Mino-Lok Expanded Access - CitiusPharma2018

Mino-Lok® Expanded Access 

In the wake of the COVID 19 pandemic, the focus of our nation has been on control and treatment .  Due to the number of hospitalizations there is overwhelming increased need for central lines coupled with limited resources to remove and replace an infected CVC. It is believed that the need to salvage lines is even greater.

We are focusing on the health of the broader patient population that may be able to benefit from Mino-Lok. Therefore LMB/Citius has created an Expanded Access Program for Mino-Lok. Making this important investigational drug available for compassionate use is one way we, as a company, can offer support during this unprecedented time.

Expanded Access is a pathway for a patient with an immediately life-threatening condition, serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

The Expanded Access Program

To qualify for the Expanded Access program, the patient must be met the following criteria:

  • The patient must have a serious or immediately life-threatening disease or condition
  • Have no comparable or satisfactory alternative therapy, including ongoing clinical trials
  • The potential benefit outweighs the potential risks of the treatment
  • Providing access to the investigational therapy must not interfere with the completion of a clinical trial supportive of a Health Authority approval or compromise the potential development of the therapy
  • The patient does not qualify for the clinical study

For the safety and privacy of our patients, we can only accept requests from a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational therapy, monitoring, managing and reporting side effects. If you are a patient with a long term central venous catheter please ask your physician about this therapy. Should you be interested in requesting further information about our expanded access program please feel free to contact us at expandedaccess@citiuspharma.com.