ERYPRO IU

22-8-2019

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

Europe - EMA - European Medicines Agency

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

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

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Human medicines European public assessment report (EPAR): Prialt, ziconotide, Revision: 21, Authorised

Europe - EMA - European Medicines Agency

21-9-2018

Human medicines European public assessment report (EPAR): Hulio, adalimumab, Revision: 0, Authorised

Europe - EMA - European Medicines Agency

21-9-2018

Human medicines European public assessment report (EPAR): Viekirax, ombitasvir / paritaprevir / ritonavir, Revision: 15, Authorised

Europe - EMA - European Medicines Agency

21-9-2018

Orphan designation: Recombinant human von Willebrand factor, for the: treatment of von Willebrand disease

Europe - EMA - European Medicines Agency

21-9-2018

Human medicines European public assessment report (EPAR): Darzalex, daratumumab, Revision: 6, Authorised

Europe - EMA - European Medicines Agency

20-9-2018

Human medicines European public assessment report (EPAR): Cimzia, certolizumab pegol, Revision: 22, Authorised

Europe - EMA - European Medicines Agency

20-9-2018

Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, Revision: 0, Authorised

Europe - EMA - European Medicines Agency

20-9-2018

Human medicines European public assessment report (EPAR): Fluenz Tetra, influenza vaccine (live attenuated, nasal), Revision: 14, Authorised

Europe - EMA - European Medicines Agency

20-9-2018

Human medicines European public assessment report (EPAR): Hemlibra, emicizumab, Revision: 2, Authorised

Europe - EMA - European Medicines Agency

19-9-2018

Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

19-9-2018

Human medicines European public assessment report (EPAR): Fortacin, lidocaine / prilocaine, Revision: 7, Authorised

Europe - EMA - European Medicines Agency

19-9-2018

Human medicines European public assessment report (EPAR): Kymriah, tisagenlecleucel, Revision: 0, Authorised

Europe - EMA - European Medicines Agency

19-9-2018

Human medicines European public assessment report (EPAR): Rasilez HCT, aliskiren / hydrochlorothiazide, Revision: 14, Authorised

Europe - EMA - European Medicines Agency

19-9-2018

Human medicines European public assessment report (EPAR): Ninlaro, ixazomib, Revision: 4, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Inductos, dibotermin alfa, Revision: 22, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Revision: 1, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Cholib, fenofibrate / simvastatin, Revision: 8, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Revision: 2, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Rapilysin, reteplase, Revision: 25, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil, Revision: 48, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Revinty Ellipta, fluticasone furoate / vilanterol, Revision: 15, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Xoterna Breezhaler, indacaterol / glycopyrronium bromide, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

18-9-2018

Human medicines European public assessment report (EPAR): Truvada, emtricitabine / tenofovir disoproxil, Revision: 38, Authorised

Europe - EMA - European Medicines Agency

17-9-2018

Human medicines European public assessment report (EPAR): Triumeq, abacavir sulfate / dolutegravir sodium / lamivudine, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

17-9-2018

Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Revision: 26, Authorised

Europe - EMA - European Medicines Agency

17-9-2018

Human medicines European public assessment report (EPAR): NeoRecormon, epoetin beta, Revision: 27, Authorised

Europe - EMA - European Medicines Agency

17-9-2018

Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol, Revision: 14, Authorised

Europe - EMA - European Medicines Agency

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

Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Revision: 12, Authorised

Europe - EMA - European Medicines Agency

14-9-2018

Human medicines European public assessment report (EPAR): Angiox, bivalirudin, Revision: 22, Withdrawn

Europe - EMA - European Medicines Agency

14-9-2018

Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Revision: 20, Authorised

Europe - EMA - European Medicines Agency

14-9-2018

Human medicines European public assessment report (EPAR): Alecensa, alectinib, Revision: 7, Authorised

Europe - EMA - European Medicines Agency

14-9-2018

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Revision: 24, Authorised

Europe - EMA - European Medicines Agency

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Human medicines European public assessment report (EPAR): Conbriza, bazedoxifene, Revision: 11, Authorised

Europe - EMA - European Medicines Agency

13-9-2018

Human medicines European public assessment report (EPAR): Bavencio, avelumab, Revision: 3, Authorised

Europe - EMA - European Medicines Agency

13-9-2018

Human medicines European public assessment report (EPAR): Lifmior, etanercept, Revision: 5, Authorised

Europe - EMA - European Medicines Agency

13-9-2018

Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Revision: 12, Authorised

Europe - EMA - European Medicines Agency

13-9-2018

Human medicines European public assessment report (EPAR): Rapamune, sirolimus, Revision: 37, Authorised

Europe - EMA - European Medicines Agency

13-9-2018

Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib, Revision: 3, Authorised

Europe - EMA - European Medicines Agency

13-9-2018

Human medicines European public assessment report (EPAR): Ecalta, anidulafungin, Revision: 16, Authorised

Europe - EMA - European Medicines Agency

13-9-2018

Human medicines European public assessment report (EPAR): Moventig, naloxegol, Revision: 6, Authorised

Europe - EMA - European Medicines Agency

13-9-2018

Bravo Packing, Inc. Recalls Performance Dog Raw Pet Food Because of Possible Salmonella Health Risk to Humans and Animals

Bravo Packing, Inc. of Carneys Point, NJ is recalling all Performance Dog products, a frozen raw pet food, because it has the potential to be contaminated with Salmonella. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products.

FDA - U.S. Food and Drug Administration

12-9-2018

Human medicines European public assessment report (EPAR): Nerlynx, neratinib, Revision: 0, Authorised

Europe - EMA - European Medicines Agency

12-9-2018

Human medicines European public assessment report (EPAR): Prolia, denosumab, Revision: 20, Authorised

Europe - EMA - European Medicines Agency

12-9-2018

Human medicines European public assessment report (EPAR): Parsabiv, etelcalcetide, Revision: 4, Authorised

Europe - EMA - European Medicines Agency

11-9-2018

Veterinary medicine European public assessment report (EPAR): Clynav, Salmon pancreas disease vaccine (recombinant DNA plasmid), Revision: 2, Authorised

Europe - EMA - European Medicines Agency

11-9-2018

Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib, Revision: 18, Authorised

Europe - EMA - European Medicines Agency

21-9-2018

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

17-9-2018

Agenda: Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP)

Europe - EMA - European Medicines Agency

17-9-2018

Agenda: Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP)

Europe - EMA - European Medicines Agency

17-9-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

17-9-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

17-9-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep-2018

This Patients' and Consumers' Working Party (PCWP) plenary meeting will include discussions on patient engagement along the regulatory lifecycle and visibility of patient input throughout scientific procedures. Feedback will also be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

13-9-2018

Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg)

Europe - EMA - European Medicines Agency

13-9-2018

Report: Medicinal products for human use: monthly figures - August 2018

Europe - EMA - European Medicines Agency

13-9-2018

Overview of comments received on 'the guideline Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94038/2007 Rev. 5) - Revision 5

Europe - EMA - European Medicines Agency