ERYPRO IU 1ML VIAL

22-8-2019

Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

20-2-2019

Salmonella control in poultry flocks and its public health impact

Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-2-2019

FDA Announces Second Approved Insulin for Use in Dogs with Diabetes

The FDA’s Center for Veterinary Medicine announced today the approval of ProZinc (protamine zinc recombinant human insulin) for managing diabetes mellitus in dogs, the second approved insulin for use in dogs with diabetes.

FDA - U.S. Food and Drug Administration

1-2-2019

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

EFSA statement on the risk posed to humans by a vitamin B2 produced by a genetically modified strain of Bacillus subtilis used as a feed additive

Published on: Thu, 31 Jan 2019 The detection of recombinant DNA in a vitamin B2 used as feed additive was notified by the Belgian national authorities on 2 October 2018 via the Rapid Alert System for Food and Feed (RASFF). The European Commission requested scientific advice from EFSA on the risk posed to humans by the presence of genetically modified material in the feed additive, particularly with regard to antimicrobial resistance (AMR). EFSA assessed the analytical data from RASFF regarding the prese...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Electronic product information for human medicines in the European Union – draft key principles

Europe - EMA - European Medicines Agency

26-1-2019

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Published on: Fri, 25 Jan 2019 Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 “In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants”. To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and cri...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Overview of available toxicity data for calystegines

Published on: Fri, 25 Jan 2019 Calystegines are polyhydroxylated nortropane alkaloids that have been found in various solanaceous foods, in particular in potatoes and aubergines. The biological activity and potential toxicity of calystegines are associated with their capacity to inhibit glycosidases and block carbohydrate metabolism inducing lysosomal storage toxicity. The present report summarises the retrieved information on the possible toxicity of calystegines. Only few in vivo short‐term toxicologi...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-1-2019

Agenda - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicine products

Europe - EMA - European Medicines Agency

25-1-2019

Industry stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicine products, European Medicines Agency, London, UK, from 28/01/2019 to 28/01/2019

Europe - EMA - European Medicines Agency

23-1-2019

Foot and mouth disease

Foot and mouth disease (FMD) is a highly contagious viral infection that is not transmissible to humans. It remains one of the main concerns of livestock farmers and health authorities, due to its potentially huge socio-economic impact. Below is a detailed review of ANSES’s work on FMD.

France - Agence Nationale du Médicament Vétérinaire

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-1-2019

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

ANSES has examined the ruling of 15 January 2019 by the French administrative court of Lyon overriding the marketing authorisation decision for Roundup Pro 360. It should be noted that, in order to protect human and environmental health, ANSES is responsible for implementing European regulations on the national level with regard to the marketing authorisation of regulated products (plant protection products, biocides and veterinary medicinal products). It also contributes to improving these regulations b...

France - Agence Nationale du Médicament Vétérinaire

17-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

Published on: Wed, 16 Jan 2019 Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. Th...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Start onderzoek ‘voltooid leven’

De Universiteit voor Humanistiek en het Julius Centrum van het UMCU gaan dit jaar samen onderzoek doen naar de omvang en omstandigheden van de groep mensen voor wie de huidige wetgeving geen ruimte lijkt te bieden voor hulp bij een zelfgekozen levenseinde.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Published on: Mon, 14 Jan 2019 Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify the original conclusions on their safety were identified. Th...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-2-2019

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Europe - EMA - European Medicines Agency

20-2-2019

Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Europe - EMA - European Medicines Agency

20-2-2019

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

Europe - EMA - European Medicines Agency

20-2-2019

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019

Orphan designation: human apotransferrin, Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019

Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

18-2-2019

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Active substance: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)1376 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003405

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (Active substance: Recombinant human lecithin cholesterol acyltransferase) - Transfer of orphan designation - Commission Decision (2019)1365 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003174

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (Active substance: Modified recombinant human C-type natriuretic peptide) - Transfer of orphan designation - Commission Decision (2019)1348 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003587

Europe -DG Health and Food Safety

14-2-2019

EU/3/17/1969 (Maria Livadiotis)

EU/3/17/1969 (Active substance: Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits) - Transfer of orphan designation - Commission Decision (2019)1357 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003568

Europe -DG Health and Food Safety

14-2-2019

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Active substance: Recombinant human monoclonal antibody to insulin receptor) - Transfer of orphan designation - Commission Decision (2019)1372 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003601

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1499 (Voisin Consulting S.A.R.L.)

EU/3/15/1499 (Active substance: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells) - Transfer of orphan designation - Commission Decision (2019)1375 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003671

Europe -DG Health and Food Safety

14-2-2019

EU/3/14/1394 (Pharma Gateway AB)

EU/3/14/1394 (Active substance: Pegylated recombinant human hyaluronidase PH20) - Transfer of orphan designation - Commission Decision (2019)1343 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002720

Europe -DG Health and Food Safety

14-2-2019

EU/3/14/1290 (Nightstar Europa Limited)

EU/3/14/1290 (Active substance: Adeno-associated viral vector serotype 2 containing the human REP1 gene) - Transfer of orphan designation - Commission Decision (2019)1361 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003290

Europe -DG Health and Food Safety

13-2-2019

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019

Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019

Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Europe - EMA - European Medicines Agency

13-2-2019

Human medicines highlights - February 2019

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

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

4-2-2019

Privigen (CSL Behring GmbH)

Privigen (Active substance: Human normal immunoglobulin (IVIg)) - Centralised - 2-Monthly update - Commission Decision (2019)841 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/831/IB/144

Europe -DG Health and Food Safety

4-2-2019

Respreeza (CSL Behring GmbH)

Respreeza (Active substance: human alpha1-proteinase inhibitor) - Centralised - Yearly update - Commission Decision (2019)842 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

4-2-2019

EU/3/12/1083 (Voisin Consulting S.A.R.L.)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2019)814 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003624

Europe -DG Health and Food Safety

1-2-2019

Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

31-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Fc- and CDR-modified humanized monoclonal antibody against C5, decision type: , therapeutic area: , PIP number: P/0261/2018

Europe - EMA - European Medicines Agency

31-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524), decision type: , therapeutic area: , PIP number: P/0285/2018

Europe - EMA - European Medicines Agency

31-1-2019

Human medicines European public assessment report (EPAR): Efgratin, pegfilgrastim, Neutropenia, Status: Pending

Europe - EMA - European Medicines Agency

31-1-2019

Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Neutropenia, Status: Pending

Europe - EMA - European Medicines Agency

31-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human alpha-galactosidase A (PRX 102), decision type: , therapeutic area: , PIP number: P/0286/2018

Europe - EMA - European Medicines Agency

30-1-2019

EU/3/16/1609 (Celerion Austria GmbH)

EU/3/16/1609 (Active substance: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s) - Transfer of orphan designation - Commission Decision (2019)234 of Wed, 30 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002887

Europe -DG Health and Food Safety

29-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, decision type: , therapeuti

Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, decision type: , therapeutic area: , PIP number: P/0290/2018

Europe - EMA - European Medicines Agency

28-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor (TBX-1400), decision type: , therapeutic area: , PIP number: P/0284/2018

Europe - EMA - European Medicines Agency

28-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision t

Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision type: , therapeutic area: , PIP number: P/0318/2018

Europe - EMA - European Medicines Agency

28-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C / trimeric, recombinant HIV-1 envelope glycoprotein 140 containing motifs of multiple HIV-1 variants, adjuvanted with aluminium ph

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C / trimeric, recombinant HIV-1 envelope glycoprotein 140 containing motifs of multiple HIV-1 variants, adjuvanted with aluminium phosphate [Clade C gp140/ Mosaic gp140], decision type: , therapeutic area: , PIP number: P/0237/2018

Europe - EMA - European Medicines Agency

28-1-2019

Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

28-1-2019

Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

23-1-2019

Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody, Treatment of neuromyelitis optica spectrum disorders, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

23-1-2019

Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201805

Europe - EMA - European Medicines Agency

22-1-2019

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (Active substance: Chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2) - Transfer of orphan designation - Commission Decision (2019)575 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003313

Europe -DG Health and Food Safety

22-1-2019

Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, Date of authorisation: 07/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

17-1-2019

Holoclar (Chiesi Farmaceutici S.p.A.)

Holoclar (Active substance: Ex vivo expanded autologous human corneal epithelial cells containing stem cells) - Centralised - Annual renewal - Commission Decision (2019)272 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2450/R/21

Europe -DG Health and Food Safety

17-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Europe - EMA - European Medicines Agency

17-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Europe - EMA - European Medicines Agency

15-1-2019

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Orphan designation - Commission Decision (2019)222 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001592

Europe -DG Health and Food Safety

15-1-2019

Hizentra (CSL Behring GmbH)

Hizentra (Active substance: human normal immunoglobulin) - Centralised - 2-Monthly update - Commission Decision (2019)195 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2127/II/97G

Europe -DG Health and Food Safety

15-1-2019

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Active substance: Humanised anti-IL-6 receptor monoclonal antibody) - Transfer of orphan designation - Commission Decision (2019)229 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003065

Europe -DG Health and Food Safety

ERYPRO IU

Main information

Documents

Localization

Other information

Status