SIMVASTATINE Accord Healthcare

Information principale

  • Nom commercial:
  • SIMVASTATINE Accord Healthcare 80 mg, comprimé pelliculé
  • Dosage:
  • 80 mg
  • forme pharmaceutique:
  • comprimé
  • Composition:
  • composition pour un comprimé > simvastatine : 80 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 10 comprimé(s)
  • Type d'ordonnance:
  • liste I
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • SIMVASTATINE Accord Healthcare 80 mg, comprimé pelliculé
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • Groupe Inhibiteur de l'HMG-CoA réductase
  • Descriptif du produit:
  • 388 673-1 ou 4009 388 673 1 2 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 10 comprimé(s) - Déclaration de commercialisation non communiquée:;388 674-8 ou 4009 388 674 8 0 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 14 comprimé(s) - Déclaration de commercialisation non communiquée:;388 675-4 ou 4009 388 675 4 1 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 28 comprimé(s) - Déclaration de commercialisation non communiquée:;388 677-7 ou 4009 388 677 7 0 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 50 comprimé(s) - Déclaration de commercialisation non communiquée:;388 678-3 ou 4009 388 678 3 1 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 30 comprimé(s) - Déclaration de commercialisation non communiquée:;388 680-8 ou 4009 388 680 8 1 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 56 comprimé(s) - Déclaration de commercialisation non communiquée:;388 681-4 ou 4009 388 681 4 2 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 84 comprimé(s) - Déclaration de commercialisation non communiquée:;573 699-3 ou 4009 573 699 3 4 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 98 comprimé(s) - Déclaration de commercialisation non communiquée:;573 700-1 ou 4009 573 700 1 5 - plaquette(s) thermoformée(s) PVC polyéthylène PVDC aluminium de 100 comprimé(s) - Déclaration de commercialisation non communiquée:;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Archivée
  • Numéro d'autorisation:
  • 66603547
  • Date de l'autorisation:
  • 24-09-2008
  • Dernière mise à jour:
  • 11-08-2017

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

NOTICE

ANSM - Mis à jour le : 02/10/2012

Dénomination du médicament

SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé

Simvastatine.

Encadré

Veuillez lire attentivement l'intégralité de cette notice avant de prendre ce médicament.

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

Si vous avez toute autre question, si vous avez un doute, demandez plus d'informations à votre médecin ou à votre

pharmacien.

Ce médicament vous a été personnellement prescrit. Ne le donnez jamais à quelqu'un d'autre, même en cas de symptômes

identiques, cela pourrait lui être nocif.

Si l'un des effets indésirables devient grave ou si vous remarquez un effet indésirable non mentionné dans cette notice,

parlez-en à votre médecin ou à votre pharmacien.

Sommaire notice

Dans cette notice :

1. QU'EST-CE QUE SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé ET DANS QUELS CAS EST-IL

UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE SIMVASTATINE ACCORD

HEALTHCARE 80 mg, comprimé pelliculé ?

3. COMMENT PRENDRE SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé ET DANS QUELS CAS EST-IL

UTILISE ?

Classe pharmacothérapeutique

SIMVASTATINE ACCORD HEALTHCARE est un médicament utilisé pour faire baisser les taux du cholestérol total, du

mauvais cholestérol (cholestérol LDL), et des substances grasses appelées triglycérides dans le sang.

De plus, SIMVASTATINE ACCORD HEALTHCARE augmente les niveaux du bon cholestérol (cholestérol HDL). Vous

devez poursuivre un régime hypocholestérolémiant pendant la prise de ce médicament.

Indications thérapeutiques

SIMVASTATINE ACCORD HEALTHCARE est utilisé dans le cadre d'un régime, si vous avez:

un taux élevé de cholestérol dans votre sang (hypercholestérolémie primaire) ou des niveaux élevés de graisse dans votre

sang (dyslipidémie mixte),

une maladie héréditaire (hypercholestérolémie familiale homozygote) qui augmente le taux de cholestérol dans le sang.

Vous pouvez également recevoir d'autres traitements,

une insuffisance coronarienne ou un risque élevé d'insuffisance coronarienne (parce que vous avez un diabète, avez un

antécédent d'accident vasculaire cérébral ou une maladie vasculaire d'origine athéroscléreuse). SIMVASTATINE ACCORD

HEALTHCARE peut prolonger votre vie en réduisant le risque de problèmes cardiaques, indépendamment de la quantité de

votre cholestérol sanguin.

Chez la plupart des gens, il n'y a pas de symptôme immédiat du à un taux élevé de cholestérol. Votre médecin peut mesurer

votre cholestérol à l'aide d'un simple test sanguin. Consultez votre médecin régulièrement, vérifiez votre cholestérol, et

discutez avec votre médecin des résultats à atteindre.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE SIMVASTATINE ACCORD

HEALTHCARE 80 mg, comprimé pelliculé ?

Liste des informations nécessaires avant la prise du médicament

Si votre médecin vous a informé (e) d'une intolérance à certains sucres, contactez-le avant de prendre ce médicament.

Contre-indications

Ne prenez jamais SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé:

si vous êtes allergique (hypersensible) à la simvastatine ou à l'un des autres composants contenus dans SIMVASTATINE

ACCORD HEALTHCARE,

si vous avez actuellement des problèmes hépatiques,

si vous êtes enceinte ou allaitez,

si vous prenez:

de l'itraconazole ou du kétoconazole (médicaments traitant certaines infections à champignons),

de l'érythromycine, de la clarithromycine ou de la télithromycine (antibiotiques),

des antiprotéases (Voir la rubrique « utiliser d'autres médicaments »),

de la néfazodone (antidépresseur).

Précautions d'emploi ; mises en garde spéciales

Faites attention avec SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé:

si vous avez des problèmes rénaux

si vous avez des problèmes de thyroïde non contrôlés (hypothyroïdie)

si vous souffrez ou avez souffert de sensibilité, de faiblesse ou de douleur musculaire lors de l'utilisation d'une statine

(famille de médicament hypocholestérolémiant) ou lors de l'utilisation de fibrates (médicaments également hypolipémiant)

si vous ou votre famille proche souffrez de troubles musculaires héréditaires ou si vous présentez des antécédents de

problèmes musculaires

si vous consommez ou avez consommez une grande quantité d'alcool

prévenez votre médecin si vous devez être opéré. Il pourrait s'avérer nécessaire d'arrêter de prendre les comprimés

SIMVASTATINE ACCORD HEALTHCARE pendant une courte durée.

si vous avez déjà eu des troubles hépatiques

si vous avez plus de 70 ans

Votre médecin peut également vous prescrire des tests sanguins afin de vérifier votre fonction hépatique avant et pendant

votre traitement par simvastatine.

La dose de 80 mg est uniquement recommandée pour des patients avec un taux de cholestérol très élevé dans le sang

(hypercholestérolémie) et avec un risque important de complications cardiovasculaires.

Si vous présentez des douleurs musculaires inexpliquées, une hypersensibilité, une faiblesse ou des crampes

musculaires, consultez immédiatement votre médecin.

L'utilisation de la simvastatine peut donner lieu, quoique rarement, à une dégénérescence des tissus musculaires

(rhabdomyolyse) accompagnée de douleur, de sensibilité, de faiblesse ou de crampes musculaires, de fièvre et de

coloration brun rougeâtre des urines (voir la rubrique: « Effets secondaires éventuels »). Le risque d'apparition de problèmes

musculaires peut être augmenté par l'utilisation simultanée d'autres médicaments (voir la rubrique: « Utilisation d'autres

médicaments »).

Informez votre médecin si l'un des éléments cités ci-dessus vous concerne ou vous a concerné par le passé.

Ce médicament contient du lactose. Son utilisation est déconseillée chez les patients présentant une intolérance au lactose

(maladie héréditaire rare).

