|
Ref.
|
Company
|
GMO
|
Advice of the Council
Consultation on the Environmental Risk Assessment
organised by EMA
|
More info about the dossier
|
|
Cerepro
|
Ark Therapeutics Ltd
|
Human adenovirus
serotype 5
deleted in E1 and E3 and
containing the Herpes simplex virus-thymidine kinase gene
|
02 Feb. 2007
Opinion on the dossier and the day 70 assessment report drafted by the Spanish competent authority
27 Oct. 2007
Opinion on the responses of the applicant on the Day 120 list of questions
|
26 Apr. 2007
Negative opinion of EMEA
Link to Website of EMEA
|
Hiprabovis IBR
marker live
|
Laboratorios HIPRA S.A. |
Bovine Herpes virus strain CEDDEL with deletion of the genes that code for glycoprotein E and the enzyme thymidine kinase |
15 June 2009
Opinion on the dossier and the day
70 assessment report drafted by the competent authority of UK
|
12 Nov. 2010
Positive opinion of EMA
27 Jan. 2011
Authorisation valid throughout the EU
Link to website of EMA |
| Fluenz |
MedImmune LLC |
Influenza virus reassortants |
8 April 2009
Opinion on the dossier and the day 80 assessment report drafted by the competent authorities of France and Belgium
17 June 2010
Opinion on the responses of the applicant on the Day 120 list of questions
13 September 2010
Opinion on the responses of the applicant on the Day 150 list of questions
|
21 October 2010
Positive opinion of EMA
27 Jan. 2011
Authorisation valid throughout the EU
Link to website of EMA
|
| Purevax rabies |
Merial |
Canarypox virus expressing the surface glycoprotein G gene from Rabies virus |
15 March 2010
Opinion on the dossier and the day 70 assessment report drafted by the competent authority of Belgium
28 October 2010
Opinion on the responses of the applicant on the Day 150 list of questions
|
8 December 2010
Positive opinion of EMA
18 Feb. 2011
Authorisation valid throughout the EU
Link to website of EMA |
| Proteq West Nile |
Merial |
Canarypox virus expressing the preM and E genes of West Nile virus |
26 August 2010
Opinion on the dossier and the day 70 assessment report drafted by the competent authorities of France
8 April 2011
Opinion on the responses of the applicant on the Day 120 list of questions
|
9 June 2011
Positive opinion of EMA
5 Aug. 2011
Authorisation valid throughout the EU
Link to website of EMA |
| Glybera |
Amsterdam Molecular Therapeutics |
Adeno-associated virus expressing a human lipoprotein lipase gene variant |
30 April 2011
Opinion on the dossier and the day 80 assessment report drafted by the EMA rapporteur
10 January 2011
Opinion on the responses of the applicant on the Day 120 list of questions
9 May 2011
Opinion on the responses of the applicant on the Day 150 list of questions |
24 June 2011
Negative opinion of EMA
Link to website of EMA |
| Nobivac Myxo-RHD |
Intervet International |
Myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus |
17 May 2010
Opinion on the dossier and the day 70 assessment report drafted by the EMA rapporteur |
14 July 2011
Positive opinion of EMA
7 Sept. 2011
Authorisation valid throughout the EU
Link to website of EMA |
