EU/3/04/243

Table of contents

About

On 16 November 2004, orphan designation (EU/3/04/243) was granted by the European Commission to BCG (Europe) Ltd, United Kingdom, for alpha-1 antitrypsin (inhalation use) for the treatment of cystic fibrosis.

The sponsorship was transferred to The Weinberg Group LLC, United Kingdom, in July 2007, then to The Weinberg Group Limited, United Kingdom, in April 2009 and subsequently to Innovative Drug European Associates Limited, United Kingdom, in December 2010.

In December 2012, Innovative Drug European Associates Limited changed name to IDEA Innovative Drug European Associates Limited.

The sponsorship was then transferred to Triskel EU Services Ltd., United Kingdom, in July 2013.

The sponsorship was transferred to Kamada Ireland Limited, Ireland, in April 2019.

Key facts

Active substance
Alpha-1 antitrypsin (inhalation use)
Disease / condition
Treatment of cystic fibrosis
Date of first decision
16/11/2004
Outcome
Positive
EU designation number
EU/3/04/243

Sponsor's contact details

Kamada Ireland Limited
163 Lower Kimmage Road
Kimmage
Dublin 6W
Ireland
Tel: +353 1492 4367
E-mail: seinmahl@triskel.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;

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