Interactions avec d'autres médicaments

Prise ou utilisation d'autres médicaments

Il est particulièrement important d'informer votre médecin si vous prenez l'un des médicaments suivants. Le fait de combiner

SIMVASTATINE ACCORD HEALTHCARE avec l'un de ces médicaments peut augmenter le risque d'apparition de

problèmes musculaires (dont certains ont déjà été énumérés à la rubrique précédente « Ne pas utiliser SIMVASTATINE

ACCORD HEALTHCARE »).

la ciclosporine (médicament fréquemment utilisé chez les patients ayant bénéficié d'une transplantation d'organes)

le danazol (traitement antihormonal utilisé dans le traitement du développement de la muqueuse utérine en dehors de

l'utérus (endométriose) et le traitement des seins douloureux et sensibles)

un médicament tel que l'itraconazole or le kétoconazole (médicaments préconisés dans le cas d'infections fongiques)

les fibrates tels que le gemfibrozil et le bézafibrate (médicaments utilisés pour baisser le taux de cholestérol)

l'érythromycine, la clarithromycine, la télithromycine ou l'acide fusidique (médicaments pour traiter les infections

bactériennes)

des inhibiteurs de la protéase du VIH tels que l'indinavir, le nelfinavir, le ritonavir et le saquinavir (médicaments préconisés

dans le traitement contre le sida)

la néfazodone (médicament contre la dépression)

l'amiodarone (médicament utilisé en cas de rythme cardiaque irrégulier)

le vérapamil ou le diltiazem (médicaments préconisés en cas de tension artérielle élevée, de douleurs dans la poitrine

associées à une maladie cardiaque ou autres troubles cardiaques)

De même que pour les médicaments listés ci-dessus, informez votre médecin ou votre pharmacien, si vous prenez ou avez

pris un autre médicament obtenu sans ordonnance. Prévenez notamment votre médecin si vous prenez l'un des

médicaments suivants:

médicaments servant à prévenir la formation de caillots sanguins, tels que la warfarine, la phenprocoumone ou

l'acénocoumarol (anticoagulants)

le fénofibrate (un médicament qui baisse le cholestérol).

des quantités importantes (au moins 1 g par jour) de niacine ou d'acide nicotinique (médicaments hypolipémiant).

Interactions avec les aliments et les boissons

Aliments et boissons

Le jus de pamplemousse contient un ou plusieurs composants qui modifient la transformation de certains médicaments,

notamment de SIMVASTATINE ACCORD HEALTHCARE. La consommation de jus de pamplemousse doit donc être

évitée.

Interactions avec les produits de phytothérapie ou thérapies alternatives

Sans objet.

Utilisation pendant la grossesse et l'allaitement

Grossesse et allaitement

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

Ne prenez pas SIMVASTATINE ACCORD HEALTHCARE si vous êtes enceinte, désirez le devenir ou si vous pensez être

enceinte. Si vous découvrez que vous êtes enceinte alors que vous prenez SIMVASTATINE ACCORD HEALTHCARE,

veuillez arrêter immédiatement de prendre ce médicament et prévenez votre médecin.

Ne prenez pas SIMVASTATINE ACCORD HEALTHCARE si vous allaitez en raison de l'absence de données quant au

passage de ce médicament dans le lait maternel.

Sportifs

Sans objet.

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

Conduite de véhicules et utilisation de machines

SIMVASTATINE ACCORD HEALTHCARE n'a en principe aucun effet sur votre aptitude à conduire des véhicules et à

utiliser des machines. Toutefois, en cas de conduite de véhicules et d'utilisation des machines, il convient de garder à l'esprit

que des cas de vertiges ont été signalés, quoique rarement.

Liste des excipients à effet notoire

Informations importantes concernant certains composants de SIMVASTATINE ACCORD HEALTHCARE 80 mg,

comprimé pelliculé

SIMVASTATINE ACCORD HEALTHCARE contient du lactose monohydraté (glucide du lait). Si selon votre médecin vous

présentez une intolérance à certains sucres, prévenez votre médecin avant de prendre ce médicament.

3. COMMENT PRENDRE SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé ?

Instructions pour un bon usage

Sans objet.

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

Respectez toujours la posologie indiquée par votre médecin. En cas de doute, consultez votre médecin ou votre

pharmacien.

Mode d'administration

Les comprimés SIMVASTATINE ACCORD HEALTHCARE doivent être pris avec un verre d'eau. Il peut être pris au moment

ou en dehors des repas.

Posologie

La posologie varie de 5 mg à 80 mg de simvastatine une fois par jour, à prendre le soir. Votre médecin pourra adapter votre

posologie après au moins 4 semaines de traitement sans toutefois dépasser une dose unique maximum de 80 mg par jour à

prendre le soir. La posologie de 80 mg n'est recommandée que pour les patients ayant un taux de cholestérol très élevé

(hypercholestérolémie) et présentant un risque élevé de complications cardiovasculaires.

Posologie pour les taux de cholestérol élevés dans le sang (hypercholestérolémie):

Vous devez suivre un régime hypocholestérolémiant avant de commencer le traitement et poursuivre ce régime durant toute

la durée du traitement par simvastatine.

La dose journalière habituelle de départ est de 10 mg ou 20 mg de simvastatine à prendre le soir. Si le taux de cholestérol

doit être fortement réduit, votre médecin pourra prescrire une posologie journalière initiale de 20 mg ou de 40 mg à prendre

le soir.

Si nécessaire, votre médecin adaptera la posologie selon les modalités indiquées à la rubrique « Posologie ».

Posologie en cas d'hypercholestérolémie familiale homozygote (taux de cholestérol élevé héréditaire dans le sang):

La posologie recommandée est de 40 mg par jour à prendre le soir, ou de 80 mg par jour (à prendre en trois doses de 20 mg,

20 mg et 40 mg le soir). Les comprimés SIMVASTATINE ACCORD HEALTHCARE doivent être utilisés en complément de

tout autre traitement hypolipémiant (par ex. aphérèse des LDL) ou, si ces traitements complémentaires ne sont pas

disponibles.

Posologie dans le cadre de la prévention de maladies cardiovasculaires:

La posologie journalière habituelle est de 20 mg ou de 40 mg à prendre le soir pour des patients présentant un risque élevé

de maladie coronarienne (en présence ou non d'un taux élevé de lipides dans le sang). Le traitement peut être débuté dans

le cadre d'un régime et d'exercices. Si nécessaire, votre médecin adaptera la posologie selon les modalités indiquées à la

rubrique « Posologie ».

Posologie en cas de thérapie en association avec d'autres médicaments:

Si SIMVASTATINE ACCORD HEALTHCARE est administrée en association avec d'autres médicaments (par ex. à base de

colestipol et de colestyramine) en vue de réduire le taux de cholestérol, elle doit être prise deux heures avant ou quatre

heures après la prise de ces médicaments.

Si vous prenez de la ciclosporine (médicament immunosuppresseurs) ou certains autres médicaments

hypocholestérolémiant (tels que le gemfibrozil, autres fibrates (à l'exception du fénofibrate)) ou de la niacine (en doses de

plus de 1 g par jour) en même temps que la simvastatine, la dose de simvastatine ne devra pas dépasser 10 mg par jour. Si

vous prenez de l'amiodarone ou du vérapamil (médicaments préconisés dans le traitement des troubles cardiaques) en

même temps que la simvastatine, la dose de simvastatine ne devra pas dépasser 20 mg par jour (voir la rubrique: «

Précautions particulières lors du traitement par SIMVASTATINE ACCORD HEALTHCARE »).

Posologie en cas d'insuffisance rénale:

Si votre fonction rénale est gravement altérée, votre médecin pourra vous prescrire une dose initiale plus faible.

Posologie pour les enfants de moins de 18 ans:

L'utilisation de la simvastatine n'est pas recommandée pour les enfants, le bénéfice/risque n'ayant pas été établi.

Posologie pour les patients âgés:

Aucun ajustement de la posologie n'est nécessaire.

Durée du traitement

Vous devrez prendre la simvastatine pendant une durée assez longue. Votre médecin vous informera de la durée du

traitement.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé que vous n'auriez dû:

Si vous avez utilisé ou pris trop de SIMVASTATINE ACCORD HEALTHCARE, contactez immédiatement votre médecin ou

votre pharmacien, ou l'hôpital le plus proche de chez vous.

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

Si vous oubliez de prendre SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé:

Si vous avez oublié de prendre SIMVASTATINE ACCORD HEALTHCARE, continuez simplement à prendre votre dose

habituelle le jour suivant. Ne prenez pas de dose double pour compenser la dose que vous avez oublié de prendre.

