Co-Diovan 320/12

Hauptinformation

  • Handelsname:
  • Co-Diovan 320/12 5, Filmtabletten
  • Darreichungsform:
  • 5, Filmtabletten
  • Zusammensetzung:
  • valsartanum 320 mg, hydrochlorothiazidum 12.5 mg, excipiens pro compresso Dunst.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Co-Diovan 320/12 5, Filmtabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Hypertonie

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 54470
  • Berechtigungsdatum:
  • 28-01-1998
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage

Patienteninformation

Co-Diovan®

Novartis Pharma Schweiz AG

Was ist Co-Diovan und wann wird es angewendet?

Co-Diovan enthält zwei sich ergänzende Wirksubstanzen, die das blutdruckregulierende System des

Körpers beeinflussen: Valsartan, das in erster Linie zu einer Erweiterung der Blutgefässe führt und

damit den Blutdruck senkt, und Hydrochlorothiazid, welches den Natriumchlorid- und Wassergehalt

im Körper vermindert, indem es die Urinausscheidung erhöht.

Co-Diovan wird zur Behandlung des leichten und mittelschweren Bluthochdrucks eingesetzt, bei

Patienten, deren Bluthochdruck ein Kombinationspräparat erfordert.

Ihr Arzt oder Ihre Ärztin kann die Wirkung mittels Blutdruckmessung kontrollieren und nachweisen.

Co-Diovan darf nur auf Verschreibung des Arztes oder der Ärztin angewendet werden.

Was sollte dazu beachtet werden?

Wieso sollte ein hoher Blutdruck (Hypertonie) behandelt werden?

Wenn ein hoher Blutdruck nicht behandelt wird, können lebenswichtige Organe wie das Herz, die

Nieren und das Hirn geschädigt werden. Sie können sich wohl fühlen und keine Symptome haben,

aber die unbehandelte Hypertonie kann zu Spätfolgen wie z.B. Hirnschlag, Herzinfarkt,

Herzschwäche, Nierenfunktionsstörungen oder Erblinden führen.

Wann darf Co-Diovan nicht angewendet werden?

Sie dürfen Co-Diovan nicht einnehmen, wenn Sie jemals überempfindlich oder allergisch auf

Valsartan, Hydrochlorothiazid oder einen anderen Bestandteil dieses Arzneimittels reagiert haben.

Wenn Sie schwanger sind, planen schwanger zu werden oder stillen, oder wenn Sie an einer

Zerstörung der kleinen Gallengänge innerhalb der Leber (biliäre Zirrhose), die zu Gallenstauung

führt leiden, wenn Sie an Diabetes (Typ 1 und 2) oder eingeschränkter Nierenfunktion leiden,

während Sie den blutdrucksenkenden Wirkstoff Aliskiren einnehmen, oder wenn Sie an stark

verminderter Harnmenge leiden (Anurie), dürfen Sie Co-Diovan nicht einnehmen. Falls Sie an einem

hereditären Angioödem leiden. Falls früher anlässlich der Einnahme eines blutdrucksenkenden

Medikamentes Schwellungen im Gesicht, Lippen, Zunge oder im Rachen (Schluck- oder

Atembeschwerden) auftraten, dürfen Sie Co-Diovan nicht einnehmen.

Wann ist bei der Einnahme von Co-Diovan Vorsicht geboten?

Wie jedes andere blutdrucksenkende Mittel kann auch Co-Diovan Ihre Aufmerksamkeit und

Konzentration herabsetzen. Daher ist Vorsicht im Strassenverkehr und beim Bedienen von

Werkzeugen oder Maschinen geboten.

Vorsicht ist geboten,

·wenn Sie an einer Nieren- oder Lebererkrankung, an Allergien oder Asthma leiden.

·Falls bei Ihnen nach der Einnahme von Co-Diovan Reaktionen wie Schwellung im Gesicht, der

Arme und Beine, Augen, Lippen oder Zunge (Anzeichen eines Angioödem) auftreten. Sie müssen in

diesen Fällen überwacht und eventuell entsprechend behandelt werden.

Ein eventuell bestehender Salz-/Flüssigkeitsmangel - verursacht z.B. durch übermässiges Erbrechen,

Durchfall oder Diuretika (harntreibende Mittel) - ist vor Beginn der Behandlung auszugleichen.

