FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of these areas that will influence the Agency's resource distribution in 2010 include complex interactions between the six scientific committees of the Agency, increases in post-authorisation, referral, safety-of-medicines-related activities, and provision of information.
French: Alcuni di questi ambiti che influenzeranno la distribuzione delle risorse dell'Agenzia nel 2010 includono complesse interazioni tra i sei comitati scientifici dell'Agenzia, incrementi nell'ambito della post-autorizzazione, del deferimento, delle attività correlate alla sicurezza dei medicinali e la fornitura di informazioni.
English: The global nature of drug development and research, coupled with the high regard of the Agency in the international arena, mean that the Agency's international commitments will not only remain high on its agenda, but will also grow in importance and volume.
French: La natura globale dello sviluppo e della ricerca nell'ambito dei medicinali, unitamente all'alta considerazione dell'Agenzia sullo scenario internazionale, mostrano che gli impegni internazionali dell'Agenzia occupano una posizione di primo piano sulla propria agenda, ma cresceranno anche in termini di volume e importanza.
English: The Agency will continue its contribution to an environment that stimulates innovation and availability of medicines through its core activities, such as provision of scientific advice to companies developing new medicines and implementation of the various policies supporting development of medicines.
French: L'Agenzia continuerà a fornire il proprio contributo a un ambiente che stimoli l'innovazione e la disponibilità dei medicinali per mezzo delle proprie attività principali, come la fornitura di consulenza scientifica a imprese che sviluppano nuovi medicinali e l'implementazione di varie politiche a sostegno dello sviluppo dei medicinali.
English: The Agency will launch its redesigned public website, which will provide easier access to information for patients, healthcare professionals and enterprises.
French: L'Agenzia lancerà il suo sito web ridisegnato, che fornirà un accesso più facile alle informazioni destinate a pazienti, operatori sanitari e imprese.
English: • continuing to improve the safety-monitoring of medicines;
French: • continuare a migliorare il monitoraggio sulla sicurezza nell'ambito dei medicinali;
English: These include the revision of the Variations Regulation, which brings new ways of handing variations, but also has implications for the Agency's financing, and the revised Maximum Residue Limits (MRL) Regulation, which promotes MRL extrapolation and extends the scope to cover biocidal products, as well as products used under the prescribing ‘cascade'.
French: Tra queste vi è la revisione del regolamento sulle variazioni, che contiene nuovi modi per gestire le variazioni, ma che ha anche implicazioni sul finanziamento dell'Agenzia, e il regolamento rivisto sui limiti massimi di residui (LMR), che promuove l'estrapolazione degli LMR ed estende l'ambito di applicazione ai prodotti biocidi e ai prodotti usati con riferimento all'”elenco” prescrittivo.
English: Taking into account the achievements to date, the trends and changes in the Agency's environment, the following areas of focus are identified for this year's work programme:
French: Considerando i traguardi raggiunti ad oggi, le tendenze e i cambiamenti nel contesto dell'Agenzia, al centro del programma di lavoro di quest'anno vi sono i seguenti settori:
English: Due to the nature of the work of the Agency, following the authorisation of new medicinal products, there is a cumulative increase in the work needed to supervise those products, carry out pharmacovigilance activities and conduct other post-authorisation tasks.
French: Per effetto della natura del lavoro dell'Agenzia, che si occupa dell'autorizzazione di nuovi medicinali, si assiste a un notevole aumento del lavoro necessario per esaminare tali prodotti, per svolgere attività di farmacovigilanza ed eseguire altre mansioni di post-autorizzazione.
English: As part of this contribution, the Agency leads a fiveyear collaborative European project with the goal of developing innovative methods in pharmacoepidemiology and pharmacovigilance.
French: Nell'ambito di tale contributo, l'Agenzia è alla guida di un progetto di collaborazione europeo, di durata quinquennale, che mira a sviluppare metodi innovativi nei settori della farmacoepidemiologia e della farmacovigilanza.
English: The focus in 2010 will include further implementation of the European risk-management strategy (ERMS), data-quality improvement in EudraVigilance, and support to the European Network of Centres for Pharmacovigilance and Pharmacoepidemiology.
French: Nel 2010 particolare attenzione sarà rivolta all'ulteriore implementazione della strategia europea di gestione del rischio (ERMS), al miglioramento della qualità dei dati nell'ambito di EudraVigilance, e al sostegno alla rete europea dei centri di farmacovigilanza e farmacoepidemiologia.
English: Further initiatives relating to provision of more information on benefit-risk assessment and rationale for decision-making will be implemented.
French: Inoltre verranno implementate ulteriori iniziative volte a fornire più informazioni sulla valutazione rischi-benefici oltre all'attuazione di logiche per la presa di decisioni.
English: Fields of activity include: the implementation of initiatives relating to clinical trials and manufacturing of active ingredients in China and India, and to international work-sharing activities in the field of GMP and GCP inspections; further collaboration with non-EU regulators in the context of confidentiality arrangements and mutual-recognition agreements; and contribution to international standardisation activities.
French: Tra i settori di attività figurano: l'implementazione di iniziative inerenti a test clinici e alla produzione di principi attivi in Cina e India, nonché le attività internazionali di condivisione del lavoro nell'ambito delle ispezioni GMP e GCP; ulteriore collaborazione con gli organi di regolamentazione extra UE nel contesto delle intese di confidenzialità e degli accordi di mutuo riconoscimento.
English: The European Commission issued a decision on this opinion on 22-09-2016.
French: La Commission européenne a adopté une décision relative à cet avis le 22-09-2016.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, France and Slovakia).
French: Il s'agit d'une procédure dans le cadre de laquelle un État membre (l'«État membre de référence», en l'occurrence le Royaume-Uni) évalue un médicament en vue d'accorder une autorisation de mise sur le marché qui sera valide dans ce pays ainsi que dans d'autres États membres (les «États membres concernés», en l'occurrence la France, la République tchèque et la Slovaquie).
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 5 February 2016.
French: Toutefois, les États membres n'ont pas pu parvenir à un accord et l'agence britannique de réglementation des médicaments a saisi le CHMP pour arbitrage le vendredi 5 février 2016.
English: This is because it is recommended that this product is preferably taken with food, and food can have a big effect on the way the medicine is taken up into the body.
French: En effet, il est conseillé de prendre ce produit de préférence pendant les repas, et les aliments peuvent avoir un effet important sur la manière dont le médicament est absorbé dans l'organisme.
English: Since some prostaglandins are involved in causing pain and inflammation at sites of injury or damage in the body, reduced prostaglandin production reduces pain and inflammation.
French: Puisque certaines prostaglandines sont à l'origine de la douleur et de l'inflammation aux sièges des blessures ou des lésions dans l'organisme, la production réduite de prostaglandines réduit la douleur et l'inflammation.
English: A review of scientific literature showed variable reductions in the uptake of different forms of diclofenac when taken with food.
French: Un examen de la littérature scientifique a mis en évidence des diminutions variables de l'absorption de différentes formes de diclofénac en présence d'aliments.
English: The medicine was to be marketed as Diclofenac.
French: Le médicament devait être commercialisé sous le nom Diclofenac.
English: The French and Slovakian medicines regulatory agencies considered that a bioequivalence study of the medicine taken with food was also required because it is recommended to be preferably taken with food.
French: Les agences françaises et slovaques de réglementation des médicaments ont considéré qu'une étude de bioéquivalence du médicament pris en présence d'aliments était également nécessaire, car il est conseillé de le prendre de préférence pendant les repas.
English: On 21 July 2016, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine diclofenac epolamine (50 mg tablets).
French: Le 21 juillet 2016, l'Agence européenne des médicaments a terminé une procédure d'arbitrage consécutive à un désaccord entre États membres de l'Union européenne (UE) concernant l'autorisation du médicament épolamine de diclofénac (comprimés 50 mg).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of this product do not outweigh its risks, and the marketing authorisation cannot be granted in the United Kingdom (UK) or in the following Member States of the EU: Czech Republic, France and Slovakia.
French: Le comité des médicaments à usage humain (CHMP) de l'Agence a conclu que les bénéfices de ce produit ne sont pas supérieurs à ses risques, et que l'autorisation de mise sur le marché ne peut pas être octroyée au Royaume-Uni, ni dans les États membres de l'UE suivants: France, République tchèque et Slovaquie.
English: The active substance in this medicine, diclofenac, is used for relief of pain and inflammation.
French: Le principe actif de ce médicament, le diclofénac, est utilisé pour soulager la douleur et l'inflammation.
English: Questions and answers on diclofenac epolamine 50 mg tablets EMA/490203/2016 Rev. 1
French: Questions et réponses relatives à l'épolamine de diclofénac, comprimés 50 mg EMA/490203/2016 Rev. 1
English: Based on the evaluation of currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicine when taken with food has not been shown.
French: Se fondant sur l'évaluation des données actuellement disponibles et sur la discussion scientifique menée au sein du comité, le CHMP a conclu que la bioéquivalence avec le médicament de référence en cas de prise au moment du repas n'a pas été démontrée.
English: Diclofenac is a ‘non-steroidal anti-inflammatory drug' (NSAID) which reduces the body's production of substances called prostaglandins.
French: Le diclofénac est un «anti-inflammatoire non stéroïdien» (AINS) qui réduit dans l'organisme la production de substances appelées prostaglandines.
English: The CHMP concluded that the benefits of these diclofenac epolamine 50 mg tablets do not outweigh their risks and recommended that marketing authorisation should not be granted in the UK or in the concerned Member States.
French: Le CHMP a conclu que les bénéfices de ces comprimés de 50 mg d'épolamine de diclofénac ne sont pas supérieurs à leurs risques, et a recommandé que l'autorisation de mise sur le marché ne soit pas octroyée au RoyaumeUni, ni dans les États membres concernés.
English: The CHMP therefore considered that the study of the medicine taken on an empty stomach only was not sufficient to show that this product is as effective as the reference medicine.
French: Le CHMP a donc estimé que l'étude du médicament pris à jeun uniquement ne suffisait pas à démontrer que ce produit est aussi efficace que le médicament de référence.
English: Altergon Italia srl submitted diclofenac epolamine (50 mg tablets) to the UK medicines regulatory agency for a decentralised procedure.
French: La société Altergon Italia srl a déposé une demande pour l'épolamine de diclofénac (comprimés 50 mg) auprès de l'agence britannique de réglementation des médicaments dans le cadre d'une procédure décentralisée.
English: EMA/490203/2016 Rev. 1 EMEA/H/A-29/1434
French: EMA/490203/2016 Rév.
English: Diclofenac epolamine (50 mg tablets) is a generic medicine based on a ‘reference medicine', Flector, which is authorised in France.
French: L'épolamine de diclofénac (comprimés 50 mg) est un médicament générique, dont le «médicament de référence», Flector, est autorisé en France.
English: The grounds for the referral were that the study performed had only shown the medicine was bioequivalent to the reference medicine when taken on an empty stomach.
French: Les motifs de la saisine étaient que l'étude réalisée avait seulement montré que le médicament était bioéquivalent au médicament de référence lorsqu'il était pris à jeun.
English: Questions and answers on diclofenac epolamine 50 mg tablets
French: Questions et réponses relatives à l'épolamine de diclofénac, comprimés 50 mg
English: Because diclofenac epolamine (50 mg tablets) is a generic medicine, a study has been carried out to show that it is bioequivalent to the reference medicine, Flector, which is available as diclofenac
French: Étant donné que l'épolamine de diclofénac (comprimés 50 mg) est un médicament générique, une étude a été réalisée pour démontrer qu'il est bioéquivalent au médicament de référence, Flector, qui est disponible sous forme de granulés d'épolamine de diclofénac permettant de préparer une solution buvable.
English: What is diclofenac epolamine (50 mg tablets)?
French: Qu'est-ce que l'épolamine de diclofénac (comprimés 50 mg)?
English: Why is diclofenac epolamine (50 mg tablets) reviewed?
French: Quelles étaient les raisons de l'examen de l'épolamine de diclofénac (comprimés 50 mg)?
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
French: ANNEXE I LISTE REPRENANT LES NOMS, LA FORME PHARMACEUTIQUE, LE DOSAGE DU MÉDICAMENT, LES VOIES D'ADMINISTRATION, LES TITULAIRE DE L'AUTORISATION DE MISE SUR LE MARCHE DANS LES ÉTATS MEMBRES
English: 102 53 Stockholm Sweden
French: 102 53 Stockholm Suède
English: Al. Jerozolimskie 146A 02-305 Warsaw Poland
French: Al. Jerozolimskie 146A 02-305 Warsaw Pologne
English: Sweden Nycomed AB Box 27264
French: Nycomed AB Box 27264
English: 4000 Roskilde
French: 4000 Roskilde Danemark
English: 176 74 Kallithea Greece
French: 176 74 Kallithea Grèce
English: Denmark Nycomed Denmark ApS Langebjerg 1
French: Nycomed Denmark ApS Langebjerg 1
English: Germany Byk Tosse Arzneimittel GmbH, Moltkestr.
French: Allemagne Byk Tosse Arzneimittel GmbH, Moltkestr.
English: Almirall S.p.A via Messina, 38 Torre C 20154 Milan Italy
French: Almirall S.p.A via Messina, 38 Torre C 20154 Milan Italie
English: Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5 1120 Vienna Austria
French: Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5 1120 Vienna Autriche
English: Via Temolo 4 20126 Milan Italy
French: Via Temolo 4 20126 Milan Italie
English: Nycomed Italia S.r.l via Libero Temolo 4 20126 Milan Italy
French: Nycomed Italia S.r.l via Libero Temolo 4 20126 Milan Italie
English: Somac 40 mg injektiokuivaaine, liuosta varten
French: Somac 40 mg injektiokuiva-aine, liuosta varten
English: Recordati Industria Chimica e Farmaceutica S.p.A Via M. Civitali 1
French: Recordati Industria Chimica e Farmaceutica S.p.A.
English: 78467 Konstance Germany
French: 78467 Konstance
English: Belgium Nycomed Belgium SCA/CVA Gentsesteenweg 615
French: Nycomed Belgium SCA/CVA Gentsesteenweg 615
English: Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Germany
French: Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Allemagne
English: Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany
French: Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Allemagne
English: Zurcal 40 mg -Trockenstechampulle
French: Zurcal 40 mgTrockenstechampulle
English: Germany Nycomed GmbH Byk-Gulden-Str.2
French: Allemagne Nycomed GmbH Byk-Gulden-Str.2
English: Netherlands Nycomed bv Jupiterstraat 250
French: Nycomed bv Jupiterstraat 250 2132 HK Hoofddorp Pays-Bas
English: Somac 20 mg enterotabletti 20 mg Gastro-resistant tablet
French: Somac 20 mg enterotabletti20 mg Comprimé gastro-résistantVoie orale
English: Somac 40 mg enterotabletti 40 mg Gastro-resistant tablet
French: Somac 40 mg enterotabletti40 mg Comprimé gastro-résistantVoie orale
English: Pantoprazol NYC 20 mg 20 mg Gastro-resistant tablet
French: Pantoprazol NYC 20 mg 20 mg Comprimé gastro-résistantVoie orale
English: Lithuania Nycomed GmbH Byk-Gulden-Str.2
French: Royaume-Uni Nycomed GmbH Byk-Gulden-Str.2
English: Pantoprazol NYC 40 mg 40 mg Gastro-resistant tablet
French: Pantoprazol NYC 40 mg 40 mg Comprimé gastro-résistantVoie orale
English: Belgium
French: Bulgarie
English: Pantoprazol Nycomed 40 mg40 mg Gastro-resistant tablet
French: Ulcotenal 40 mg Blister 40 mg Comprimé gastro-résistantVoie orale
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED BY THE MEMBER STATES The Member States should ensure that the MAH provides an educational programme for Remicade to ensure that physicians who intend to prescribe Remicade to paediatric Crohn's disease patients are aware of:
French: CONDITIONS OU RESTRICTIONS CONCERNANT LA SECURITE D'EMPLOI ET L'UTILISATION EFFICACE DU PRODUIT DEVANT ETRE PRISES EN CHARGE PAR LES ETATS-MEMBRES Les Etats-Membres doivent s'assurer que le titulaire de l'autorisation de mise sur le marché fournisse un programme d'éducation pour Remicade afin de s'assurer que les médecins ayant l'intention de prescrire Remicade aux enfants atteints de la maladie de Crohn soient informés:
English: • That children may be at increased risk of developing infections and the need for immunisations to be up to date.
French: • Que les enfants peuvent être exposés à un risque plus élevé de développer des infections et de la nécessité de mettre à jour les immunisations.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
French: ANNEXE CONDITIONS OU RESTRICTIONS CONCERNANT LA SECURITE D'EMPLOI ET L'UTILISATION EFFICACE DU PRODUIT DEVANT ETRE IMPLEMENTEES PAR LES ETATS-MEMBRES
English: • The risk of lymphoma and other malignancies.
French: • Du risque de lymphomes et autres tumeurs malignes.
English: • The patient alert card, which is to be given to patients using Remicade.
French: • De la carte de signalement patient, qui doit être délivrée aux patients ayant recours au Remicade.
English: • The risk of opportunistic infections and tuberculosis (TB) in patients treated with Remicade.
French: • Du risque d'infections opportunistes et tuberculose (TB) chez les patients traités par Remicade.
English: • The risk of acute infusion related reactions and delayed hypersensitivity reactions.
French: • Du risque de réaction aigüe à la perfusion et de réactions d'hypersensibilité retardée.
English: • The need to assess the risk of TB in patients prior to treating with Remicade.
French: • De la nécessité d'évaluer le risque de TB chez les patients avant de traiter par Remicade.
English: Magyarország Teva Gyógyszergyár Zrt.
French: Teva Gyógyszergyár Zrt.
English: The Prescriber Guide should highlight the following:
French: Le Guide du Prescripteur doit souligner les points suivants :
English: very common
French: très fréquent
English: Date of latest renewal: 17 February 2017
French: Date de première autorisation : 26 mars 2012 Date du dernier renouvellement : 17 février 2017
English: Your doctor will check whether Pioglitazone Teva Pharma is working 3 to 6 months after you start taking it.
French: Votre médecin vérifiera si Pioglitazone Teva Pharma est efficace 3 à 6 mois après que vous ayez commencé à le prendre
English: Children and adolescents Use in children and adolescents under 18 years is not recommended.
French: L'utilisation de ce médicament chez l'enfant et l'adolescent de moins de 18 ans n'est pas recommandée.
English: • The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
French: • Le pack éducationnel du médecin doit contenir : le Résumé des Caractéristiques du Produit, la notice et le Guide du Prescripteur.
English: Other medicines and Pioglitazone Teva Pharma Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
French: Autres médicaments et Pioglitazone Teva Pharma Informez votre médecin ou votre pharmacien si vous prenez, avez récemment pris ou pourriez prendre tout autre médicament.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
French: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Royaume-Uni
English: 98, 112 or 196 tablets.
French: 112 et 196 comprimés.
English: Do not take Pioglitazone Teva Pharma - if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
French: Ne prenez jamais Pioglitazone Teva Pharma - si vous êtes allergique à la pioglitazone ou à l'un des autres composants contenus dans ce médicament (mentionnés dans la rubrique 6).
English: Pioglitazone Teva Pharma helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
French: Pioglitazone Teva Pharma aide à contrôler votre taux de sucre sanguin lorsque vous avez un diabète de type 2, en permettant à votre corps de mieux utiliser l'insuline qu'il produit.
English: Pioglitazone Teva Pharma with food and drink You may take your tablets with or without food.
French: Pioglitazone Teva Pharma avec des aliments et des boissons Vous pouvez prendre vos comprimés avec ou en dehors d'un repas.
English: When Pioglitazone Teva Pharma is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
French: Quand Pioglitazone Teva Pharma est pris en association avec d'autres médicaments utilisés pour traiter le diabète (tels que insuline, chlorpropamide, glibenclamide, gliclazide, tolbutamide), votre médecin vous indiquera si vous devez prendre une dose plus faible de vos médicaments.
English: If you take more Pioglitazone Teva Pharma than you should If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
French: Si vous avez pris plus de comprimés de Pioglitazone Teva Pharma que vous n'auriez dû Si vous avez accidentellement pris trop de comprimés ou si une autre personne ou un enfant a pris votre médicament, informez en immédiatement votre médecin ou votre pharmacien.
English: Your blood sugar will be checked, and your dose of Pioglitazone Teva Pharma may need to be changed.
French: Votre taux de sucre sanguin sera vérifié, et la dose de Pioglitazone Teva Pharma peut être modifiée si besoin.
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Teva Pharma.
French: Vous pouvez généralement continuer à prendre d'autres médicaments alors que vous êtes traités avec Pioglitazone Teva Pharma.
English: Pioglitazone Teva Pharma has no or negligible influence on the ability to drive and use machines.
French: Pioglitazone Teva Pharma n'a aucun effet ou qu'un effet négligeable sur l'aptitude à conduire des véhicules et à utiliser des machines.