Continuez simplement le traitement habituel le jour suivant.

Risque de syndrome de sevrage

Si vous arrêtez de prendre SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé:

Continuez à prendre SIMVASTATINE ACCORD HEALTHCARE, sauf indication contraire de votre médecin. Si vous arrêtez

de prendre SIMVASTATINE ACCORD HEALTHCARE, votre taux de cholestérol risque d'augmenter à nouveau.

Si vous avez d'autres questions sur l'utilisation de ce médicament, demandez plus d'informations à votre médecin ou à votre

pharmacien.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Description des effets indésirables

Comme tous les médicaments, SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé est susceptible

d'avoir des effets indésirables, bien que tout le monde n'y soit pas sujet.

Le terme suivant est utilisé pour décrire la fréquence à laquelle les effets indésirables ont été rapportés:

Rare: survenant chez au moins 1 patient sur 10 000 et chez moins d'1 patient sur 1 000 traités

Très rare: chez au moins un patient sur 10 000 traités

Les effets graves suivants ont été rapportés, quoique rarement.

Si vous êtes concerné par l'un de ces effets graves, arrêtez de prendre le médicament et consultez votre médecin

immédiatement ou rendez-vous aux urgences de l'hôpital le plus proche.

douleur, sensibilité, faiblesse ou crampes musculaires. Dans de rares occasions, ces effets peuvent être sérieux et

notamment entraîner une dégénérescence musculaire responsable d'un dysfonctionnement rénal. Très peu de cas de décès

sont survenus.

réactions d'hypersensibilité (allergie) incluant:

gonflement du visage, de la langue et de la gorge pouvant entraîner des difficultés respiratoires

douleur musculaire grave, généralement au niveau des épaules et des hanches

éruption cutanée accompagnée d'une faiblesse des membres et des muscles du cou.

douleur ou inflammation des articulations

inflammation des vaisseaux sanguins

ecchymoses anormales, éruptions cutanées et gonflement, urticaire, sensibilité de la peau au soleil, fièvre, rougeurs

essoufflement et sentiment de malaise

maladies apparentées au lupus (y compris éruptions cutanées, troubles articulaires et effets sur les globules rouges)

troubles du foie accompagnés d'un jaunissement de la peau et des yeux, démangeaisons, urines foncées ou selles

décolorées, insuffisance hépatique (très rare)

inflammation du pancréas accompagnée d'une forte douleur abdominale.

Les effets indésirables suivants ont également été rapportés, quoique rarement:

diminution du nombre des globules rouges (anémie)

engourdissement ou faiblesse des bras et des jambes

maux de tête, sensation de fourmillements, étourdissements

troubles digestifs (douleur abdominale, constipation, flatulence, indigestion, diarrhée, nausée, vomissements)

éruptions, démangeaisons, chute de cheveux

faiblesse.

Tests biologiques

L'augmentation dans certains tests sanguins de laboratoire, de la fonction hépatique et d'une enzyme musculaire (créatine

kinase) a pu être observée.

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 SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé ?

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

Date de péremption

Ne pas utiliser SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé après la date de péremption

mentionnée sur la boîte. La date d'expiration fait référence au dernier jour du mois.

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 SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé ?

La substance active est:

Simvastatine ...................................................................................................................................... 80 mg

Pour un comprimé pelliculé.

Les autres composants sont:

Noyau: buthylhydroxyanisol (E 320), acide ascorbique (E 300), acide citrique monohydraté (E 330), cellulose,

microcristalline (E 460a), amidon de maïs prégélatinisé, lactose monohydraté, stéarate de magnésium (E 470B).

Pelliculage: hypromellose, hydroxypropylcellulose (E 464), dioxyde de titane (E 171), talc (E 553b), oxyde de fer rouge (E

172).

Forme pharmaceutique et contenu

Qu'est-ce que SIMVASTATINE ACCORD HEALTHCARE 80 mg, comprimé pelliculé et contenu de l'emballage

extérieur ?

Comprimé pelliculé.

Comprimés pelliculés rose, ronds, biconvexes et portant l'inscription « CV » sur une face.

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

ACCORD HEALTHCARE LIMITED

SAGE HOUSE

319 PINNER ROAD - NORTH HARROW

HA1 4HF MIDDLESEX

ROYAUME-UNI

Exploitant

ACCORD HEALTHCARE LIMITED

SAGE HOUSE

319 PINNER ROAD - NORTH HARROW

HA1 4HF MIDDLESEX

ROYAUME-UNI

Fabricant

ACCORD HEALTHCARE LIMITED

SAGE HOUSE

319, PINNER ROAD

NORTH HA1 4HF

ROYAUME-UNI

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

Ce médicament est autorisé dans les Etats membres de l'Espace Economique Européen sous les noms suivants:

Conformément à la réglementation en vigueur.

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.

Autres

Sans objet.

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27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

26-11-2018

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap.

FDA - U.S. Food and Drug Administration

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

Hazard identification and ranking for poultry at slaughter

Hazard identification and ranking for poultry at slaughter

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

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 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

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

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

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

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

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

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

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

22-10-2018

La ministre de la Santé donne son accord pour une nouvelle infrastructure hospitalière de rééducation gériatrique à l'Hôpital Intercommunal de Steinfort

La ministre de la Santé donne son accord pour une nouvelle infrastructure hospitalière de rééducation gériatrique à l'Hôpital Intercommunal de Steinfort

Tenant compte du vieillissement de la population et des besoins spécifiques des personnes âgées, le ministère de la Santé attache une grande importance à la rééducation des patients nécessitant un traitement spécifique, entre autres après une intervention chirurgicale ou un accident

Ministère de la Santé - Luxembourg

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

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

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

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

Présentation du Plan cadre national "Gesond iessen, Méi bewegen" 2018-2025

Présentation du Plan cadre national "Gesond iessen, Méi bewegen" 2018-2025

Suite à l’accord du Conseil de gouvernement, en juillet 2018, pour le renouvellement de la stratégie "Gesond iessen, Méi bewegen" (GIMB) dans un plan cadre national GIMB couvrant la période de 2018-2025, les ministres Lydia Mutsch, Romain Schneider, Claude Meisch et

Ministère de la Santé - Luxembourg

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 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 tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 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 the first 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 Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by 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

21-9-2018

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

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

Published on: Thu, 20 Sep 2018 00:00:00 +0200 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 State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

Published on: Wed, 12 Sep 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 fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 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 milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 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 napropamide. To assess the occurrence of napropamide 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 (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 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 fenbuconazole. To assess the occurrence of fenbuconazole 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...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 Aug 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 sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 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 prochloraz. To assess the occurrence of prochloraz 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 th...

Europe - EFSA - European Food Safety Authority Publications

26-11-2018

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cyber

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cyber

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cybersecurity threats.

FDA - U.S. Food and Drug Administration

22-11-2018

Rapiscan (GE Healthcare AS)

Rapiscan (GE Healthcare AS)

Rapiscan (Active substance: regadenoson) - Centralised - Yearly update - Commission Decision (2018)7875 of Thu, 22 Nov 2018

Europe -DG Health and Food Safety

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

2-10-2018

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6480 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Trizivir (ViiV Healthcare BV)

Trizivir (ViiV Healthcare BV)

Trizivir (Active substance: abacavir, lamivudine, zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6483 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/338/T/108

Europe -DG Health and Food Safety

2-10-2018

Telzir (ViiV Healthcare BV)

Telzir (ViiV Healthcare BV)

Telzir (Active substance: Fosamprenavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6468 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/534/T/93

Europe -DG Health and Food Safety

2-10-2018

Celsentri (ViiV Healthcare BV)

Celsentri (ViiV Healthcare BV)

Celsentri (Active substance: maraviroc) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6467 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/811/T/56

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments:  https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX  pic.twitter.com/iQsKIAAQTn

FDA - U.S. Food and Drug Administration

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

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

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

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

Europe - EMA - European Medicines Agency

17-9-2018

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

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

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

Europe - EMA - European Medicines Agency

7-9-2018

Newsletter:  Human medicines highlights - September 2018

Newsletter: Human medicines highlights - September 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency