What's new

Date Content
29/03/2018 Orphan designation: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (darvadstrocel) for the: Treatment of anal fistula, 08/10/2009, Positive
29/03/2018 Human medicines European public assessment report (EPAR): IDflu, influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type), Influenza, Human, Immunization, 24/02/2009, 13, Withdrawn
28/03/2018 Orphan designation: Recombinant fusion protein linking coagulation factor VIIa with albumin for the: Treatment of congenital factor VII deficiency, 07/10/2013, Positive
28/03/2018 Orphan designation: Alpha1-proteinase inhibitor (inhalation use) for the: Treatment of cystic fibrosis, 14/09/2007, Positive
28/03/2018 Orphan designation: Human alpha1-proteinase inhibitor for the: Treatment of emphysema secondary to congenital alpha1-antitrypsin deficiency, 09/07/2001, Positive
28/03/2018 Orphan designation: C1-esterase-inhibitor human for the: Treatment in solid organ transplantation, 12/10/2017, Positive
28/03/2018 Orphan designation: Recombinant fusion protein linking human coagulation factor IX with human albumin for the: Treatment of haemophilia B, 04/02/2010, Positive
28/03/2018 Procedures for monograph and list entry establishment
28/03/2018 Herbal medicinal product: Herniariae herba, Herniariae herba, D: Draft under discussion
28/03/2018 Herbal medicinal product: Menyanthidis trifoliatae folium, Menyanthidis trifoliatae folium, D: Draft under discussion