Clarinase Once daily

Hauptinformation

  • Handelsname:
  • Clarinase Once daily Retardtablette 10 mg-240 mg
  • Dosierung:
  • 10 mg-240 mg
  • Darreichungsform:
  • Retardtablette
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Clarinase Once daily Retardtablette 10 mg-240 mg
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Antihistaminika – H 1 -Antagonisten, ATC-code: R06A X13. Pharmakotherapeutische Gruppe: Nasale abschwellende für den systemische

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE175375
  • Letzte Änderung:
  • 07-04-2018

Packungsbeilage

GEBRAUCHSINFORMATION: INFORMATION FÜR DEN ANWENDER

Clarinase® Once Daily 10 mg/240 mg Retardtabletten

Loratadin/Pseudoephedrinsulfat

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Anwendung dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter. Es

kann anderen Menschen schaden, auch wenn diese dieselben Beschwerden haben wie Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt

auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Siehe Abschnitt

Was in dieser Packungsbeilage steht

Was ist Clarinase Once Daily und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von Clarinase Once Daily beachten?

Wie ist Clarinase Once Daily einzunehmen?

Welche Nebenwirkungen sind möglich?

Wie ist Clarinase Once Daily aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

WAS IST CLARINASE ONCE DAILY UND WOFÜR WIRD ES ANGEWENDET?

Was Clarinase Once Daily ist

Clarinase Once Daily Tabletten enthält eine Kombination aus zwei Arzneimitteln (Loratadin und

Pseudoephedrinsulfat). Loratadin ist ein Antihistaminikum und Pseudoephedrinsulfat ist

ein Dekongestivum (einem Schleimhaut abschwellenden Arzneimittel).

Wie Clarinase Once Daily wirkt

Clarinase Once Daily Tabletten tragen dazu bei, die Symptome Ihrer Allergie oder gewöhnlichen

Erkältung zu lindern, indem sie die Wirkungen einer „Histamin“ genannten Substanz blockieren, die

durch den Körper produziert wird, wenn Sie gegen etwas allergisch sind.

Dekongestiva lindern die Verstopfung der Nase.

Wann Clarinase Once Daily verwendet werden sollte

Clarinase Once Daily Tabletten lindert Symptome, die in Zusammenhang mit saisonaler allergischer

Rhinitis (Heuschnupfen) auftreten, wie Niesen, laufende oder juckende Nase und tränende oder

juckende Augen bei gleichzeitiger Verstopfung der Nase bei Erwachsenen und Kindern von 12 Jahren

und älter.

2.

WAS SOLLTEN SIE VOR DER ANWENDUNG VON CLARINASE ONCE DAILY BEACHTEN?

Clarinase Once Daily darf nicht eingenommen werden,

wenn Sie allergisch (überempfindlich) gegen Loratadin, Pseudoephedrinsulfat oder einen der

sonstigen Bestandteile von Clarinase Once Daily Tabletten sind.

Da Clarinase Once Daily Pseudoephedrinsulfat enthält, darf es nie eingenommen werden wenn

Sie auch Arzneimittel für das Herz oder den Blutdruck anwenden,

Sie Glaukom, Schwierigkeiten beim Wasserlassen, eine Verlegung der Harnwege, hohen

Blutdruck, Herz- oder Gefäßerkrankungen, einen Schlaganfall in der Anamnese oder eine

Schilddrüsenüberfunktion haben,

Sie mit Monoaminoxidasehemmern (MAO-Hemmer) (Arzneimittel, das bei Depression

angewendet wird) behandelt werden oder in den vergangenen zwei Wochen einer solchen

Behandlung abgesetzt haben.

Warnhinweise und Vorsichtsmaßnahmen

Unter bestimmten Umständen können Sie besonders empfindlich gegenüber dem Schleimhaut

abschwellenden Arzneimittel Pseudoephedrin sein, das in diesem Arzneimittel enthalten ist.

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker bevor Sie Clarinase Once Daily Tabletten

einnehmen wenn

Sie im Alter von 60 Jahren oder älter sind. Ältere Personen können empfindlicher gegen

Wirkungen dieses Arzneimittels sein,

Sie Diabetes mellitus (Zuckerkrankheit), ein stenosierendes Ulkus pepticum (Geschwür, das zur

Verengung von Magen, Dünndarm oder Speiseröhre führt), eine pyloroduodenale Obstruktion

(Darmblockade), eine Blockade des Harnblasenhalses, Bronchospasmen in der Anamnese

(Atembeschwerden aufgrund einer Anspannung der Lungenmuskulatur), oder Probleme mit

Leber, Nieren oder Blase haben,

Sie sich einem chirurgischen Eingriff unterziehen müssen, weil ein Absetzen der Behandlung mit

Clarinase Once Daily während einigen Tagen erforderlich sein kann,

Sie Digitalispräparate, Arzneimittel zur Behandlung mancher Herzstörungen, einnehmen, weil

eine Anpassung der Dosierung erforderlich sein kann,

Sie α-Methyldopa, Mecamylamin, Reserpin, Veratrumalkaloiden, Guanethidin zur Behandlung

des Blutdrucks einnehmen, weil eine Anpassung der Dosierung erforderlich sein kann,

Sie abschwellende Arzneimittel (oral oder nasal), Anorektika (Appetitzügler) oder Amphetamine

einnehmen, denn zusammen mit Clarinase Once Daily können diese Arzneimittel Ihren Blutdruck

erhöhen,

Sie Mutterkorn-Alkaloide (wie Dihydroergotamin, Ergotamin, Methylergometrin) zur

Migränebehandlung einnehmen. Zusammen mit Clarinase Once Daily können diese Arzneimittel

Ihren Blutdruck erhöhen,

Sie Linezolid (ein Antibiotikum), Bromocriptin (bei Unfruchtbarkeit oder Parkinson-Krankheit),

Cabergolin, Lisurid und Pergolid (bei Parkinson-Krankheit) einnehmen. Zusammen mit Clarinase

Once Daily können diese Arzneimittel Ihren Blutdruck erhöhen,

Sie Antazida gegen Sodbrennen einnehmen, denn sie können die Wirkung von Clarinase Once

Daily erhöhen,

Sie Kaolin gegen Durchfall einnehmen, denn das kann die Wirkung von Clarinase Once Daily

senken,

Sie Hauttests wegen möglicher Allergien absolvieren müssen, sollten Sie Clarinase Once Daily

zwei Tage vor diesen Tests nicht einnehmen, da dieses Arzneimittel die Testergebnisse

beeinflussen kann.

Informieren Sie Ihren Arzt, wenn bei Ihnen unter der Anwendung von Clarinase Once Daily folgende

Symptome oder Erkrankungen auftreten oder diagnostiziert werden:

Bluthochdruck,

Herzjagen, Herzklopfen,

unregelmäßiger Herzschlag,

Übelkeit und Kopfschmerzen oder eine Verstärkung bestehender Kopfschmerzen. Ihr Arzt kann

Ihnen dazu raten, das Arzneimittel abzusetzen.

Bei einem der Bestandteile von Clarinase Once Daily, Pseudoephedrinsulfat, besteht die Gefahr eines

Missbrauchs. Pseudoephedrinsulfat kann in großen Mengen giftig sein.

In Einzelfällen kann bei Pseudoephedrin-haltigen Produkten eine akute generalisierte exanthematöse

Pustulose (AGEP) auftreten, eine Art von schwerer Hautreaktion. Sollten Sie Anzeichen und

Symptome wie Fieber, Erythem oder kleine (generalisierte) Pusteln beobachten, sollten Sie das

Arzneimittel nicht weiter verwenden und Ihren Arzt konsultieren.

Kinder

Dieses Arzneimittel darf bei Kindern unter 12 Jahren nicht verabreicht werden.

Einnahme von Clarinase Once Daily zusammen mit anderen Arzneimitteln

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen, kürzlich andere

Arzneimittel eingenommen haben oder beabsichtigen andere Arzneimittel einzunehmen.

Das gilt auch wenn es sich um nicht verschreibungspflichtige Arzneimittel handelt.

Einnahme von Clarinase Once Daily zusammen mit Alkohol

Es ist nicht bewiesen, dass die Wirkung von alkoholischer Getränke durch die gleichzeitige Einnahme

von Clarinase Once Daily verstärkt wird.

Schwangerschaft, Stillzeit und Fortpflanzungsfähigkeit

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein oder

beabsichtigen, schwanger zu werden, fragen Sie vor der Einnahme dieses Arzneimittel Ihren Arzt

oder Apotheker um Rat.

Schwangerschaft

Wenn Sie schwanger sind, dürfen Sie Clarinase Once Daily nicht einnehmen.

Stillzeit

Wenn Sie stillen, dürfen Sie Clarinase Once Daily nicht einnehmen.

Loratadin und Pseudoephedrin gehen in die Muttermilch über. Von verminderter Milchproduktion

bei stillenden Müttern wurde im Zusammenhang mit Pseudoephedrin, einem Bestandteil von

Clarinase Once Daily, berichtet.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Bei Anwendung in der empfohlenen Dosierung führt Clarinase Once Daily normalerweise nicht zu

Schläfrigkeit und wird die Aufmerksamkeit nicht herabgesetzt. Sehr selten entwickeln manche

Personen jedoch Schläfrigkeit, die zu einer Beeinträchtigung der Verkehrstüchtigkeit oder der

Fähigkeit zum Bedienen von Maschinen führen kann.

Clarinase Once Daily enthält Saccharose

Clarinase Once Daily Retardtabletten enthält Saccharose.

Nehmen Sie dieses Arzneimittel erst nach Rücksprache mit Ihrem Arzt ein, wenn Ihnen bekannt ist,

dass Sie unter einer Zuckerunverträglichkeit leiden.

Labortests

Athleten, die Clarinase Once Daily Tabletten einnehmen, können einen positiven Doping-Test haben.

3.

WIE IST CLARINASE ONCE DAILY EINZUNEHMEN?

Nehmen Sie dieses Arzneimittel immer genau nach Absprache mit Ihren Arzt oder Apotheker. Fragen

Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht sicher sind.

Wie viel ist einzunehmen:

Erwachsene und Jugendliche im Alter von 12 Jahren und älter

Die empfohlene Dosis beträgt 1 Clarinase Once Daily Retardtablette einmal täglich mit einem Glas

Wasser, mit oder ohne Nahrung.

Dieses Arzneimittel ist zum Einnehmen bestimmt.

Schlucken Sie die Tablette als Ganzes ohne sie zu zerbeißen, zu zerbrechen oder zu kauen, bevor Sie

sie schlucken.

Nehmen Sie nicht mehr Clarinase Once Daily Tabletten ein als empfohlen. Nehmen Sie die Tabletten

nicht häufiger ein als empfohlen.

Falls von Ihrem Arzt nicht anders verordnet, sollten Sie dieses Arzneimittel nicht länger als 10 Tage

nacheinander einnehmen.

Wenn Sie eine größere Menge von Clarinase Once Daily eingenommen haben, als Sie sollten

Wenn Sie eine Überdosis einnehmen, wenden Sie sich sofort an Ihren Arzt oder Apotheker.

Über Fälle von Schläfrigkeit, beschleunigten Herzschlag und Kopfschmerzen wurde bei einer

Überdosis mit Loratadin, einem Bestandteil von Clarinase Once Daily berichtet. Über Fälle von

Krampfanfällen, beschleunigten Herzschlag, Übelkeit und Nervosität wurde bei einer Überdosis mit

Pseudoephedrin, einem Bestandteil von Clarinase Once Daily berichtet.

Wenn Sie eine größere Menge von Clarinase Once Daily haben eingenommen, kontaktieren Sie

sofort Ihren Arzt, Ihren Apotheker oder das Antigiftzentrum (070/245.245).

Wenn Sie die Einnahme von Clarinase Once Daily vergessen haben

Wenn Sie die Einnahme Ihrer Dosis vergessen haben, holen Sie diese so bald wie möglich

nach und setzen Sie die Einnahme dann wie üblich fort.

Nehmen Sie nicht die doppelte Menge ein, wenn Sie die vorherige Einnahme vergessen

haben.

Wenn Sie weitere Fragen zur Anwendung dieses Arzneimittels haben, wenden Sie an Ihren Arzt oder

Apotheker.

4.

WELCHE NEBENWIRKUNGEN SIND MÖGLICH?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei

jedem auftreten müssen.

Wenden Sie sich sofort an einen Arzt oder Apotheker, wenn Sie eine Reaktion auf Clarinase Once

Daily feststellen, die anhält, störend ist oder die Sie für schwer halten.

Häufige Nebenwirkungen (können bis zu 1 von 10 Personen betreffen), die in Verbindung mit

Clarinase Once Daily 10 mg/240 mg Retardtabletten gemeldet wurden, umfassen: Nervosität,

Anorexie, Schläfrigkeit, Schlafstörungen, Schwindel, Überaktivität, Mundtrockenheit und Müdigkeit.

Weniger häufige Nebenwirkungen umfassen schnellen oder unregelmäßigen, Nasenbluten, eine

Entzündung der Nasenschleimhaut, Verstopfung und Übelkeit.

Die folgenden sehr seltenen Nebenwirkungen (können bis zu 1 von 10.000 Personen betreffen)

wurden auch während des Inverkehrbringens von Clarinase Once Daily beobachtet: schwere

allergische Reaktion mit Ausschlag, Quaddeln und Schwellung des Gesichts, Drehschwindel,

Konvulsionen, Herzrhythmusstörungen, Bluthochdruck, Husten, Verengung der Atemwege,

Leberprobleme, Schwierigkeiten beim Wasserlassen und Haarausfall wurden gemeldet.

Weitere Nebenwirkungen, die im Rahmen klinischer Studien und nach Markteinführung nur mit

Loratadin berichtet wurden, umfassen Appetitsteigerung, Hautausschlag und Magenverstimmung.

Zu den nach dem Inverkehrbringen gemachten Erfahrungen zählen Einzelfälle akuter generalisierter

exanthematöser Pustulosen (AGEP), eine Art von schwerer Hautreaktion, die bei Pseudoephedrin-

haltigen Produkten gemeldet wurde.

Die Häufigkeit der folgenden Nebenwirkungen ist nicht bekannt:

Gewichtszunahme.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt auch

für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Sie können

Nebenwirkungen auch anzeigen direkt über:

Belgien:

Föderalagentur für Arzneimittel und Gesundheitsprodukte

Abteilung Vigilanz

EUROSTATION II

Victor Hortaplein, 40/40

B-1060 BRUSSEL

Website: www.fagg-afmps.be

E-Mail: patientinfo@fagg-afmps.be

Für Großherzogtum Luxemburg: http://www.ms.public.lu

Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr Informationen über die

Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5.

WIE IST CLARINASE ONCE DAILY AUFZUBEWAHREN?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Für dieses Arzneimittel sind bezüglich der Temperatur keine besonderen Lagerungsbedingungen

erforderlich. In der Originalverpackung aufbewahren um den Inhalt vor Feuchtigkeit zu schützen.

Nicht einfrieren.

Sie dürfen dieses Arzneimittel nach dem auf dem Umkarton und der Blisterpackung nach EXP

angegebenen Verfalldatum nicht mehr anwenden. Das Verfalldatum bezieht sich auf den letzten

Tag des Monats.

Sie dürfen dieses Arzneimittel nicht verwenden, wenn Sie eine Veränderung des Aussehens der

Tabletten bemerken.

Enstorgen Sie Arzneimittel nicht im Abwasser oder Haushaltsabfall. Fragen Sie Ihren Apotheker,

wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr verwenden. Sie tragen damit zum

Schutz der Umwelt bei.

6.

INHALT DER PACKUNG UND WEITERE INFORMATIONEN

Was Clarinase Once Daily enthält

Die Wirkstoffe von Clarinase Once Daily Retardtabletten sind: Loratadin 10 mg und

Pseudoephedrinsulfat 240 mg.

Die sonstigen Bestandteile sind: Hypromellose, Ethylcellulose, Calciumhydrogenphosphat-

Dihydrat, Povidon, Siliciumdioxid und Magnesiumstearat; Überzug - Macrogol 3350,

Hypromellose 2910, OPASPRAY weiß K-1-7000 (Titandioxid E 171, Hyprolose E 463), Saccharose,

Macrogol 400, Carnaubawachs, gebleichtes Bienenwachs.

Wie Clarinase Once Daily aussieht und Inhalt der Packung

Clarinase Once Daily 10mg/240 mg Retardtabletten ist erhältlich in Blisterpackung in Schachteln mit

1, 7, 10, 14, 20, 28, 30, 50 und 100.

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer und Hersteller

Pharmazeutischer Unternehmer:

Bayer SA-NV, J.E. Mommaertslaan 14, B-1831 Diegem (Machelen)

Hersteller:

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Niederlande

Oder

SAG Manufacturing S.L.U.

Km. 36, Carretera Nacional 1

28750 San Agustin de Guadalix

Madrid

Spanien

Zulassungsnummer

BE 175375

Verkaufsabgrenzung

Dieses Arzneimittel ist verschreibungspflichtig oder erhältlich auf schriftliche Anfrage

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR) unter

den folgenden Bezeichnungen zugelassen:

Clarinase Once Daily: Belgien, Luxemburg

Clarinase: Dänemark, Island

Clarityne-D 240/10: Griechenland

Claridon QD: Portugal

Clarityne Plus 10mg/240mg: Spanien

Diese Packungsbeilage wurde zuletzt genehmigt im 02/2018.

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

FDA - U.S. Food and Drug Administration

11-9-2018

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

Health Canada

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

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

4-9-2018

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

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

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

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 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

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

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

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

2-8-2018

The 2017 ANSES Annual Report is now available !

The 2017 ANSES Annual Report is now available !

At a time when its responsibilities are being extended, ANSES is consolidating its position as a protector of public health. With a field of action that covers all the risks to which the population may be exposed on a daily basis, the Agency confirms its scientific expertise capability and its mission to assess risks in situations of uncertainty.

France - Agence Nationale du Médicament Vétérinaire

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital 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

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

29-5-2018

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous ...

FDA - U.S. Food and Drug Administration

17-5-2018

FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products

FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products

FDA continued to take important steps to address youth use of e-cigarettes by sending official requests for information to four e-cigarette makers requiring them to submit important documents to better understand the youth appeal.

FDA - U.S. Food and Drug Administration

16-5-2018

FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

FDA - U.S. Food and Drug Administration

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

6-4-2017

More batches of EpiPen® are withdrawn

More batches of EpiPen® are withdrawn

MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

17-3-2017

Withdrawal of a batch of EpiPen® 300 micrograms

Withdrawal of a batch of EpiPen® 300 micrograms

MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

Danish Medicines Agency

23-2-2016

Form for notification of invoice details concerning clinical trials discontinued

Form for notification of invoice details concerning clinical trials discontinued

The Danish Medicines Agency has decided to discontinue the form for notification of invoice details concerning clinical trials. Instead, the cover letter should provide details of who we should send the invoice to and any comments you want us to state on the invoice.

Danish Medicines Agency

27-3-2012

Illegal potency-enhancing drug in Denmark: Viamax Pure Power

Illegal potency-enhancing drug in Denmark: Viamax Pure Power

The Danish National Board of Health has received information about the dangerous potency-enhancing product Viamax Pure Power, which is sold by Danish online shops. Viamax Pure Power is not an authorised medicinal product, and we therefore warn consumers not to use the product. We advise consumers who have taken Viamax Pure Power to stop using it and to contact their doctor if they have any concerns. The illegal medicinal product may be handed over to a pharmacy for destruction.

Danish Medicines Agency

5-1-2012

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N02A, opioids, as well as certain medicines in ATC groups N07BC and R05DA.

Danish Medicines Agency

20-9-2011

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

The Reimbursement Committee’s recommendation on the future reimbursement status of glucosamine-containing medicines was open for consultation until 8 August 2011. The Danish Medicines Agency received 4 consultation responses.

Danish Medicines Agency

20-9-2011

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

The Reimbursement Committee’s recommendation on the future reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B was open for consultation until 15 August 2011. The Danish Medicines Agency received 9 consultation responses.

Danish Medicines Agency

5-7-2011

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group C01 – cardiac therapy. These medicines are used for the treatment of cardiac arrhythmia (e.g. atrial fibrillation) and heart cramps (angina pectoris).

Danish Medicines Agency

20-6-2011

Warning against the tanning product Melanotan

Warning against the tanning product Melanotan

The Danish Medicines Agency repeats its warning against using the illegal product Melanotan because its effect is not documented and because of the absence of studies of its potential side effects. The Danish Medicines Agency urges everyone who uses Melanotan to stop using it and to contact their doctor if concerned.

Danish Medicines Agency

6-5-2011

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (medicines in ACT group N06A, etc.)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (medicines in ACT group N06A, etc.)

At the Danish Medicines Agency’s request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B.

Danish Medicines Agency

14-6-2010

Change of the reimbursement for certain cardiovascular products as of 15 November 2010

Change of the reimbursement for certain cardiovascular products as of 15 November 2010

The Reimbursement Committee and the Danish Medicines Agency have reviewed some of the medicinal products used for the treatment of cardiovascular disease (antihypertensives) in order to assess whether they meet the criteria for public reimbursement. The medicinal products concerned are the so-called angiotensin II antagonists and renin inhibitors.

Danish Medicines Agency

3-6-2010

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors) was open for consultation until 7 May 2010.

Danish Medicines Agency

9-4-2010

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders) was open for consultation until 15 March 2010.

Danish Medicines Agency

31-3-2010

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

17-12-2009

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders).

Danish Medicines Agency

2-10-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C05 (Vasoprotectives)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C05 (Vasoprotectives)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C05 (Vasoprotectives).

Danish Medicines Agency

30-6-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C04 (Peripheral vasodilators)

Danish Medicines Agency

30-6-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups A04 (antiemetics and antinauseants) and A03FA (propulsives)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups A04 (antiemetics and antinauseants) and A03FA (propulsives)

At the Danish Medicines Agency’s request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC groups A04 (antiemetics and antinauseants) and A03FA (propulsives).

Danish Medicines Agency

30-4-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A08 (antiobesity preparations, excl. diet products)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A08 (antiobesity preparations, excl. diet products)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group A08 (antiobesity preparations, excl. diet products).

Danish Medicines Agency

21-11-2008

Consultation responses on the future reimbursement status of medicinal products for cardiovascular diseases

Consultation responses on the future reimbursement status of medicinal products for cardiovascular diseases

The Reimbursement Committee’s additional recommendation concerning the future reimbursement status of medicinal products for cardiovascular diseases in ATC groups C02, C03, C07, C08 and C09 (antihypertensives) was submitted for consultation with 19 September 2008 as the consultation deadline

Danish Medicines Agency

24-4-2006

Letter to scientific societies on treatment of hypertension

Letter to scientific societies on treatment of hypertension

As part of the reassessment concerning medicinal products' reimbursement status, the Danish Medicines Agency has begun looking at reimbursement status of medicinal products for hypertension.

Danish Medicines Agency

22-8-2018

News and press releases:  Keeping medicines safe

News and press releases: Keeping medicines safe

How EMA monitors medicines once they are on the market

Europe - EMA - European Medicines Agency

21-8-2018

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months!  https://go.usa.gov/xUskq 
#OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCare pic.twitter.com/VRDkVPvMTR

FDA - U.S. Food and Drug Administration

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

15-8-2018

Concerta® 27 mg Retardtabletten

Rote - Liste

22-7-2018

As the #FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns.  https://www.fda.gov/NewsEvents

As the #FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns. https://www.fda.gov/NewsEvents

As the #FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm …

FDA - U.S. Food and Drug Administration

22-7-2018

Once on market, #FDA monitors for safety issues by collecting adverse event reports  https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t prov

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t prov

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t provide real-time information pic.twitter.com/WJMYVcAyoQ

FDA - U.S. Food and Drug Administration