Named Patient Supplies

Named Patient Supplies enable healthcare professionals, on behalf of their patients, to access medicines approved or nearing approval in other countries before marketing authorisation has been granted in their home country.

The treating healthcare professional makes the clinical judgment that no comparable or satisfactory alternative approved therapy is currently available for a given patient and that the probable risks from the investigational drug are not greater than the probable risks from the condition itself.

In the UK, provision for granting access to investigational drugs for patients is governed by The Medicines and Healthcare Regulatory Agency (MHRA), who are responsible for ensuring the safe supply of medicines to patients. The MHRA may provide licenses to companies who demonstrate the capabilities and facilities to manage the provision of unlicensed medicines in accordance with MHRA guidelines. In the US, the Food and Drug Administration (FDA) governs the equivalent process.

Often grouped under the labels of compassionate use, special access, expanded access, or named patient supply, these provisions allow companies to provide patients with access to their medicines while the drugs are still in the preapproval phase. Strict regulations governing such access define access criteria, data collection, non-promotion, and control of drug distribution.

Examples of circumstances where such access may be granted include:

  • A medicine for which no clinical alternative exists is still undergoing clinical trials;
  • A licensed medicine existed, but is discontinued, and an unlicensed alternative that does exist is still in development;
  • A product is awaiting approval in a particular country, but is licensed elsewhere in the world;
  • A local shortage exists for an essential medication; or
  • A patient has an immediate clinical need, but is not eligible for a trial, and the treating healthcare professional believes that the patient might benefit from taking the drug.

Companies such as BTG which are authorised to distribute on a named patient basis merely distribute and are not involved in the patient doctor relationship. All information regarding patients is controlled under specific privacy and data protection legislation. BTG can only distribute where permitted to do so and only in reponse to an unsolicited information or product supply request.

Our list of Named Patient Distributors is organised according to territory.

Please note: this contact information is intended for healthcare professionals only.

Unless otherwise noted below contact the following Named Patient Distributors:

DigiFab® (digoxin immune fab (ovine))
or Voraxaze® (glucarpidase)

Clinigen Healthcare Ltd

Pitcairn House
Crown Square
First Avenue
Burton-on-Trent
DE14 2WW

Tel: +44 (0)1283 494340
Fax: +44 (0)1283 494341
Email: customer.services@clinigengroup.com
Website: http://www.clinigengroup.com

CroFab® (crotalidae polyvalent immune fab (ovine))

Protherics Medicines Development Ltd, a BTG International group company

Blaenwaun, Ffostrasol
Llandysul, Ceredigion, SA44 5JT
United Kingdom+A7

Tel: +44 (0)1239 851 122
Fax: +44 (0)1239 800 087
(9am - 5pm, Monday - Friday, UK time, excluding UK public holidays)
Email: productsupplies@btgplc.com

Please select a country from the drop down list below which identifies the relevant agent as well as the products available.

  • Australia

    DigiFab® (digoxin immune fab (ovine))

    Phebra Pty Ltd

    DigiFab® (digoxin immune fab (ovine)) is approved for sale in this territory. Please refer to our Customer Service information in the Contact Us section, accessible through links at the top and bottom of this page.

    Tel: +61 (0)2 9420 9199 or +1 800 720 020
    Fax: +61 (0)2 9420 9177 or +1 800 100 013
    Email: orders@phebra.com
    Website: http://www.phebra.com

    Voraxaze® (glucarpidase)

    Phebra Pty Ltd

    19 Orion Road
    Lane Cove West
    NSW 2066
    Australia
    Tel: +61 (0)2 9420 9199 or +1 800 720 020
    Fax: +61 (0)2 9420 9177 or +1 800 100 013
    Email: orders@phebra.com
    Website: http://www.phebra.com
  • Canada

    DigiFab® (digoxin immune fab (ovine)) BTG International Inc.

    DigiFab® (digoxin immune fab (ovine)) is approved for sale in this territory. Please refer to our Customer Service information in the Contact Us section, accessible through links at the top and bottom of this page.

    Website: DigiFab® in Canada

  • Liechtenstein

    DigiFab® (digoxin immune fab (ovine))

    Curatis AG

    DigiFab® (digoxin immune fab (ovine)) is approved for sale in this territory. Please refer to our Customer Service information in the Contact Us section, accessible through links at the top and bottom of this page. 

    Tel: +0041 61 927 87 77
    Fax: +0041 61 927 87 75
    Email: info@curatis.com
    Website: www.curatis.com
  • New Zealand

    DigiFab® (digoxin immune fab (ovine))

    Phebra Pty Ltd

    19 Orion Road
    Lane Cove West
    NSW 2066
    Australia
    Tel: +61 (0)2 9420 9199 or +1 800 720 020
    Fax: +61 (0)2 9420 9177 or +1 800 100 013
    Email: orders@phebra.com
    Website: http://www.phebra.com/

    Voraxaze® (glucarpidase)

    Phebra Pty Ltd

    19 Orion Road
    Lane Cove West
    NSW 2066
    Australia
    Tel: +61 (0)2 9420 9199 or +1 800 720 020
    Fax: +61 (0)2 9420 9177 or +1 800 100 013
    Email: orders@phebra.com
    Website: http://www.phebra.com/
  • Saudi Arabia

    DigiFab® (digoxin immune fab (ovine))

    Al-Hobail

    Olaya Street
    Al Fahd Hotel 
    Spring Building
    4th Floor No: 401
    P.O. Box 61376
    Riyadh 11565
    Kingdom of Saudi Arabia
    Tel: +966920006647
    Fax: +966112013330
    Email: medical@al-hobail.com
    Website: http://www.al-hobail.com
  • Switzerland

    DigiFab® (digoxin immune fab (ovine))

    Curatis AG

    DigiFab® (digoxin immune fab (ovine)) is approved for sale in this territory. Please refer to our Customer Service information in the Contact Us section, accessible through links at the top and bottom of this page.

    Tel: +0041 61 927 87 77
    Fax: +0041 61 927 87 75
    Email: info@curatis.com
    Website: www.curatis.com
  • United States of America

    CroFab® (crotalidae polyvalent immune fab (ovine))

    BTG International Inc.

    CroFab® (crotalidae polyvalent immune fab (ovine)) is approved for sale in this territory. Please refer to our Customer Service information in the Contact Us section, accessible through links at the top and bottom of this page.

    Website: http://www.crofab.com/

    DigiFab® (digoxin immune fab (ovine))

    BTG International Inc.

    DigiFab® (digoxin immune fab (ovine)) is approved for sale in this territory. Please refer to our Customer Service information in the Contact Us section, accessible through links at the top and bottom of this page.

    Website: http://www.digifab.us.com

    Voraxaze® (glucarpidase)

    BTG International Inc.

    Voraxaze® (glucarpidase) is approved for sale in this territory. Please refer to our Customer Service information in the Contact Us section, accessible through links at the top and bottom of this page.

    Website: https://www.voraxaze.com/