Möglicherweise wird Ihr Arzt bzw. Ihre Ärztin auch Ihre Nierenfunktion überprüfen.

Vorsicht ist geboten, wenn Sie mit einem ACE-Hemmer oder Aliskiren (Arzneimittel gegen

Bluthochdruck) behandelt werden.

Falls bei Ihnen eine plötzliche Abnahme des Sehvermögens oder Augenschmerzen auftreten,

könnten dies Symptome eines erhöhten Druckes in Ihren Augen sein. Dies kann innerhalb von

Stunden bis Wochen nach Behandlungsbeginn von Co-Diovan vorkommen. In diesem Fall

kontaktieren Sie bitte unverzüglich Ihren Arzt.

Wenn Sie an Herzschwäche leiden oder einen Herzinfarkt hatten ist ebenfalls Vorsicht geboten.

Befolgen Sie die ärztliche Anweisung für die Anfangsdosierung sorgfältig. Ihr Arzt bzw. Ihre Ärztin

wird möglicherweise auch Ihre Nierenfunktion überprüfen.

Informieren Sie Ihren Arzt oder Ihre Ärztin vor Beginn der Behandlung mit Co-Diovan wenn Sie an:

·einer leichten bis mittelschweren Nieren- oder Lebererkrankung,

·einem akuten Hautausschlag (Lupus erythematodes),

·Hyperurikämie, Gicht oder Diabetes (Zuckerkrankheit),

·zu tiefem Blut-Kalium- oder Natriumspiegel, oder zu hohem Blut Kalziumspiegel, leiden oder

einmal gelitten haben.

Wechselwirkungen mit anderen Arzneimitteln

Bei gleichzeitiger Anwendung von Co-Diovan mit anderen Arzneimitteln kann es zu

Wechselwirkungen kommen (Verstärkung oder Abschwächung der Wirkung von Co-Diovan oder

des anderen Arzneimittels oder vermehrte Nebenwirkungen). Dazu gehören: Kaliumhaltige

Arzneimittel, kaliumhaltige Salzersatzmittel oder andere Arzneimittel, die das Kalium im Blut

erhöhen können (z.B. Heparin zur Blutverdünnung). Ihr Arzt bzw. Ihre Ärztin wird möglicherweise

die Menge an Kalium im Blut periodisch überprüfen; Entzündungs- und Schmerzmittel (sogenannte

nicht-steroidale Antirheumatika einschliesslich COX-2 Hemmer), Lithium (ein Arzneimittel zur

Behandlung gewisser psychischer Erkrankungen), wasserausschwemmende Arzneimittel, ACE-

Hemmer oder Aliskiren, kortisonartige Arzneimittel (Steroide), Antiarrhythmika (zur Behandlung

von Herzrhythmusstörungen), gewisse Arzneimittel zur Behandlung von Infektionen (Amphotericin

B, Penicillin G, Rifamycin-Gruppe), andere blutdrucksenkende Arzneimittel, Digoxin oder andere

Digitalis-Glykoside (Herzmittel), Insulin oder antidiabetische Arzneimittel zum Einnehmen,

Allopurinol (Gichtmittel), Amantadin (zur Behandlung der Parkinson-Krankheit, auch bei gewissen

Virus-Erkrankungen), gewisse Krebs-Arzneimittel, anticholinerge Wirkstoffe (zur Behandlung

verschiedener Störungen wie z.B. Magen-Darm-Krämpfe, Krämpfe der Harnblase, Asthma,

Reisekrankheit, Muskelkrämpfe, Parkinson-Krankheit und als Hilfsmittel zur Narkose),

Colestyramin, Colestipol und andere Harze (zur Behandlung hoher Blutfette), muskelentspannende

Arzneimittel, Vitamin D und Kalziumsalze, Ciclosporin (zur Verhinderung der Organabstossung

nach Transplantation oder bei anderen Krankheiten wie rheumatoide Arthritis oder Neurodermitis),

Ritonavir (antiretrovirales Arzneimittel zur Behandlung von HIV/AIDS Infektionen), Arzneimittel

gegen Epilepsie wie Carbamazepin, Diazoxid (Bluthochdruck oder zu tiefem Blutzucker), Lithium,

Antidepressiva, Antipsychotika (zur Behandlung bestimmter psychiatrischer Störungen),

blutdrucksteigernde Amine (wie Noradrenalin), Barbiturate, Narkotika (einschläfernde Mittel) und

Alkohol.

Teilen Sie Ihrem Arzt bzw. Ihrer Ärztin mit, wenn Sie andere Arzneimittel anwenden. Er bzw. sie

wird entscheiden, welches Arzneimittel Sie gleichzeitig mit Co-Diovan anwenden können, und

eventuell die Dosis eines der Arzneimittel anpassen.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie

·an anderen Krankheiten leiden,

·Allergien haben oder

·andere Arzneimittel (auch selbstgekaufte!) einnehmen, kürzlich eingenommen haben oder

äusserlich anwenden.

Darf Co-Diovan während einer Schwangerschaft oder in der Stillzeit eingenommen werden?

Sie dürfen Co-Diovan nicht einnehmen, wenn Sie schwanger sind oder planen, schwanger zu

werden.

Ähnliche Arzneimittel wurden mit schweren Schädigungen des ungeborenen Kindes in Verbindung

gebracht, vor allem, wenn sie nach dem dritten Schwangerschaftsmonat eingenommen werden. Für

Co-Diovan liegen zurzeit noch keine Erfahrungen vor. Deshalb ist es wichtig, dass Sie sofort Ihren

Arzt oder Ihre Ärztin aufsuchen, wenn Sie glauben, Sie könnten schwanger sein. Informieren Sie

Ihren Arzt oder Ihre Ärztin auch, wenn Sie eine Schwangerschaft planen.

Ist eine Behandlung während der Stillzeit erforderlich, sollte abgestillt werden.

Wie verwenden Sie Co-Diovan?

Ihr Arzt oder Ihre Ärztin entscheidet über die für Sie richtige Dosierung.

Die übliche Dosierung beträgt einmal täglich 1 Filmtablette Co-Diovan 80/12.5 (entspricht 80 mg

Valsartan und 12.5 mg Hydrochlorothiazid). Bei ungenügender Blutdrucksenkung nach 3-4 Wochen

Behandlung, kann zunächst auf Co-Diovan 160/12.5 (entspricht 160 mg Valsartan und 12.5 mg

Hydrochlorothiazid) und dann anschliessend auf Co-Diovan 160/25 (entspricht 160 mg Valsartan

und 25 mg Hydrochlorothiazid) erhöht werden.

Die Dosierung ist unabhängig vom Alter. Die Wirksamkeit und Sicherheit der Behandlung bei

Kindern und Jugendlichen unter 18 Jahren wurden jedoch nicht überprüft. Deshalb ist die

Anwendung von Co-Diovan bei Kindern und Jugendlichen nicht empfohlen.

Co-Diovan wird mit Flüssigkeit eingenommen. Die Einnahme kann unabhängig von einer Mahlzeit

erfolgen. Es empfiehlt sich jedoch, Co-Diovan täglich zur selben Zeit (z.B. morgens) einzunehmen.

Haben Sie einmal eine Einnahme vergessen, nehmen Sie die nächste Dosis zur üblichen Zeit ein.

Verdoppeln Sie die Dosis nicht!

Unterbrechen Sie nicht von sich aus die Behandlung, ohne dass Ihr Arzt dies angeordnet hat.

Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel

wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder Apotheker bzw. Ihrer Ärztin

oder Apothekerin.

Welche Nebenwirkungen kann Co-Diovan haben?

Folgende Nebenwirkungen können bei der Einnahme von Co-Diovan auftreten:

Zu den häufiger genannten unerwünschten Wirkungen gehören Kopfschmerzen, Müdigkeit,

Benommenheit, Blutdruckabfall beim Aufstehen, Husten, Schnupfen, Entzündung des Rachens,

Infektionen der oberen Atemwege, Appetitlosigkeit, Durchfall, Hautausschlag, Rückenschmerzen,

Gelenkschmerzen, Impotenz.

Gelegentlich wurden Virusinfektionen, Fieber, Kraftlosigkeit, Schwindel, Schlaflosigkeit,

Angstzustände, Sensibilitätsstörungen, Sehstörungen, Mittelohrentzündung, Ohrensausen,

Herzklopfen, schneller Herzschlag, Ödeme, tiefer Blutdruck, übermässiges Schwitzen, Bronchitis,

Atemnot, Entzündung der Nasennebenhöhlen, Halsschmerzen, Mundtrockenheit, Austrocknen,

Bauchschmerzen, Verdauungsstörungen, Übelkeit und Erbrechen, Schmerzen in den Armen, in den

Beinen, im Brustbereich sowie im Nacken, Gelenkentzündung, Verstauchungen und Zerrungen,

Muskelkrämpfe, häufiges Wasserlassen, Harnwegsinfekte oder verminderte Libido genannt.

Selten wurden eine Verschlechterung der diabetischen Stoffwechsellage, Depression, Verstopfung,

Gelbsucht, Lichtempfindlichkeit, Bindehautentzündungen, Sehschwäche oder Schmerzen in den

Augen (hoher Augendruck), Herzrhythmusstörungen, Muskel- oder Nervenschmerzen, stark

verminderte Harnmenge (Nierenerkrankung oder Nierenversagen) beobachtet.

Sehr selten kann es zu Ohnmacht, allergischen Überempfindlichkeitsreaktionen mit Schwellung im

Gesicht, Rötung oder Juckreiz, zu einer Reaktivierung eines kutanen Lupus erythematodes sowie zu

Nierenfunktionsstörungen oder zu Atembeschwerden einschliesslich Lungenentzündung und

Lungenödem sowie zu Nasenbluten oder zu starken Oberbauchschmerzen (Pankreatitis) kommen.

Ferner wurde über Blasenbildung auf der Haut, Muskelkrämpfe und Schwäche (Asthenie) berichtet.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Arzneimittel für Kinder unerreichbar aufbewahren.

Co-Diovan vor Feuchtigkeit geschützt und nicht über 30 °C aufbewahren.

Das Arzneimittel darf nur bis zu dem auf der Packung mit «EXP» bezeichneten Datum verwendet

werden.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in Co-Diovan enthalten?

Co-Diovan 80/12.5 Filmtabletten enthalten die Wirkstoffe Valsartan 80 mg und Hydrochlorothiazid

12.5 mg sowie Hilfsstoffe.

Co-Diovan 160/12.5 Filmtabletten enthalten die Wirkstoffe Valsartan 160 mg und

Hydrochlorothiazid 12.5 mg sowie Hilfsstoffe.

Co-Diovan 160/25 Filmtabletten enthalten die Wirkstoffe Valsartan 160 mg und Hydrochlorothiazid

25 mg sowie Hilfsstoffe.

Zulassungsnummer

54470 (Swissmedic).

Wo erhalten Sie Co-Diovan? Welche Packungen sind erhältlich?

In Apotheken nur gegen ärztliche Verschreibung.

Co-Diovan 80/12.5 Filmtabletten zu 28 und 98.

Co-Diovan 160/12.5 Filmtabletten zu 28 und 98.

Co-Diovan 160/25 Filmtabletten zu 28 und 98.

Zulassungsinhaberin

Novartis Pharma Schweiz AG, Risch; Domizil: 6343 Rotkreuz.

Diese Packungsbeilage wurde im April 2014 letztmals durch die Arzneimittelbehörde (Swissmedic)

geprüft.

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

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Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

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Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

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Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

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Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

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Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

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Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

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FDA - U.S. Food and Drug Administration

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

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Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

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Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

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Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

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Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

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FDA - U.S. Food and Drug Administration

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

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Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

4-10-2018

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

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

Published on: Wed, 03 Oct 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 Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos 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 ethopro...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

21-9-2018

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

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

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

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

13-9-2018

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

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

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

FDA - U.S. Food and Drug Administration

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

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

30-10-2018

SUTENT® 12,5/25/37,5/50 mg Hartkapseln

Rote - Liste

25-10-2018

Moventig® 12,5 mg/25 mg Filmtabletten

Rote - Liste

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

24-9-2018

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Active substance: Choriogonadotrophin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6220 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/320/T/75

Europe -DG Health and Food Safety

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

14-9-2018

Fentanyl AWD® Matrix 12 Mikrogramm/h

Rote - Liste

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

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

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration