EDISTON 200 mg, gélule

Information principale

  • Nom commercial:
  • EDISTON 200 mg, gélule
  • Dosage:
  • 200 mg
  • forme pharmaceutique:
  • gélule
  • Composition:
  • composition pour une gélule > nifuroxazide : 200 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) PVC-aluminium de 12 gélule(s)
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • EDISTON 200 mg, gélule
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • AUTRES ANTI-INFECTIEUX INTESTINAUX
  • Descriptif du produit:
  • 359 041-0 ou 4009 359 041 0 2 - plaquette(s) thermoformée(s) PVC-aluminium de 12 gélule(s) - Déclaration d'arrêt de commercialisation:25/01/2016;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Abrogée
  • Numéro d'autorisation:
  • 64887807
  • Date de l'autorisation:
  • 24-04-2002
  • Dernière mise à jour:
  • 18-12-2018

Notice: composition, indications thérapeutiques, interactions, posologie, effets indésirable, grossesse, allaitement

NOTICE

ANSM - Mis à jour le : 17/02/2003

Dénomination du médicament

EDISTON 200 mg, gélule

Encadré

Veuillez lire attentivement cette notice avant de prendre ce médicament. Elle contient des informations importantes

pour votre traitement.

Si vous avez d'autres questions, si vous avez un doute, demandez plus d'informations à votre médecin ou à votre

pharmacien.

Gardez cette notice, vous pourriez avoir besoin de la relire.

Si vous avez besoin de plus d'informations et de conseils, adressez-vous à votre pharmacien.

Si les symptômes s'aggravent ou persistent après 3 jours, consultez votre médecin.

Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si vous ressentez un des effets mentionnés

comme étant grave, veuillez en informer votre médecin ou votre pharmacien.

Sommaire notice

Dans cette notice :

1. QU'EST-CE QUE EDISTON 200 mg, gélule ET DANS QUELS CAS EST-IL UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE EDISTON 200 mg, gélule ?

3. COMMENT PRENDRE EDISTON 200 mg, gélule ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER EDISTON 200 mg, gélule ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE EDISTON 200 mg, gélule ET DANS QUELS CAS EST-IL UTILISE ?

Classe pharmacothérapeutique

Ce médicament est un antibactérien intestinal.

Indications thérapeutiques

Il est indiqué, chez l'adulte (à partir de 15 ans), dans le traitement de la diarrhée aiguë d'origine infectieuse.

Le traitement ne dispense pas de mesures diététiques et d'une réhydratation si elle est nécessaire.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE EDISTON 200 mg, gélule ?

Liste des informations nécessaires avant la prise du médicament

Sans objet.

Contre-indications

Ne prenez jamais EDISTON 200 mg, gélule en cas d'allergie aux dérivés du nitrofurane.

Précautions d'emploi ; mises en garde spéciales

Faites attention avec EDISTON 200 mg, gélule:

Vous devez consulter rapidement votre médecin dans les cas suivants:

en l'absence d'amélioration au bout de 3 jours de traitement,

en cas d'apparition de fièvre, de vomissement,

en cas de présence de sang ou de glaires dans les selles,

en cas de soif intense, de sensation de langue sèche. En effet, ces signes montrent un début de déshydratation, c'est-à-dire

de perte importante de liquide due à la diarrhée. Votre médecin jugera alors de la nécessité de prescrire une réhydratation

qui pourra se faire par voie orale ou par voie intraveineuse.

Ce traitement est un complément des règles diététiques:

se réhydrater par des boissons abondantes, salées ou sucrées, afin de compenser les pertes de liquide dues à la diarrhée

(la ration quotidienne moyenne en eau de l'adulte est de 2 litres);

s'alimenter le temps de la diarrhée,

en excluant certains apports et particulièrement les crudités, les fruits, les légumes verts, les plats épicés, ainsi que les

aliments ou boissons glacés,

en privilégiant les viandes grillées, le riz.

En raison de la présence de saccharose, ce médicament est contre-indiqué en cas d'intolérance au fructose, de syndrome

de malabsorption du glucose et du galactose ou de déficit en sucrase-isomaltase (maladies métaboliques rares).

Interactions avec d'autres médicaments

Prise ou utilisation d'autres médicaments

Si vous prenez ou avez pris récemment un autre médicament, y compris un médicament obtenu sans ordonnance, parlez-en

à votre médecin ou à votre pharmacien.

Interactions avec les aliments et les boissons

Sans objet.

Interactions avec les produits de phytothérapie ou thérapies alternatives

Sans objet.

Utilisation pendant la grossesse et l'allaitement

Grossesse et allaitement

Il est préférable de ne pas utiliser le nifuroxazide pendant la grossesse.

L'allaitement demeure possible en cas de traitement bref par ce médicament.

Demandez conseil à votre médecin ou à votre pharmacien avant de prendre tout médicament.

Sportifs

Sans objet.

Effets sur l'aptitude à conduire des véhicules ou à utiliser des machines

Sans objet.

Liste des excipients à effet notoire

Liste des excipients à effet notoire: saccharose.

3. COMMENT PRENDRE EDISTON 200 mg, gélule ?

Instructions pour un bon usage

Sans objet.

Posologie, Mode et/ou voie(s) d'administration, Fréquence d'administration et Durée du traitement

Posologie

RESERVE A L'ADULTE (à partir de 15 ans).

1 gélule, 4 fois par jour.

Mode d'administration

Avalez les gélules à l'aide d'un verre d'eau.

Si vous avez l'impression que l'effet de EDISTON 200 mg, gélule est trop fort ou trop faible, consultez votre médecin ou

votre pharmacien.

Voie orale.

Durée de traitement

La durée du traitement est limitée à 3 jours.

Symptômes et instructions en cas de surdosage

Si vous avez utilisé EDISTON 200 mg, gélule plus de fois que vous n'auriez dû: consultez immédiatement votre

médecin ou votre pharmacien.

Instructions en cas d'omission d'une ou de plusieurs doses

Si vous oubliez de prendre EDISTON 200 mg, gélule: ne prenez pas de dose double pour compenser la dose que vous

avez oublié de prendre

Risque de syndrome de sevrage

Sans objet.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Description des effets indésirables

Comme tous les médicaments, EDISTON 200 mg, gélule est susceptible d'avoir des effets indésirables, bien que tout le

monde n'y soit pas sujet.

Possibilité de réactions allergiques.

Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si certains effets indésirables deviennent

graves, veuillez en informer votre médecin ou votre pharmacien.

5. COMMENT CONSERVER EDISTON 200 mg, gélule ?

Tenir hors de la portée et de la vue des enfants.

Date de péremption

Ne pas utiliser EDISTON 200 mg, gélule après la date de péremption mentionnée sur la boîte.

Conditions de conservation

Pas de précautions particulières de conservation.

Si nécessaire, mises en garde contre certains signes visibles de détérioration

Les médicaments ne doivent pas être jetés au tout à l'égout ou avec les ordures ménagères. Demandez à votre pharmacien

ce qu'il faut faire des médicaments inutilisés. Ces mesures permettront de protéger l'environnement.

6. INFORMATIONS SUPPLEMENTAIRES

Liste complète des substances actives et des excipients

Que contient EDISTON 200 mg, gélule ?

La substance active est:

Nifuroxazide ................................................................................................................................ 200,00 mg

Pour une gélule.

Les autres composants sont:

amidon de maïs, saccharose, stéarate de magnésium.

Enveloppe de la gélule: gélatine, oxyde de fer jaune (E 172), dioxyde de titane (E 171).

Forme pharmaceutique et contenu

Qu'est-ce que EDISTON 200 mg, gélule et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de gélules. Boîte de 12.

