ANASTROZOLE Chemical Farma

Information principale

  • Nom commercial:
  • ANASTROZOLE Chemical Farma 1 mg, comprimé pelliculé
  • Dosage:
  • 1 mg
  • forme pharmaceutique:
  • comprimé
  • Composition:
  • composition pour un comprimé > anastrozole : 1 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) PVC PVDC aluminium de 28 comprimé(s)
  • Type d'ordonnance:
  • liste I
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • ANASTROZOLE Chemical Farma 1 mg, comprimé pelliculé
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • Inhibiteurs enzymatiques
  • Descriptif du produit:
  • 393 316-9 ou 4009 393 316 9 0 - plaquette(s) thermoformée(s) PVC PVDC aluminium de 28 comprimé(s) - Déclaration de commercialisation non communiquée:;393 317-5 ou 4009 393 317 5 1 - plaquette(s) thermoformée(s) PVC PVDC aluminium de 30 comprimé(s) - Déclaration de commercialisation non communiquée:;393 318-1 ou 4009 393 318 1 2 - plaquette(s) thermoformée(s) PVC PVDC aluminium de 100 comprimé(s) - Déclaration de commercialisation non communiquée:;393 319-8 ou 4009 393 319 8 0 - flacon(s) polyéthylène haute densité (PEHD) de 28 comprimé(s) - Déclaration de commercialisation non communiquée:;393 320-6 ou 4009 393 320 6 2 - flacon(s) polyéthylène haute densité (PEHD) de 30 comprimé(s) - Déclaration de commercialisation non communiquée:;393 321-2 ou 4009 393 321 2 3 - flacon(s) polyéthylène haute densité (PEHD) 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:
  • 69965074
  • Date de l'autorisation:
  • 10-03-2009
  • Dernière mise à jour:
  • 09-08-2017

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

NOTICE

ANSM - Mis à jour le : 13/02/2013

Dénomination du médicament

ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé

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 ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé ET DANS QUELS CAS EST-IL

UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE ANASTROZOLE CHEMICAL FARMA 1

mg, comprimé pelliculé ?

3. COMMENT PRENDRE ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé ET DANS QUELS CAS EST-IL

UTILISE ?

Classe pharmacothérapeutique

ANASTROZOLE IB LABO contient une substance appelée anastrozole. Il appartient à un groupe de médicaments appelés «

inhibiteurs de l’aromatase ».

ANASTROZOLE IB LABO agit en diminuant la quantité d’une hormone appelée estrogène que votre corps fabrique. Il

effectue cela en bloquant une substance naturelle (un enzyme) de votre corps appelé « aromatase ».

Indications thérapeutiques

ANASTROZOLE IB LABO est utilisé dans le traitement du cancer du sein de la femme ménopausée.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE ANASTROZOLE CHEMICAL FARMA 1

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 ANASTROZOLE IB LABO 1 mg, comprimé pelliculé :

si vous êtes allergique (hypersensible) à l’anastrozole ou à l’un des autres composants contenus dans ANASTROZOLE IB

LABO (voir rubrique 6 pour plus d’informations).

si vous êtes enceinte ou si vous allaitez (voir la rubrique appelée « Grossesse et allaitement »).

Ne prenez pas ANASTROZOLE IB LABO si l’une des situations ci-dessus vous concerne. Si vous avez un doute, vérifiez avec votre médecin ou votre

pharmacien avant de prendre ANASTROZOLE IB LABO.

Précautions d'emploi ; mises en garde spéciales

Faites attention avec ANASTROZOLE IB LABO 1 mg, comprimé pelliculé :

Vérifiez avec votre médecin ou votre pharmacien avant de prendre ANASTROZOLE IB LABO :

si vous avez encore vos règles et si vous n’êtes pas encore ménopausée ;

si vous prenez un médicament qui contient du tamoxifène ou des médicaments qui contiennent un estrogène (voir rubrique

« Prise d’autres médicaments ») ;

si vous avez déjà présenté des conditions qui affectent la solidité de vos os (ostéoporose) ;

si vous avez des problèmes avec votre foie ou vos reins.

Si l’une des situations ci-dessus vous concerne, ou si vous avez un doute, vérifiez avec votre médecin ou votre pharmacien

avant de prendre ANASTROZOLE IB LABO.

Si vous êtes hospitalisé, informez le personnel de l’hôpital que vous prenez ANASTROZOLE IB LABO .

L’utilisation de ce médicament est déconseillée chez les patients présentant une intolérance au galactose,

un déficit en lactase de Lapp ou un syndrome de malabsorption du glucose ou du galactose (maladies

héréditaires rares).

Interactions avec d'autres médicaments

Prise 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. Cela comprend les médicaments achetés sans ordonnance ou les médicaments à

base de plantes. En effet, ANASTROZOLE IB LABO peut affecter la façon dont certains médicaments agissent, et certains

médicaments peuvent avoir un effet sur ANASTROZOLE IB LABO .

Ne prenez pas ANASTROZOLE IB LABO si vous prenez déjà un des médicaments suivants :

Certains médicaments utilisés dans le traitement du cancer du sein (modulateurs sélectifs des récepteurs aux estrogènes)

tels que les médicaments contenant du tamoxifène. Ces médicaments peuvent empêcher ANASTROZOLE IB LABO d’agir

correctement.

Un médicament à base d’estrogène, par exemple pour un traitement hormonal de substitution (THS).

Si vous prenez l'un de ces médicaments, demandez conseil à votre médecin ou à votre pharmacien.

Si vous prenez l’un des médicaments suivants, dites-le à votre médecin ou à votre pharmacien :

Un médicament appelé analogue de la LHRH (gonadoréline, buséréline, goséréline, leuproréline et triptoréline). Ces

médicaments sont utilisés pour le traitement du cancer du sein, certaines maladies (gynécologiques) de la femme et la

stérilité.

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 - Allaitement

ANASTROZOLE IB LABO ne doit pas être utilisé en cas de grossesse ou d’allaitement. Arrêtez ANASTROZOLE IB LABO

en cas de survenue d’une grossesse et parlez-en à votre médecin.

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

Conduite de véhicules et utilisation de machines

ANASTROZOLE IB LABO ne devrait pas affecter votre aptitude à conduire des véhicules et à utiliser des outils ou des

machines. Cependant certaines personnes peuvent occasionnellement ressentir une faiblesse ou une somnolence lors de

leur traitement par ANASTROZOLE IB LABO. Dans ce cas, demandez conseil à votre médecin ou à votre pharmacien.

Liste des excipients à effet notoire

Informations importantes concernant certains composants d’ANASTROZOLE IB LABO 1 mg, comprimé pelliculé :

ANASTROZOLE IB LABO contient du lactose, qui est un sucre. Si votre médecin vous a informé(e) d'une intolérance à

certains sucres, contactez-le avant de prendre ce médicament.

3. COMMENT PRENDRE ANASTROZOLE CHEMICAL FARMA 1 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.

La dose habituelle est de un comprimé par jour.

Essayez de prendre le comprimé chaque jour au même moment.

Avalez le comprimé entier avec un verre d’eau.

Vous pouvez prendre le comprimé avec ou sans aliments.

Continuez de prendre ANASTROZOLE IB LABO aussi longtemps que votre médecin vous le dit. C’est un traitement de

longue durée et vous pouvez avoir besoin de le prendre pendant plusieurs années.

Utilisation chez les enfants

ANASTROZOLE IB LABO ne doit pas être donné aux enfants et aux adolescents.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus d'ANASTROZOLE IB LABO 1 mg, comprimé pelliculé que vous n'auriez dû :

Si vous avez pris plus d’ANASTROZOLE IB LABO que vous n’auriez dû, avertissez aussitôt votre médecin.

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

Si vous oubliez de prendre ANASTROZOLE IB LABO 1 mg, comprimé pelliculé :

Si vous oubliez de prendre une dose, prenez juste la dose suivante au moment habituel.

Ne prenez pas de dose double (deux doses en même temps) pour compenser la dose que vous avez oublié de prendre.

Risque de syndrome de sevrage

Si vous arrêtez de prendre ANASTROZOLE IB LABO 1 mg, comprimé pelliculé :

N’arrêtez pas de prendre vos comprimés sauf si votre médecin vous le dit.

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, ANASTROZOLE IB LABO peut provoquer des effets indésirables, mais ils ne surviennent

pas systématiquement chez tout le monde.

Effets indésirables très fréquents (chez plus de 1 patiente sur 10)

Mal de tête.

Bouffées de chaleur.

Nausée (envie de vomir).

Eruption cutanée.

Douleur ou raideur articulaire.

Inflammation des articulations (arthrite).

Sensation de faiblesse.

Perte osseuse (ostéoporose)

Effets indésirables fréquents (chez 1 à 10 patientes sur 100)

Perte d’appétit.

Taux augmenté ou élevé dans le sang d’une substance grasse appelée cholestérol. Cette augmentation pourrait être

constatée par une analyse de sang.

Somnolence.

Syndrome du canal carpien (picotements, douleur, refroidissement, faiblesse dans certaines parties de la main).

Diarrhée.

Vomissement.

Changement dans les résultats des tests sanguins qui renseignent sur le fonctionnement de votre foie.

Perte des cheveux.

Réactions allergiques (hypersensibilité) incluant le visage, les lèvres ou la langue.

Douleur osseuse.

Sécheresse vaginale.

Saignement vaginal (en général lors des toutes premières semaines de traitement - si les saignements persistent, parlez en

à votre médecin).

Effets indésirables peu fréquents (chez 1 à 10 patientes sur 1 000)

Changement dans les résultats de tests sanguins spécifiques qui renseignent sur le fonctionnement de votre foie (gamma-

GT et bilirubine).

Inflammation du foie (hépatite).

Urticaire.

Doigt à ressort (un état où l’un de vos doigts ou le pouce se bloque dans une position fléchie).

Effets indésirables rares (chez 1 à 10 patientes sur 10 000)

Inflammation rare de la peau qui peut inclure des plaques rouges ou des cloques.

Eruptions

cutanées

causées

hypersensibilité

(ceci

peut

être

causé

réactions

allergiques

anaphylactoïdes).

Inflammation des petits vaisseaux sanguins provoquant une coloration rouge ou violette de la peau. Très rarement des

troubles articulaires, des douleurs au niveau de l’estomac et des reins peuvent apparaître, connus sous le nom de « purpura

d’Henoch-Schönlein ».

Effets indésirables très rares (chez moins d’1 patiente sur 10 000)

Une réaction extrêmement sévère de la peau avec ulcères ou cloques. Cette réaction s’appelle « syndrome de Stevens-

Johnson ».

Réactions allergiques (hypersensibilité) avec un gonflement de la gorge qui peut entraîner une difficulté à avaler ou à

respirer. Cette réaction s’appelle « angioedème ».

Si vous ressentez ces troubles, appelez une ambulance ou consultez immédiatement un médecin car un traitement

d’urgence peut être nécessaire.

Effets sur les os

ANASTROZOLE IB LABO agit en réduisant la quantité de l’hormone appelée estrogène présente dans votre organisme. Cet

effet peut diminuer le contenu minéral de vos os. Vos os peuvent devenir moins résistants et plus sensibles aux fractures.

Votre médecin prendra en charge ces risques conformément aux recommandations sur les traitements pour le maintien de la

santé osseuse chez les femmes ménopausées. Vous devez discuter avec votre médecin sur les risques et les options de

traitement.

Si vous ressentez un des effets indésirables mentionnés comme grave ou si vous présentez des effets indésirables non

mentionnés dans cette notice, veuillez en informer votre médecin ou votre pharmacien.

5. COMMENT CONSERVER ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé ?

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

Date de péremption

Ne pas utiliser ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé après la date de péremption mentionnée sur

la boîte.

Conditions de conservation

Pas de précautions particulières.

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 ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé ?

La substance active est:

Anastrozole ......................................................................................................................................... 1 mg

Pour un comprimé pelliculé.

Les autres composants sont:

Lactose monohydraté, povidone K30, carboxyméthylamidon sodique, stéarate de magnésium.

Pelliculage: OPADRY BLANC Y-1-7000*

* hypromellose, macrogol 400, dioxyde de titane.

Forme pharmaceutique et contenu

Qu'est-ce que ANASTROZOLE CHEMICAL FARMA 1 mg, comprimé pelliculé et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de comprimé pelliculé. Boîte de 28, 30, ou 100 comprimés.

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

chemical farma

3 quai louis bleriot

75016 paris

Exploitant

chemical farma

3 quai louis bleriot

75016 paris

Fabricant

ZEPPENFELDT PHARMA GMBH

WEILERSTRASSE 19-21

D-79540 LORRACH

ALLEMAGNE

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’Ansm (France).

Informations réservées aux professionnels de santé

Sans objet.

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

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

Health Canada

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

20-9-2018

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNP

Canadians should not buy or use health products that contain 2,4-dinitrophenol, more commonly known as DNP, because it is toxic and can cause death. Products containing DNP are primarily marketed towards bodybuilders and are promoted online as a "fat burner" or "shredder" and for weight loss.

Health Canada

14-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Food chemical occurrence data: nominations open for stakeholder group

Food chemical occurrence data: nominations open for stakeholder group

Food chemical occurrence data: nominations open for stakeholder group

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

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

Health Canada

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

14-8-2018

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing 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. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

20-7-2018

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Health Canada's inspection program found the recalled product does not meet the labelling and child-resistant packaging requirements for consumer chemical products as set out in the Consumer Chemicals and Containers Regulations, 2001.

Health Canada

20-7-2018

J2Labz recalls Sugar Shack Vaping Liquid

J2Labz recalls Sugar Shack Vaping Liquid

Health Canada's sampling and evaluation program has determined that these vaping products do not meet the packaging and labelling requirements of the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

19-7-2018

Assessment of the safety of feminine hygiene products

Assessment of the safety of feminine hygiene products

Today ANSES is publishing its health risk assessment on the safety of feminine hygiene products. Chemicals have been identified in these products at very low concentrations not exceeding health thresholds. The expert appraisal did not reveal any risk associated with these substances. Nevertheless, the Agency recommends that manufacturers improve the quality of these products in order to eliminate or minimise the presence of chemicals. ANSES’s expert appraisal also examined the risk of menstrual toxic sho...

France - Agence Nationale du Médicament Vétérinaire

19-7-2018

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

11-7-2018

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

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

Health Canada

4-7-2018

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Cases of skin allergies and irritation related to clothing or footwear are regularly reported to the health authorities. Today ANSES is publishing the results of the expert appraisal it conducted to identify the chemicals likely to be found in these articles and possibly responsible for these cases. Further to this expert appraisal, the Agency is issuing recommendations on how to better protect consumers from the risks of skin allergies and irritation caused by the presence of these substances.

France - Agence Nationale du Médicament Vétérinaire

25-6-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

FDA Commissioner Scott Gottlieb, M.D., discusses the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components.

FDA - U.S. Food and Drug Administration

30-5-2018

Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

In 2016, as part of the implementation of the Act "for the restoration of biodiversity, nature and landscapes” and as requested by the Ministries of Agriculture, Health and Ecology, ANSES initiated an assessment weighing up the risks and benefits of plant protection products containing neonicotinoids, compared with their chemical and non-chemical alternatives. Today, ANSES is publishing its final opinion. For most uses of plant protection products containing neonicotinoids, sufficiently effective and ope...

France - Agence Nationale du Médicament Vétérinaire

17-5-2018

Alumilite recalls Amazing Clear Cast

Alumilite recalls Amazing Clear Cast

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

Health Canada

28-11-2018

Final decisions amending, or not amending, the current Poisons Standard, November 2018

Final decisions amending, or not amending, the current Poisons Standard, November 2018

Final decisions and reasons for medicines and chemicals referred to the June 2018 scheduling meetings

Therapeutic Goods Administration - Australia

23-8-2018

Final decisions amending, or not amending, the current Poisons Standard, August 2018

Final decisions amending, or not amending, the current Poisons Standard, August 2018

Final decisions for matters referred to the March 2018 ACMS/ACCS meetings & delegate-only decisions on agricultural chemicals & NCEs

Therapeutic Goods Administration - Australia

15-8-2018

Scientific guideline:  Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

This document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances.

Europe - EMA - European Medicines Agency

4-6-2018

Prescription medicines: registration of new chemical entities in Australia

Prescription medicines: registration of new chemical entities in Australia

3 medicines added

Therapeutic Goods Administration - Australia