ՌԲՈՒ-200

main_info

  • trade_name:
  • ՌԲՈՒ-200
  • dosage:
  • 200մգ(100/10x10/) բլիստերում
  • pharmaceutical_form:
  • դեղահատեր թաղանթապատ
  • prescription_type:
  • Առանց դեղատոմսի
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • ՌԲՈՒ-200
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

  • source:
  • Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում - Armenia
  • last_update:
  • 31-05-2018

18-4-2019

Systematic review on health outcomes related to the age of introduction of complementary food

Systematic review on health outcomes related to the age of introduction of complementary food

Published on: Wed, 17 Apr 2019 In 2016, the European Commission gave EFSA a mandate to update its 2009 opinion on the appropriate age for introduction of complementary feeding of infants. In order to retrieve data on health outcomes related to the age of introduction of complementary food, a systematic literature review will be conducted by EFSA. This report presents the preparatory work that is performed by Pallas, with advice of Wageningen University, for the systematic literature review. It provides ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-4-2019

Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection)

Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection)

Published on: Thu, 11 Apr 2019 According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-4-2019

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Mon, 15 Apr 2019 Following an application from H.J. Heinz Supply Chain Europe B.V. submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respirator...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-4-2019

Setting an import tolerance for 2,4‐D in soyabeans

Setting an import tolerance for 2,4‐D in soyabeans

Published on: Fri, 12 Apr 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Greece to set an import tolerance for the active substance 2,4‐D in genetically modified (GM) soyabeans imported from Canada and the USA. The genetic modification confers tolerance to the herbicide 2,4‐D. The data submitted in support of the request provided sufficient evidence to conclude that residues of parent 2,4‐D and o...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-4-2019

Toxicity reference values (TRVs)

Toxicity reference values (TRVs)

As part of its missions and under the French National Environmental & Health Action Plan (2004-2008), the Agency began a national programme on TRVs in 2004 with the aim of building solid French expertise that could be shared by the various competent authorities in this area.

France - Agence Nationale du Médicament Vétérinaire

11-4-2019

Evaluation of confirmatory data following the Article 12 MRL review for dimethenamid‐P

Evaluation of confirmatory data following the Article 12 MRL review for dimethenamid‐P

Published on: Wed, 10 Apr 2019 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethenamid‐P in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap refers to the submission of a plant metabolism study investigating the fate of dimethenamid‐P following foliar treatment with a short preharvest interval (PHI) in a leafy or bu...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-4-2019

Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances

Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances

Published on: Mon, 08 Apr 2019 This document provides guidance to applicants submitting dossiers for approval of pesticide active substances, and to Member States preparing assessment reports on active substances within the scope of Regulation (EC) No 1107/2009 and Commission Implementing Regulation (EU) No 844/2012 and its subsequent amendments. It describes the administrative requirements for the preparation and submission of the dossier to support an application for the approval, the amendment of ap...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-4-2019

Safety and efficacy of Hemicell®‐L (endo‐1,4‐β‐mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

Safety and efficacy of Hemicell®‐L (endo‐1,4‐β‐mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

Published on: Mon, 01 Apr 2019 The additive Hemicell®‐L is a liquid preparation of endo‐1,4‐β‐mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and cons...

Europe - EFSA - European Food Safety Authority EFSA Journal

29-3-2019

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for gamma‐cyhalothrin in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for gamma‐cyhalothrin in light of confirmatory data

Published on: Thu, 28 Mar 2019 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-3-2019

Peer review of the pesticide risk assessment of the active substance thiacloprid

Peer review of the pesticide risk assessment of the active substance thiacloprid

Published on: Thu, 14 Mar 2019 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiaclopr...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

Published on: Tue, 05 Mar 2019 A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions is the subject of this assessment. The active substance is considered to be CLA (t10,c12) methyl ester (ME). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA previously issued an opinion on the safety and efficacy of the product, in which it could not conclude on the efficacy of this additive for sows for reproduction and for cows f...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-3-2019

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Pest categorisation of the Ralstonia solanacearum species complex

Pest categorisation of the Ralstonia solanacearum species complex

Published on: Fri, 22 Feb 2019 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of the Ralstonia solanacearum species complex (RSSC), a distinguishable cosmopolitan group of bacterial plant pathogens (including R. solanacearum, Ralstonia pseudosolanacearum and two subspecies of Ralstonia syzygii) of the family Burkholderiaceae. The RSSC causes bacterial wilt in solanaceous crops, such as potato, tomato and pepper, but can also cause wilts i...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

Published on: Fri, 22 Feb 2019 This report describes the tasks performed in the period 1/3/2017 to 27/11/2018 under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 on toxicological studies and animal feeding studies included in applications for market authorisation of genetically modified feed/plants under Regulation (EC) No 1829/2003. The tasks cover the check for study adherence to relevant EFSA guidance documents and to OECD Test Guideline no 407 (1995/2008), OECD Test Guideline no 408 (1998) and OECD P...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food

American consumers expect a diverse, robust and fresh food supply that’s affordable and safe all year round. Since not all food products can be produced solely by domestic facilities, to help meet these demands, the U.S. imports about 15 percent of its overall food supply from more than 200 countries or territories representing about 125,000 international food facilities and farms. Over the past 15 years alone, we’ve seen a trend of rising imported foods. Other countries now supply about 32 percent of th...

FDA - U.S. Food and Drug Administration

16-2-2019

Outcome of the consultation with Member States and EFSA on the basic substance application for L‐cysteine for use in plant protection as insecticide

Outcome of the consultation with Member States and EFSA on the basic substance application for L‐cysteine for use in plant protection as insecticide

Published on: Fri, 15 Feb 2019 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for L‐cysteine are presented. The context of the evaluation was that required by ...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-2-2019

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 12 Feb 2019 According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance. Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified 13 active substances for which a review of MRLs i...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for flutolanil

Evaluation of confirmatory data following the Article 12 MRL review for flutolanil

Published on: Mon, 04 Feb 2019 The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to new residue trials for globe artichokes and beans with pods and for storage stability data in products of animal origin were addressed. Further risk mana...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for spinosad

Evaluation of confirmatory data following the Article 12 MRL review for spinosad

Published on: Mon, 04 Feb 2019 The applicant Dow AgroSciences Ltd submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for spinosad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to residue trials on globe artichokes, flowering brassica and the nature of residues in processed commodities were satisfactorily addressed. A new feedi...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for imazamox

Evaluation of confirmatory data following the Article 12 MRL review for imazamox

Published on: Fri, 01 Feb 2019 The applicant BASF SE submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for imazamox in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, the applicant submitted new residue trials on rice. Since the number of trials was not sufficient, the data gap was considered only partially addressed. The remaining dat...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Review of the existing maximum residue levels for imidacloprid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for imidacloprid according to Article 12 of Regulation (EC) No 396/2005

Published on: Thu, 31 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance imidacloprid. To assess the occurrence of imidacloprid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the import to...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Modification of the existing maximum residue levels for sulfoxaflor in various crops

Modification of the existing maximum residue levels for sulfoxaflor in various crops

Published on: Thu, 31 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in various crops, including limes imported from Australia. The data submitted in support of the request were found to be sufficient to derive MRL proposals for limes, cauliflowers, Brussels sprouts, kales, spinaches and similar ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Review of the existing maximum residue levels for hexythiazox according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for hexythiazox according to Article 12 of Regulation (EC) No 396/2005

Published on: Thu, 31 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance hexythiazox. To assess the occurrence of hexythiazox residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Commission as well a...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-1-2019

Review of the existing maximum residue levels for spiromesifen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for spiromesifen according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 23 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance spiromesifen. To assess the occurrence of spiromesifen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission, as well as the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Modification of the existing maximum residue levels for spirotetramat in various crops

Modification of the existing maximum residue levels for spirotetramat in various crops

Published on: Fri, 18 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium prepared a request to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in Florence fennels and rhubarbs. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to modify the existing MRLs for spirotetramat in the group of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic ar

Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic ar

Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic area: , PIP number: P/0022/2019

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2, Treatment of shiga-toxin-producing bacterial infection, 26/08/2005, Positive

Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2, Treatment of shiga-toxin-producing bacterial infection, 26/08/2005, Positive

Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2, Treatment of shiga-toxin-producing bacterial infection, 26/08/2005, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: cholest-4-en-3-one, oxime, Treatment of 5q spinal muscular atrophy, 10/03/2005, Withdrawn

Orphan designation: cholest-4-en-3-one, oxime, Treatment of 5q spinal muscular atrophy, 10/03/2005, Withdrawn

Orphan designation: cholest-4-en-3-one, oxime, Treatment of 5q spinal muscular atrophy, 10/03/2005, Withdrawn

Europe - EMA - European Medicines Agency

26-3-2019


Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: Treprostinil diethanolamine (oral use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 26/08/2005, Positive

Orphan designation: Treprostinil diethanolamine (oral use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 26/08/2005, Positive

Orphan designation: Treprostinil diethanolamine (oral use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 26/08/2005, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: Treprostinil diethanolamine, Treatment of systemic sclerosis, 15/05/2009, Positive

Orphan designation: Treprostinil diethanolamine, Treatment of systemic sclerosis, 15/05/2009, Positive

Orphan designation: Treprostinil diethanolamine, Treatment of systemic sclerosis, 15/05/2009, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145)

Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145)

Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004), decision type: , therapeutic area: , PIP number: P/0210/2012

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Ciprofloxacin (inhalation use), Treatment of cystic fibrosis, 03/08/2007, Withdrawn

Orphan designation: Ciprofloxacin (inhalation use), Treatment of cystic fibrosis, 03/08/2007, Withdrawn

Orphan designation: Ciprofloxacin (inhalation use), Treatment of cystic fibrosis, 03/08/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Amphotericin B (for inhalation use), Prevention of pulmonary fungal infection in patients deemed at risk, 28/08/2006, Withdrawn

Orphan designation: Amphotericin B (for inhalation use), Prevention of pulmonary fungal infection in patients deemed at risk, 28/08/2006, Withdrawn

Orphan designation: Amphotericin B (for inhalation use), Prevention of pulmonary fungal infection in patients deemed at risk, 28/08/2006, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: azacitidine, Treatment of acute myeloid leukaemia, 29/11/2007, Expired

Orphan designation: azacitidine, Treatment of acute myeloid leukaemia, 29/11/2007, Expired

Orphan designation: azacitidine, Treatment of acute myeloid leukaemia, 29/11/2007, Expired

Europe - EMA - European Medicines Agency

20-2-2019


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

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

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

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Mannitolum, Treatment of cystic fibrosis, 07/11/2005, Positive

Orphan designation: Mannitolum, Treatment of cystic fibrosis, 07/11/2005, Positive

Orphan designation: Mannitolum, Treatment of cystic fibrosis, 07/11/2005, Positive

Europe - EMA - European Medicines Agency