IG VENA 10 GR 200

22-8-2019

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

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

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

29-11-2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

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

19-9-2018

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

Europe - EMA - European Medicines Agency

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

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

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

6-9-2018

Human medicines European public assessment report (EPAR): Jetrea, ocriplasmin, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

5-9-2018

Human medicines European public assessment report (EPAR): Telmisartan Teva, telmisartan, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Human medicines European public assessment report (EPAR): Lojuxta, lomitapide, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

3-9-2018

Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

3-9-2018

Human medicines European public assessment report (EPAR): Opsumit, macitentan, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

24-8-2018

Human medicines European public assessment report (EPAR): HyQvia, human normal immunoglobulin, Revision: 12, Authorised

Europe - EMA - European Medicines Agency

24-8-2018

Imagine recalls Buckyballs magnet sets

Health Canada has determined that these magnet sets are a danger to human health and safety because they contain small powerful magnets which can be easily swallowed or inhaled by children. Unlike other small objects that would be more likely to pass normally through the digestive system if swallowed, when more than one small powerful magnet is swallowed, the magnets can attract one another while travelling through the digestive system. The magnets can then pinch together and create a blockage and slowly...

Health Canada

10-8-2018

Human medicines European public assessment report (EPAR): Sevelamer carbonate Zentiva, sevelamer carbonate, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

10-8-2018

Human medicines European public assessment report (EPAR): Mysimba, naltrexone / bupropion, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

7-8-2018

Human medicines European public assessment report (EPAR): Levetiracetam Sun, levetiracetam, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

1-8-2018

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

Europe - EMA - European Medicines Agency

24-7-2018

Orphan designation: Glucagon analogue linked to a human immunoglobulin Fc fragment, for the: Treatment of congenital hyperinsulinism

Europe - EMA - European Medicines Agency

20-7-2018

Scientific guideline: Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 3, adopted

Europe - EFSA - European Food Safety Authority EFSA Journal

20-7-2018

Scientific guideline: Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 5, adopted

Europe - EFSA - European Food Safety Authority EFSA Journal

19-7-2018

Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

18-7-2018

Human medicines European public assessment report (EPAR): Fertavid, follitropin beta, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

18-7-2018

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

18-7-2018

Human medicines European public assessment report (EPAR): Controloc Control, pantoprazole, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

13-7-2018

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

Europe - EMA - European Medicines Agency

6-7-2018

Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

5-7-2018

Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

4-7-2018

Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

21-6-2018

Human medicines European public assessment report (EPAR): Brimica Genuair, aclidinium / formoterol fumarate dihydrate, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

21-6-2018

Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide / formoterol, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP): -, Adeno-associated viral vector serotype rh.10 carrying the humanNsulfoglucosamine Nsulfoglucosamine sulfohydrolase cDNA (LYS-SAF302), Therapeutic area: Neurology

Europe - EFSA - European Food Safety Authority EFSA Journal

15-6-2018

Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

13-6-2018

Human medicines European public assessment report (EPAR): Plenadren, hydrocortisone, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

13-6-2018

Human medicines European public assessment report (EPAR): Tybost, cobicistat, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

12-6-2018

Human medicines European public assessment report (EPAR): Zutectra, human hepatitis-B immunoglobulin, Revision: 12, Authorised

Europe - EMA - European Medicines Agency

6-6-2018

Orphan designation: Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein, for the: Treatment of X-linked hypohidrotic ectodermal dysplasia (Christ-Siemens-Touraine Syndrome)

Europe - EMA - European Medicines Agency

31-5-2018

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

Europe - EMA - European Medicines Agency

14-12-2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Europe - EMA - European Medicines Agency

12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

6-12-2018

Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803

Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803

Europe - EMA - European Medicines Agency

22-11-2018

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Active substance: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor) - Orphan designation - Commission Decision (2018)7798 of Wed, 21 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Active substance: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast) - Orphan designation - Commission Decision (2018)7797 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/134/18

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

13-9-2018

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

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

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

4-6-2018

EU/3/05/334 (Florence Porte ThomE)

EU/3/05/334 (Active substance: Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein) - Transfer of orphan designation - Commission Decision (2018)3629 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/05/T/03

Europe -DG Health and Food Safety