Capex

13-6-2018

Orphan designation: 2-Ethylbutyl (2S)-2-{[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate (remdesivir), for the: Treatment of Ebola virus disease

Europe - EMA - European Medicines Agency

30-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak

FDA - U.S. Food and Drug Administration

30-5-2018

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

24-5-2018

Veterinary medicine European public assessment report (EPAR): Suvaxyn PRRS MLV, Porcine respiratory and reproductive syndrome virus vaccine (live), Revision: 1, Authorised

Europe - EMA - European Medicines Agency

23-5-2018

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (HIV).

FDA - U.S. Food and Drug Administration

18-5-2018

Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara virus, Revision: 13, Authorised

Europe - EMA - European Medicines Agency

17-5-2018

Veterinary medicine European public assessment report (EPAR): BTVPUR AlSap 1, bluetongue-virus serotype-1 antigen, Revision: 4, Withdrawn

Europe - EMA - European Medicines Agency

17-5-2018

Orphan designation: genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII, for the: Treatment of epidermolysis bullosa

Europe - EMA - European Medicines Agency

16-5-2018

Veterinary medicine European public assessment report (EPAR): BTVPUR Alsap 8, adjuvanted bluetongue virus vaccine, Revision: 5, Withdrawn

Europe - EMA - European Medicines Agency

2-5-2018

Veterinary medicine European public assessment report (EPAR): Purevax RCPCh FeLV, Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia, feline leukaemia and feline Chlamydophila virus infections, Revision: 9, Authorise

Europe - EMA - European Medicines Agency

2-5-2018

Veterinary medicine European public assessment report (EPAR): Purevax RCPCh, vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline Chlamydophila virus infections, Revision: 11, Authorised

Europe - EMA - European Medicines Agency

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety

1-6-2018

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Active substance: Bluetongue Virus Serotype 2 antigen - Bluetongue Virus Serotype 4 antigen) - Withdrawal (sunset clause) - No Commission Decision

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Active substance: Three human monoclonal antibodies against the Ebola virus glycoprotein) - Orphan designation - Commission Decision (2018)3395 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/18

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 8 (Merial)

BTVPUR AlSap 8 (Active substance: Bluetongue virus Serotype 8 Antigen) - Centralised - Withdrawal - Commission Decision (2018)3018 of Wed, 16 May 2018

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 1 (Merial)

BTVPUR AlSap 1 (Active substance: Bluetongue Virus Serotype 1 antigen) - Centralised - Withdrawal - Commission Decision (2018)3017 of Wed, 16 May 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Orphan designation - Commission Decision (2018)2408 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/17

Europe -DG Health and Food Safety

8-12-2017

Veterinary medicine European public assessment report (EPAR): Bovilis Blue-8, bluetongue virus vaccine, serotype 8 (inactivated), Revision: 0, Authorised

Europe - EMA - European Medicines Agency

21-9-2017

Veterinary medicine European public assessment report (EPAR): Innovax-ND-IBD, cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus, Revision: 0, Authorised

Europe - EMA - European Medicines Agency

20-6-2017

Veterinary medicine European public assessment report (EPAR): Respiporc FLUpan H1N1, inactivated influenza A virus/human strain: A/Jena/VI5258/2009(H1N1)pdm09, Revision: 0, Authorised

Europe - EMA - European Medicines Agency