Capex

21-12-2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Workshop on Avian Influenza

Published on: Wed, 19 Dec 2018 Since September 2017, EFSA has been providing ongoing scientific and technical support to the European Commission and Member States (MSs) in the collection, collation, and analysis of epidemiological data relevant to the monitoring of avian influenza (AI) viruses in Europe and third countries. From 2019 onwards, EFSA will also be responsible for collecting, collating, and analysing the data gathered by MSs via their surveillance programmes in poultry and wild birds. To eff...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA - U.S. Food and Drug Administration

30-11-2018

Reporting Avian Influenza surveillance

Published on: Thu, 29 Nov 2018 Avian influenza viruses infect domestic poultry and wild birds as well as humans. In poultry, depending on whether these viruses are of high pathogenicity (HPAI) or low pathogenicity (LPAI), the infection can cause different clinical signs, with HPAI causing high mortality in poultry flocks. In order to ensure early detection of avian influenza viruses, surveillance in poultry and wild birds is considered essential. In 2010, the European Commission provided some guidelines...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

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

12-2-2019

Vaxxitek HVT + IBD (Merial)

Vaxxitek HVT + IBD (Active substance: Live vHVT013-69 recombinant virus) - Centralised - Yearly update - Commission Decision (2019)1098 of Tue, 12 Feb 2019

Europe -DG Health and Food Safety

5-2-2019

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1), decision type: , therapeutic area: , PIP number: P/0249/2018

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1), decision type: , therapeutic area: , PIP number: P/0249/2018

Europe - EMA - European Medicines Agency

28-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), decision type: , therapeutic area: , PIP number: P/0341/2018

Europe - EMA - European Medicines Agency

11-1-2019

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)) - New authorisation - Commission Decision (2019)135 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/V/C/4611

Europe -DG Health and Food Safety

11-1-2019

Parvoduk (Merial)

Parvoduk (Active substance: Muscovy duck parvovirus vaccine (live)) - Centralised - Renewal - Commission Decision (2019)133 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2740/R/6

Europe -DG Health and Food Safety

7-1-2019

Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Europe - EMA - European Medicines Agency

7-1-2019

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Europe - EMA - European Medicines Agency

20-12-2018

Nobilis IB Primo QX (Intervet International B.V.)

Nobilis IB Primo QX (Active substance: Live avian infectious bronchitis virus, strain D388) - Centralised - Yearly update - Commission Decision (2018)9136 of Thu, 20 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

Ingelvac CircoFLEX (Boehringer Ingelheim Vetmedica GmbH)

Ingelvac CircoFLEX (Active substance: Porcine circovirus type 2 ORF2 protein minimum RP1.0 Maximum RP 3.75) - Centralised - Yearly update - Commission Decision (2018)9073 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2109 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2109 (Active substance: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase) - Orphan designation - Commission Decision (2018)9024 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/153/18

Europe -DG Health and Food Safety

12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein

Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein

Europe - EMA - European Medicines Agency

12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin

Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin

Europe - EMA - European Medicines Agency

27-11-2018

Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), decision type: , therapeutic area: , PIP number: P/0219/2018

Opinion/decision on a Paediatric investigation plan (PIP): Purified inactivated rabies virus (WISTAR PM/WI 38-1503-3M strain), decision type: , therapeutic area: , PIP number: P/0219/2018

Europe - EMA - European Medicines Agency

27-11-2018

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split i

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split influenza virus, inactivated containing antigens equivalent to the B-like strain, decision type: , therapeutic area: , PIP number: P/0155/2018

Europe - EMA - European Medicines Agency

27-11-2018

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage, decision type: , therapeutic area: , PIP

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage, decision type: , therapeutic area: , PIP number: P/0211/2018

Europe - EMA - European Medicines Agency

22-11-2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant varicella zoster virus (VZV) glycoprotein E, decision type: , therapeutic area: , PIP number: P/0222/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant varicella zoster virus (VZV) glycoprotein E, decision type: , therapeutic area: , PIP number: P/0222/2018

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

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