Nom et adresse du titulaire de l'autorisation de mise sur le marché et du titulaire de l'autorisation de fabrication responsable

de la libération des lots, si différent

Titulaire

Pierre FABRE MEDICAMENT

45, place Abel Gance

92654 Boulogne Cedex

Exploitant

Laboratoires PIERRE FABRE MEDICAMENT

45, Place Abel Gance

92100- BOULOGNE

Fabricant

Laboratoires OPODEX-INDUSTRIE

34-46, avenue du Vieux Chemin de Saint-Denis

92392 VILLENEUVE-LA-GARENNE CEDEX

Noms du médicament dans les Etats membres de l'Espace Economique Européen

Sans objet.

Date d’approbation de la notice

La dernière date à laquelle cette notice a été approuvée est le {date}.

AMM sous circonstances exceptionnelles

Sans objet.

Informations Internet

Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Afssaps (France).

Informations réservées aux professionnels de santé

Sans objet.

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Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 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 propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor rappelle des contenants de 100 mg de liquide à vapoter sans saveur à base de nicotine

First Choice Vapor rappelle des contenants de 100 mg de liquide à vapoter sans saveur à base de nicotine

Ces produits de vapotage ne respectent pas les exigences du Règlement sur les produits chimiques et contenants de consommation 2001 (RPCCC, 2001) pris en vertu de la Loi canadienne sur la sécurité des produits de consommation.

Canadiens en santé

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Nature's Ultimate rappelle les produits NuWrench et NuStainless

Nature's Ultimate rappelle les produits NuWrench et NuStainless

Les produits rappelés ne sont pas vendus dans les contenants protège-enfants requis conformément au Règlement sur les produits chimiques et contenants de consommation 2001, pris en vertu de la Loi canadienne sur la sécurité des produits de consommation.

Canadiens en santé

7-11-2018

Murray Wholesale Cash & Carry rappelle des bouteilles de butane King

Murray Wholesale Cash & Carry rappelle des bouteilles de butane King

Les produits rappelés ne respectent pas les dispositions relatives aux mises en garde devant figurer sur l'étiquette du Règlement sur les produits chimiques et contenants de consommation 2001 pris en vertu de la Loi canadienne sur la sécurité des produits de consommation.

Canadiens en santé

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl 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 confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Vanpak Limitedrappelle le gaz butane extra purifié David Ross

Vanpak Limitedrappelle le gaz butane extra purifié David Ross

Les produits rappelés ne respectent pas les dispositions du Règlement sur les produits chimiques et contenants de consommation 2001 pris en vertu de la Loi canadienne sur la sécurité des produits de consommation relativement aux étiquettes de mise en garde. Un étiquetage incorrect pourrait entraîner une exposition non intentionnelle au produit et causer de graves maladies et blessures, voire la mort.

Canadiens en santé

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Rappel de noix de la marque Duyvis

Rappel de noix de la marque Duyvis

Les autorités de la sécurité alimentaire luxembourgeoises viennent d’être informées via le système d’alerte rapide des denrées alimentaires de la Commission Européenne du rappel du produit :« Duyvis Crac a Nut Paprika 200 grammes »qui a été distribué au Luxembourg dans

Ministère de la Santé - Luxembourg

25-10-2018

BLL Enterprises Inc. rappelle le produit protecteur en aérosol contre la rouille et la corrosion Fluid Film

BLL Enterprises Inc. rappelle le produit protecteur en aérosol contre la rouille et la corrosion Fluid Film

Les produits rappelés n'ont pas été étiquetés correctement conformément au Règlement sur les produits chimiques et contenants de consommation 2001 pris en vertu de la Loi canadienne sur la sécurité des produits de consommation.

Canadiens en santé

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

23-10-2018

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

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

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified 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, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

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)

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron 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, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 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 cyflufenamid. To assess the occurrence of cyflufenamid 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 (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

18-12-2018


Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Europe - EMA - European Medicines Agency

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration