IBUPROFENE AGI Pharma

Information principale

  • Nom commercial:
  • IBUPROFENE AGI Pharma 5 %, gel
  • DCI (Dénomination commune internationale):
  • ibuprofen
  • Dosage:
  • 2,5 g
  • forme pharmaceutique:
  • gel
  • Composition:
  • composition pour 50 g de gel > ibuprofène : 2,5 g
  • Mode d'administration:
  • cutanée
  • Unités en paquet:
  • 1 tube(s) aluminium de 50 g
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • IBUPROFENE AGI Pharma 5 %, gel
    France
  • Langue:
  • français

Information thérapeutique

  • Descriptif du produit:
  • 377 493-7 ou 4009 377 493 7 4 - 1 tube(s) aluminium de 50 g - 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:
  • 68979726
  • Date de l'autorisation:
  • 18-12-2006
  • Dernière mise à jour:
  • 10-08-2017

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

NOTICE

Misàjour:18/12/2006

Dénominationdumédicament

IBUPROFENEAGIPHARMA5%,gel

Encadré

Veuillezlireattentivementcettenoticeavantd'utilisercemédicament.Ellecontientdesinformations

importantespourvotretraitement.

Sivousavezd'autresquestions,sivousavezundoute,demandezplusd'informationsàvotremédecinouà

votrepharmacien.

Gardezcettenotice,vouspourriezavoirbesoindelarelire.

Sivousavezbesoindeplusd'informationsetdeconseils,adressez-vousàvotrepharmacien.

Silessymptômess'aggraventoupersistent,consultezvotremédecin.

Sivousremarquezdeseffetsindésirablesnonmentionnésdanscettenotice,ousivousressentezun

deseffetsmentionnéscommeétantgrave,veuillezeninformervotremédecinouvotrepharmacien.

Sommairenotice

Danscettenotice:

1.QU'EST-CEQUEIBUPROFENEAGIPHARMA5%,gelETDANSQUELSCASEST-ILUTILISE?

2.QUELLESSONTLESINFORMATIONSACONNAITREAVANTD'UTILISERIBUPROFENEAGIPHARMA

5%,gel?

3.COMMENTUTILISERIBUPROFENEAGIPHARMA5%,gel?

4.QUELSSONTLESEFFETSINDESIRABLESEVENTUELS?

5.COMMENTCONSERVERIBUPROFENEAGIPHARMA5%,gel?

6.INFORMATIONSSUPPLEMENTAIRES

1.QU'EST-CEQUEIBUPROFENEAGIPHARMA5%,gelETDANSQUELSCASEST-ILUTILISE?

Classepharmacothérapeutique

Sansobjet.

Indicationsthérapeutiques

Cemédicamentcontientunanti-inflammatoirenonstéroïdien.Ilestindiqué,chezl'adulte(plusde15ans),en

traitementlocal:

destraumatismesbéninsdetypeentorsebénigne(foulure),contusions,

destendinites(inflammationdestendons).

2.QUELLESSONTLESINFORMATIONSACONNAITREAVANTD'UTILISERIBUPROFENEAGIPHARMA5

%,gel?

Listedesinformationsnécessairesavantlaprisedumédicament

Listedesinformationsnécessairesavantlaprisedumédicament

Sansobjet.

Contre-indications

N'utilisezjamaisIBUPROFENEAGIPHARMA5%,geldanslescassuivants:

àpartirdu6 ème moisdelagrossesse,

antécédentd'allergieàcemédicamentouàunmédicamentapparenté,notammentautresanti-

inflammatoiresnonstéroïdiens,aspirine,

antécédentd'allergieàl'undesexcipients,

peaulésée,quelquesoitlalésion:lésionssuintantes,eczéma,lésioninfectée,brûlureouplaie.

Précautionsd'emploi;misesengardespéciales

FaitesattentionavecIBUPROFENEAGIPHARMA5%,gel:

Cemédicamentestréservéàl'adulte(plusde15ans).

Nepasappliquersurlesmuqueuses,nisurlesyeux,

L'apparitiond'uneéruptioncutanéeaprèsapplicationdugelimposel'arrêtimmédiatdutraitement.

Encasd'utilisationfréquenteparunprofessionneldesanté,leportdegantsestrecommandé.

Bienselaverlesmainsaprèschaqueutilisation.

Interactionsavecd'autresmédicaments

Priseouutilisationd'autresmédicaments

Veuillezindiqueràvotremédecinouàvotrepharmaciensivousprenezouavezprisrécemmentunautre

médicament,mêmes'ils'agitd'unmédicamentobtenusansordonnance.

Cegelcontientunanti-inflammatoirenonstéroïdien:l'ibuprofène.

Vousnedevezpasprendreenmêmetempsquecemédicamentd'autresmédicamentsdestinésàêtre

appliquéssurlapeaucontenantdel'ibuprofèneet/oudesanti-inflammatoiresnonstéroidiens.

Lisezattentivementlesnoticesdesautresmédicamentsquevousprenezafindevousassurerdel'absence

d'ibuprofèneet/oud'anti-inflammatoiresnonstéroidiens.

Interactionsaveclesalimentsetlesboissons

Sansobjet.

Interactionsaveclesproduitsdephytothérapieouthérapiesalternatives

Sansobjet.

Utilisationpendantlagrossesseetl'allaitement

Grossesseetallaitement

Grossesse

Cemédicamentneserautilisépendantles5PREMIERSMOISdelagrossessequesurlesconseilsdevotre

médecin.

Apartirdu6 ème

moisdelagrossesse,vousnedevezENAUCUNCASprendredeVOUSMEMEce

médicament.Bienquelepassagedecemédicamentdanslacirculationgénéralesoitfaible,ilnepeutêtre

exclu.Danscecas,l'effetdecemédicamentsurvotreenfantpourraitavoirdesconséquencesgraves,

notammentauplancardio-pulmonaireetrénal,etcela,mêmeavecuneseuleapplication.

Demandezconseilàvotremédecinouàvotrepharmacienavantdeprendretoutmédicament.

Demandezconseilàvotremédecinouàvotrepharmacienavantdeprendretoutmédicament.

Allaitement

LesA.I.N.Spassantdanslelaitmaternel,parmesuredeprécaution,ilconvientd'éviterdelesadministrer

chezlafemmequiallaite.

Demandezconseilàvotremédecinouàvotrepharmacienavantdeprendretoutmédicament.

Sportifs

Sansobjet.

Effetssurl'aptitudeàconduiredesvéhiculesouàutiliserdesmachines

Sansobjet.

Listedesexcipientsàeffetnotoire

Sansobjet.

3.COMMENTUTILISERIBUPROFENEAGIPHARMA5%,gel?

Instructionspourunbonusage

Sansobjet.

Posologie,Modeet/ouvoie(s)d'administration,Fréquenced'administrationetDuréedutraitement

Posologie

RESERVERAL'ADULTE(plusde15ans).

Moded'administration/Fréquenced'administration

Voielocale.

Laposologieusuelleestde1application,3foisparjour,surlazonedouloureuse.

Fairepénétrerlegelparunmassagedouxetprolongé,surlarégiondouloureuseouinflammatoire.

Bienselaverlesmainsaprèschaqueutilisation.

Duréedetraitement

Letraitementestlimitéà5joursenl'absencedeprescriptionmédicale.

Symptômesetinstructionsencasdesurdosage

SivousavezutiliséplusdeIBUPROFENEAGIPHARMA5%,gelquevousn'auriezdû:

Rincezabondammentàl'eau.

Instructionsencasd'omissiond'uneoudeplusieursdoses

Sivousoubliezd'appliquerIBUPROFENEAGIPHARMA5%,gel:

Neprenezpasdedosedoublepourcompenserladosesimplequevousavezoubliédeprendre.

Risquedesyndromedesevrage

Sansobjet.

4.QUELSSONTLESEFFETSINDESIRABLESEVENTUELS?

Descriptiondeseffetsindésirables

Commetouslesmédicaments,IBUPROFENEAGIPHARMA5%,gelestsusceptibled'avoirdeseffets

indésirables,bienquetoutlemonden'ysoitpassujet:

Exceptionnellement,peuventsurvenirdesréactionsallergiques:

cutanées,

cutanées,

respiratoiresdetypecrised'asthme,

générales.

Danstouscescas,ilfautimmédiatementarrêterletraitementetavertirvotremédecin.

Peuventsurvenirégalement:

deseffetslocauxcutanésdetyperougeurs,démangeaisons,

d'autreseffetsgénérauxdesanti-inflammatoiresnonstéroïdiens,fonctiondelaquantitédegel

appliquée,delasurfacetraitéeetdesonétat,deladuréedetraitementetdel'utilisationounond'un

pansementfermé.

Danstouscescas,avertirvotremédecin.

Sivousremarquezdeseffetsindésirablesnonmentionnésdanscettenotice,ousicertainseffetsindésirables

deviennentgraves,veuillezeninformervotremédecinouvotrepharmacien.

5.COMMENTCONSERVERIBUPROFENEAGIPHARMA5%,gel?

Tenirhorsdelaportéeetdelavuedesenfants.

Datedepéremption

NepasutiliserIBUPROFENEAGIPHARMA5%,gelaprèsladatedepéremptionmentionnéesurlaboîte.

Conditionsdeconservation

Aconserveràl'abridelalumière.

Sinécessaire,misesengardecontrecertainssignesvisiblesdedétérioration

Lesmédicamentsnedoiventpasêtrejetésautoutàl'égoutouaveclesorduresménagères.Demandezà

votrepharmaciencequ'ilfautfairedesmédicamentsinutilisés.Cesmesurespermettrontdeprotéger

l'environnement.

6.INFORMATIONSSUPPLEMENTAIRES

Listecomplètedessubstancesactivesetdesexcipients

QuecontientIBUPROFENEAGIPHARMA5%,gel?

Lasubstanceactiveest

Ibuprofène...........................................................................................................................................2,5

Pour50gdegel.

Lesautrescomposantssont:

Hydroxyéthylcellulose,hydroxydedesodium,alcoolbenzylique,alcoolisopropylique,eaupurifiée.

Formepharmaceutiqueetcontenu

Qu'est-cequeIBUPROFENEAGIPHARMA5%,geletcontenudel'emballageextérieur?

Cemédicamentseprésentesousformedegel.Tubede50g.

Nometadressedutitulairedel'autorisationdemisesurlemarchéetdutitulairedel'autorisationde

fabricationresponsabledelalibérationdeslots,sidifférent

Titulaire

SociétéAGIPHARMA

40,ruedesBergers

40,ruedesBergers

75015Paris

Exploitant

PHARMADEVELOPPEMENT

ChemindeMarcy

58800CORBIGNY

Fabricant

PHARMADEVELOPPEMENT

ChemindeMarcy

58800CORBIGNY

NomsdumédicamentdanslesEtatsmembresdel'EspaceEconomiqueEuropéen

Sansobjet.

Dated’approbationdelanotice

Ladernièredateàlaquellecettenoticeaétéapprouvéeestle{date}.

AMMsouscirconstancesexceptionnelles

Sansobjet.

InformationsInternet

DesinformationsdétailléessurcemédicamentsontdisponiblessurlesiteInternetdel’Afssaps(France).

Informationsréservéesauxprofessionnelsdesanté

Sansobjet.

Autres

CONSEILS/EDUCATIONSANITAIRE

Vousvenezd’avoiruntraumatismeouunecontusion,vouspouvezutiliserlegelpoursoulagervotredouleur,mais:

encasd’entorsedelacheville

L’entorsebénigneoufoulure,n’entraînepasdecraquementnidesensationdedéboîtement.

Ladouleurinitialeestviteamélioréeparlamiseaurepos(24hà48h).

L’impotencefonctionnelleestquasiinexistante,mêmesilamarcheestlégèrementdouloureuse.Toutsignedegravité

immédiat,persistantouapparaissantsecondairementtelsque:douleurpulsatile,hématomeimportant,ecchymose

plantairedupied,doitvousameneràconsulterrapidementvotremédecin.

Enpratique:

Sivousavezplusde55ans,

Sivousnepouvezabsolumentpasvousmettreenappuisurlajambepourfairequatrepas,

Ousiunhématome(bleu)apparaîtdansles24hà48hous’ilexisteunedéformationouunoedème(gonflement)très

important,vousdevezconsultervotremédecinquiseuljugeradelanécessitéd’uneradiographieetd’untraitement

orthopédique;

encasdelésiondugenou

Sivousavezplusde55ans,

Encasdegonflementimportantdugenouavecousanshématomeet/oud’impossibilitéd’appui,vousdevezaussi

consultervotremédecin;

danstouslescas

S’ilexisteuneimpotencefonctionnellecomplète,c’est-à-diresivousnepouvezvousservirdumembresupérieuroudu

membreinférieuretencasd’hématome(«bleu»)important,vousdevezaussiconsultersanstardervotremédecin.

12-12-2018

Nettoyants Lemieux recalls Concentrated Dishwasher Powder

Nettoyants Lemieux recalls Concentrated Dishwasher Powder

Health Canada has determined that the recalled product does not comply with Canadian packaging and labeling regulations.

Health Canada

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

4-12-2018

Surveillance du marché

Surveillance du marché

Une fois l’autorisation de mise sur le marché (AMM) délivrée, et au-delà de la pharmacovigilance, une surveillance du marché des médicaments vétérinaires est assurée sous différents aspects.

France - Agence Nationale du Médicament Vétérinaire

28-11-2018

Minister Bruno Bruins bereikt akkoord over openbare verlaging van prijzen voor geneesmiddelen tegen hepatitis C

Minister Bruno Bruins bereikt akkoord over openbare verlaging van prijzen voor geneesmiddelen tegen hepatitis C

Minister Bruno Bruins voor Medische Zorg heeft besloten acht nieuwe medicijnen tegen chronische hepatitis C te blijven vergoeden. Tot nu toe golden vertrouwelijke prijsafspraken voor deze middelen, maar die zijn vanaf 1 januari 2019 niet meer nodig. Twee leveranciers hebben gehoor gegeven aan een oproep van de minister voor een openbare prijsverlaging.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

20-11-2018

Pest categorisation of non‐EU Monochamus spp.

Pest categorisation of non‐EU Monochamus spp.

Published on: Mon, 19 Nov 2018 The Panel on Plant Health performed a pest categorisation of non‐EU Monochamus spp., a well‐defined insect genus in the family Cerambycidae (Insecta: Coleoptera). Species can be identified using taxonomic keys at national and regional level, and DNA barcoding. Two online world catalogues exist for the genus. The genus includes about one hundred species and many subspecies colonising conifers and non‐conifer trees in many areas in the world. The non‐EU species are listed in...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

Indigo Books & Music Inc. rappelle les tentes de jeu WellieWishers Magic Theater d'American Girl

Indigo Books & Music Inc. rappelle les tentes de jeu WellieWishers Magic Theater d'American Girl

Les tentes de jeu ne respectent pas les exigences d'inflammabilité des tentes établies dans la loi canadienne. Les tentes peuvent s'enflammer si elles sont exposées à une flamme ou à une autre source d'inflammation, ce qui présente un risque de brûlures.

Canadiens en santé

19-11-2018

Indigo Books & Music Inc. recalls American Girl WellieWishers Magic Theater Play Tent

Indigo Books & Music Inc. recalls American Girl WellieWishers Magic Theater Play Tent

The play tent does not meet the requirements for tent flammability under Canadian law. The tents could catch fire if exposed to a flame or other ignition source, and pose possible fire and burn hazards to consumers.

Health Canada

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Manage Your Asthma: Know Your Triggers and Treatment Options

Manage Your Asthma: Know Your Triggers and Treatment Options

You can manage your asthma by taking medications approved by the FDA. Before going to the pharmacy, get a proper diagnosis from a doctor and together develop an asthma action plan.

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

7-11-2018

Rappel de plusieurs comprimés pour soulager la douleur ou le mal des sinus de marques maison parce que les consommateurs peuvent être incapables d’accéder à d’importants renseignements sur l’innocuité

Rappel de plusieurs comprimés pour soulager la douleur ou le mal des sinus de marques maison parce que les consommateurs peuvent être incapables d’accéder à d’importants renseignements sur l’innocuité

L’entreprise Vita Health Products procède au rappel volontaire de nombreux médicaments en vente libre pour soulager la douleur et le mal des sinus des marques maison Care, Exact, Life et Pharmasave en raison d’un problème d’étiquetage. Il se pourrait que les consommateurs ne réussissent pas à décoller l’étiquette enveloppante de la bouteille pour voir les mises en garde. Il se pourrait aussi que l’étiquette ne se décolle pas complètement, ce qui rend difficile la lecture d’importants renseignements sur l...

Canadiens en santé

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

18-10-2018

ACM PHARMA - BELLEGARDE

ACM PHARMA - BELLEGARDE

France - Agence Nationale du Médicament Vétérinaire

3-10-2018

Prijsonderhandelingen dure medicijnen leiden tot forse kostenverlaging

Prijsonderhandelingen dure medicijnen leiden tot forse kostenverlaging

Sinds enkele jaren onderhandelt de minister voor Medische Zorg met fabrikanten van nieuwe en zeer dure geneesmiddelen. Doel is om deze waardevolle innovatieve geneesmiddelen tegen aanvaardbare kosten toegankelijk te maken en te houden voor de patiënt. Dit heeft in 2017 geleid tot een kostenverlaging van in totaal 132 miljoen euro. Dat heeft minister Bruno Bruins aan de Tweede Kamer laten weten. Op basis van de prijs die fabrikanten eerst vroegen zou er sprake zijn van 457 miljoen aan uitgaven aan de betr...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

2-10-2018

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

Despite medical advances, cancer remains the leading cause of death in France.  While active smoking, alcohol consumption and an unbalanced diet continue to be the main causes of cancer mortality, the environment has a real impact on the risk of cancer, although it remains difficult to assess.

France - Agence Nationale du Médicament Vétérinaire

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

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

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

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

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

11-12-2018

Xermelo (Ipsen Pharma)

Xermelo (Ipsen Pharma)

Xermelo (Active substance: telotristat) - Centralised - Yearly update - Commission Decision (2018)8684 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Alunbrig (Takeda Pharma A/S)

Alunbrig (Takeda Pharma A/S)

Alunbrig (Active substance: brigatinib) - Centralised - Authorisation - Commission Decision (2018)7976 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4248/

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (Active substance: Setmelanotide) - Orphan designation - Commission Decision (2018)7811 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/143/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Active substance: Glucagon) - Orphan designation - Commission Decision (2018)7801 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/108/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (Active substance: Allogeneic faecal microbiota, pooled) - Orphan designation - Commission Decision (2018)7792 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/123/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

29-10-2018

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Active substance: efavirenz) - Centralised - 2-Monthly update - Commission Decision (2018)7252 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/249/II/145/G

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

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 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

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety