different countries to provide Early Access to new medicines and as a result, country specific variations for Early Access will occur. Any Early Access to medicines must always comply with the applicable country-specific laws and regulations including medicines importation requirements.