GMO medicinal products for human use
The products that have received a marketing authorisation so far, are listed below with the corresponding date of authorisation (for more details on the product and the authorisation procedure click on the corresponding link):
- Fluenz (vaccine, 27/01/2011) - withdrawn on 03/12/2014 and replaced by Fluenz Tetra (04/12/2013)
- Glybera (autologous cell and gene therapy, 25/10/2012)
- Imlygic (autologous cell and gene therapy (cancer treatment), 16/12/2015)
- Pandemic influenza vaccine H5N1 (20/05/2016)
- Strimvelis (autologous cell and gene therapy, 26/05/2016)
- Zalmoxis (autologous cell and gene therapy (cancer treatment), 18/08/2016)
- Kymriah (autologous cell and gene therapy (cancer treatment), 22/08/2018)
- Yescarta (autologous cell and gene therapy (cancer treatment), 23/08/2018)
- Luxturna (autologous cell and gene therapy, 22/11/2018)
- Dengvaxia (vaccine, 12/12/2018)
- Zynteglo (autologous cell and gene therapy, 04/06/2019)
- Ervebo (vaccine, 11/11/2019)
- Vaxchora (vaccine, 01/04/2020)
- Zolgensma (autologous cell and gene therapy, 18/05/2020)
- ZABDENO (vaccine, 01/07/2020)
- MVABEA (vaccine, 01/07/2020)
- Libmeldy (autologous cell and gene therapy, 16/10/2020)
- Tecartus (CAR-T cell therapy, 14/12/2020)
- Vaxzevria (Astrazeneca) (vaccine, 29/01/2021)
- Ad26_COV2_S COVID-19 Vaccine Janssen (11/03/2021)
- Abecma (autologous cell and gene therapy (cancer treatment), 18/08/2021)
- Skysona (autologous cell and gene therapy, Withdrawn)
- Breyanzi (autologous cell and gene therapy (cancer treatment), 04/04/2022)
- Carvykti (autologous cell and gene therapy (cancer treatment), 30/05/2022)
- Upstaza (treatment of neurometabolic disease, 18/07/2022)
- Roctavian (previously Roxavvy) (treatment against bleeding disorder, 24/08/2022)
- Qdenga (vaccine, 05/12/2022)
- Hemgenix (treatment against bleeding disorder, 20/02/2023)
GMO medicinal products for veterinary use
Several GMO medicinal products for veterinary use have been granted a marketing authorisation in the EU. Most of these products are vaccines, one is a treatment against cancer (Oncept IL-2).
Two of them were authorised under Directive 90/220/EEC:
- A vaccine against the porcine Aujeszky disease (genetically modified virus), authorised in December 1992 (authorisation amended in July 1994 – Decision 94/505/EC – to cover a new form of administration);
- The Raboral recombinant vaccine for preventing rabies in foxes (see text box on the right), authorised in October 1993 (Decision 93/572/EEC).
The other products have been processed under Regulation (EEC) No. 2309/93 (between 1993 and 2004) or Regulation (EC) 726/2004.
All these GMO medicinal products for veterinary use are listed below with the corresponding date of authorisation. For more details on the product and the authorisation procedure click on the corresponding link.
- Nobi-Porvac Aujeszky (18/12/1992 & 18/07/1994)
- Raboral V-RG (19/10/1993)
- Suvaxyn Aujeszky (07/08/1998)
- Purevax FeLV (formerly Eurifel FeLV) (13/04/2000 - withdrawn in 2007 - no renewal requested)
- Purevax RCP FeLV (formerly Eurifel RCP FelV) (08/03/2002)
- Vaxxitek HVT + IBD (formerly Gallivac HVT IBD) (9/08/2002)
- ProteqFLU (6/03/2003)
- ProteqFLU-Te (6/03/2003)
- Equilis StrepE (07/05/2004)
- Hiprabovis IBR marker live (27/01/2011)
- Purevax rabies (18/02/2011)
- Proteq West Nile (5/08/2011)
- Nobivac Myxo-RHD (07/09/2011)
- Poulvac E. coli (15/06/2012)
- Oncept IL-2 (03/05/2013)
- Bovela (22/12/2014)
- Suvaxyn CSF Marker (10/02/2015)
- Innovax-ILT (03/07/2015)
- Vectormune ND (08/09/2015)
- Vectormune FP ILT + AE (24/04/2020)
- Prevexxion RN (20/07/2020)
- Prevexxion RN HVT IBD (20/07/2020)
- Innovax ND-ILT (16/09/2020)
- Nobivac DP plus (09/10/2020)
- Ultifend ND IBD (20/04/2021)