Capex

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Pending EC decision: Respiporc FLUpan H1N1, inactivated influenza A virus/human strain: A/Jena/VI5258/2009(H1N1)pdm09, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision: Versican Plus DHPPi/L4R, canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision: Versican Plus DHPPi, canine distemper, canine adenovirus, canine parvovirosis and canine parainfluenza virus vaccine (live attenuated), Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision: Versican Plus DHPPi/L4, canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision: Versican Plus Pi, canine parainfluenza virus vaccine (live attenuated), Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision: Versican Plus Pi/L4, Canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision: Versican Plus Pi/L4R, Canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Human medicines European public assessment report (EPAR): Rotarix, rotavirus vaccine, live, attenuated, Revision: 27, Authorised

Europe - EMA - European Medicines Agency

4-9-2018

Veterinary medicine European public assessment report (EPAR): Gripovac 3, inactivated influenza-A virus / swine, Revision: 1, Withdrawn

Europe - EMA - European Medicines Agency

4-9-2018

Veterinary medicine European public assessment report (EPAR): Porcilis PCV M Hyo, porcine circovirus (inactivated) and porcine enzootic pneumonia vaccine, Revision: 4, Authorised

Europe - EMA - European Medicines Agency

31-8-2018

Human medicines European public assessment report (EPAR): Rotarix, rotavirus vaccine, live, attenuated, Revision: 26, Authorised

Europe - EMA - European Medicines Agency

23-8-2018

Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus 9-valent vaccine (recombinant, adsorbed), Revision: 8, Authorised

Europe - EMA - European Medicines Agency

14-8-2018

Veterinary medicine European public assessment report (EPAR): Suvaxyn PRRS MLV, Porcine respiratory and reproductive syndrome virus vaccine (live), Revision: 2, Authorised

Europe - EMA - European Medicines Agency

26-7-2018

Opinion/decision on a Paediatric investigation plan (PIP): -, Influenza virus H1 haemagglutinin / influenza virus H3 haemagglutinin /influenza virus haemagglutinin from strain B Victoria lineage / influenza virus haemagglutinin from strain B Yamagata l

Europe - EFSA - European Food Safety Authority EFSA Journal

26-7-2018

Veterinary medicine European public assessment report (EPAR): Bovilis Blue-8, bluetongue virus vaccine, serotype 8 (inactivated), Revision: 1, Authorised

Europe - EMA - European Medicines Agency

23-7-2018

Orphan designation: Three human monoclonal antibodies against the EBOV glycoprotein, for the: Treatment of Ebola virus disease

Europe - EMA - European Medicines Agency

28-6-2018

Human medicines European public assessment report (EPAR): Silgard, human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed), Revision: 33, Authorised

Europe - EMA - European Medicines Agency

28-6-2018

Orphan designation: Letermovir, for the: Treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity

Europe - EMA - European Medicines Agency

28-6-2018

Orphan designation: (S)-{8-Fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3, 4-dihydro-4-quinazolinyl} acetic acid (letermovir), for the: Prevention of cytomegalovirus disease in patients with impaired cell-m

Europe - EMA - European Medicines Agency

27-6-2018

Human medicines European public assessment report (EPAR): Gardasil, human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed), Revision: 38, Authorised

Europe - EMA - European Medicines Agency

26-6-2018

Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed), Revision: 31, Authorised

Europe - EMA - European Medicines Agency

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

28-5-2018

Pending EC decision: Porcilis PCV M Hyo, porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated), Opinion date: 25-May-2018

Europe - EMA - European Medicines Agency

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

22-8-2018

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (Active substance: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene) - Orphan designation - Commission Decision (2018)5274 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/18

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Active substance: Inactivated porcine parvovirus, strain NADL-2 / Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018) 4354 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

29-6-2018

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Active substance: Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)4166 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/3796/II/7

Europe -DG Health and Food Safety

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

20-4-2018

Veterinary medicine European public assessment report (EPAR): Suvaxyn Circo, porcine circovirus vaccine (inactivated, recombinant), Revision: 0, Authorised

Europe - EMA - European Medicines Agency

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

9-2-2018

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Active substance: Porcine circovirus vaccine (inactivated, recombinant)) - New authorisation - Commission Decision (2018)861 of Fri, 09 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4242

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