Program Plus LL ad us. vet.

Hauptinformation

  • Handelsname:
  • Program® Plus LL ad us. vet., Filmtabletten
  • Darreichungsform:
  • Filmtabletten
  • Verwenden für:
  • Tiere
  • 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:
  • Program® Plus LL ad us. vet., Filmtabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Antiparasitikum für Hunde

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 56062
  • Letzte Änderung:
  • 02-09-2017

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Program

Plus LL ad us. vet., Filmtabletten

Elanco Tiergesundheit AG

Antiparasitikum für Hunde

ATCvet: QP54AB51

Zusammensetzung

1 Filmtablette Program Plus LL 23 mg/460 mg enthält:

Milbemycin-Oxim je Tablette23 mg

Lufenuron je Tablette

460 mg

Farbe der Schachtel

Weiss

Fachinformationen Wirkstoffe (CliniPharm)

Lufenuron - Milbemycinoxim

Eigenschaften / Wirkungen

Milbemycin gehört zu der Gruppe von makrozyklischen Lactonen, welche aus der

Fermentation mit Streptomyces hygroscopius var. aureolacrimosus isoliert werden. Von

den ausgewählten Analogen wird Milbemycin-Oxim A3/A4 (Verhältnis ≤ 20: ≥ 80) derzeit

für therapeutische Zwecke eingesetzt. Als eine der Aktivsubstanzen in Program Plus zeigt

es eine optimale Wirkung gegen die larvalen Stadien (L3, L4 und Mikrofilarien) von

Dirofilaria immitis sowie anthelminthische Aktivität gegen die folgenden Nematoden:

Toxocara canis, Trichuris vulpis, Ancylostoma caninum. Die Wirksamkeit von Milbemycin

ist korreliert mit seiner Wirkung auf die Neurotransmission bei Wirbellosen: Es potenziert

GABA (Gamma-Amino-Buttersäure) als Hemmstoff der Neurotransmission und führt so

zur Paralyse.

Lufenuron gehört zur Gruppe der Benzoyl-Harnstoffe und gilt als IGR

(Insektenwachstumsregulator) bzw. als IDI (Insektenentwicklungshemmer). Es unterbricht

den Entwicklungszyklus von Flöhen indem es mit der normalen Synthese, Polymerisation

und Ablagerung von Chitin, dem Hauptbestandteil des Aussenskeletts von Insekten,

interferiert. Der adulte Floh nimmt Lufenuron mit der Blutmahlzeit auf. In therapeutischen

Dosen besitzt Lufenuron keine Wirkung gegen adulte Flöhe. Aber es gelangt mittels trans-

ovarieller Passage zu Floheiern und Larven, d.h. zu den Entwicklungsstadien, bei denen

es wirkt und unterbricht so den Entwicklungszyklus. Zusätzlich enthält Flohkot Lufenuron

und besitzt somit larvizide Wirkung bei direkter Ingestion durch Flohlarven.

Pharmakokinetik

Milbemycin-Oxim wird gut aus dem Gastrointestinal-Trakt absorbiert. Spitzen-

Plasmakonzentrationen von etwa 200 - 300 ng/ml werden innerhalb von 2 bis 5 Stunden

nach oraler Verabreichung in der empfohlenen Dosis erreicht. Danach nehmen die

Plasmakonzentrationen von Milbemycin-Oxim mit einer Halbwertszeit von 1 bis 3 Tagen

Nach oraler Verabreichung gelangt Lufenuron über den Blutkreislauf ins Fettgewebe. Von

dort wird es kontinuierlich in metabolisch unveränderter Form in minimal wirksamer

Konzentration für mindestens 1 Monat wieder freigesetzt.

Indikationen

Zur gleichzeitigen Vorbeugung und Kontrolle eines Flohbefalls (Bekämpfung der

präadulten Stadien von Ct. felis; Ct. canis), und/oder Behandlung von gastrointestinalen

Nematoden (adulte Stadien) wie Hakenwurm (Ancylostoma caninum), Spulwurm

(Toxocara canis) oder Peitschenwurm (Trichuris vulpis) sowie Herzwurmprophylaxe

(Elimination des 3. und 4. Larvenstadiums von Dirofilaria immitis) beim Hund.

Dosierung / Anwendung

Die empfohlene Dosierung von Program Plus beträgt mindestens 0,5 mg Milbemycin-Oxim

und 10 mg Lufenuron pro kg Körpergewicht. Program Plus Tabletten werden

entsprechend dem Körpergewicht des Hundes verabreicht (vgl. Tabelle).

Dosisstärke

Körpergewicht

Dosierung

pro Monat

Program

Plus

5.75 mg / 115 m

5 - 11 kg

1 Tablette

Program

Plus

11.5 mg / 230 m

12 - 22 kg

1 Tablette

Program

Plus

23 mg / 460 mg

23 - 45 kg

1 Tablette

Program Plus Tabletten sind in den folgenden Fällen zu verabreichen:

Welpen:

Zur gleichzeitigen Vorbeugung eines Flohbefalls, einer Herzwurmerkrankung und/oder

einer gastrointestinalen Nematodeninfektion sollte die Behandlung von Welpen ab einem

Alter von 2 Wochen oder ab einem Mindestgewicht von 1 kg beginnen.

Hunde ausserhalb von Herzwurmendemiegebieten:

Program Plus kann im Rahmen der Vorbeugung des saisonalen Flohbefalls anstelle von

Program

eingesetzt werden, wenn gleichzeitig eine Infektion mit Magendarm-Nematoden

nachgewiesen wird. Nach erfolgreicher Elimination der Nematoden, was durch eine

Kotuntersuchung bestätigt werden sollte, kann im Bedarfsfall die Vorbeugung gegen

Flohbefall mit Program fortgesetzt werden.

Bei Welpen empfiehlt es sich, die Behandlung mit Program Plus bis zu 4 Wochen nach

dem Absetzen weiterzuführen. Anschliessend kann die Vorbeugung des Flohbefalls mit

Program fortgesetzt werden.

Hunde, die in Herzwurmgebiete verbracht werden:

Zur gleichzeitigen Vorbeugung des Flohbefalls und der Herzwurmerkrankung sollte die

Behandlung innerhalb von 4 Wochen nach der Ankunft begonnen werden. Die

Behandlung ist monatlich fortzuführen, wobei die letzte Verabreichung nach Verlassen der

Region erfolgen soll.

Hunde in Herzwurmgebieten:

Zur gleichzeitigen Vorbeugung des Flohbefalls und der Herzwurmerkrankung sollte die

Behandlung innerhalb von 4 Wochen nach dem Erscheinen der Mücken bzw. einen Monat

vor Beginn der Flohsaison begonnen werden. Sie ist bis zum Ende der Periode mit

Ansteckungsgefahr fortzusetzen, wobei die letzte Verabreichung innerhalb von 4 Wochen

nach Ende der Mücken- bzw. Flohsaison erfolgen soll. Falls Hunde bei

Behandlungsbeginn einen starken Flohbefall aufweisen, kann es notwendig sein, zu

Beginn der Behandlung ein Adultizid einzusetzen.

Es ist wichtig, dass alle Hunde und Katzen des Haushaltes gegen Flöhe behandelt

werden. Katzen im selben Haushalt sollten mit einem spezifischen antiparasitären

Präparat behandelt werden.

Die beste Wirksamkeit erhält man, indem die Tabletten mit oder sofort nach einer vollen

Mahlzeit - in einem Leckerbissen versteckt oder durch direkte Eingabe - verabreicht

werden.

Wenn möglich, sollte die Verabreichung immer am gleichen Wochentag des Monats

erfolgen.

Ist ein Behandlungsintervall grösser als 6 Wochen, so ist mit der Verabreichung sofort

wieder zu beginnen und in monatlichen Abständen fortzuführen. In Fällen der

Herzwurmprävention ist das weitere Vorgehen mit einem Tierarzt abzusprechen.

Anwendungseinschränkungen

Kontraindikationen:

keine bekannt.

Vorsichtsmassnahmen:

Studien mit Milbemycin-Oxim weisen darauf hin, dass die therapeutische Breite bei

Hunden mit MDR1-Mutation kleiner ist als bei anderen Rassen. Bei diesen Hunden sollte

die empfohlene Dosierung von 0.5 mg/kg Körpergewicht strikt eingehalten werden. Die

klinischen Erscheinungen bei Rassen mit dem MDR1-Defekt ähneln denen, die in der

allgemeinen Hundepopulation bei Überdosierung beobachtet wurden. Die Verträglichkeit

des Tierarzneimittels wurde nicht bei jungen Welpen von Rassen mit dem MDR1-Defekt

untersucht.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

Blasse Schleimhäute und eine erhöhte intestinale Peristaltik wurden bei einigen Hunden

nach der Behandlung beobachtet. Werden Hunde behandelt, bei denen eine grosse

Anzahl zirkulierender Mikrofilarien festgestellt wurde, können gelegentlich mässige und

vorübergehende Überempfindlichkeitsreaktionen, wie blasse Schleimhäute, Erbrechen,

Atembeschwerden oder übermässiges Speicheln auftreten. Diese Reaktionen beruhen auf

der Freisetzung von Eiweiss aus toten oder absterbenden Mikrofilarien und werden nicht

durch das Arzneimittel ausgelöst.

Wechselwirkungen

Keine bekannt.

Sonstige Hinweise

Program Plus ist für Kinder unerreichbar und nicht über 25°C zu lagern. Das Medikament

darf nur bis zu dem auf der Packung mit "EXP" bezeichneten Datum verwendet werden.

Packungen

Program Plus LL 23 mg/460 mg:

Schachteln mit 6 Filmtabl.

Abgabekategorie: B

Swissmedic Nr. 56'062

Informationsstand: 10/2012

Dieser Text ist behördlich genehmigt.

18-1-2019

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Published on: Thu, 17 Jan 2019 Open government data are about wide and free availability of public information created or collected by public entities. The International Open Data Charter and Findable, Accessible, Interoperable And Reusable Data (FAIR) data principles were selected as the guiding principles for the development of this report. A review of open data maturity reports indicated that most of the EU28+ are making significant progress in open government data, however there are different levels...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019

Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019

On 1 January 2019, a special reimbursement scheme for medicinal cannabis in the four-year pilot programme entered into force. Reimbursement is retroactive for purchases made in 2018.

Danish Medicines Agency

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-1-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications.

FDA - U.S. Food and Drug Administration

21-12-2018

National Research Programme for Environmental and Occupational Health:  43 projects selected and €7.4 million mobilised  for the 2018 calls for projects

National Research Programme for Environmental and Occupational Health: 43 projects selected and €7.4 million mobilised for the 2018 calls for projects

Today, ANSES is publishing the list of projects selected as part of its two 2018 calls for research projects for the National Research Programme for Environmental and Occupational Health: the first for projects on a general theme, and the second on the theme of "radiofrequencies and health". Following the selection process, 43 projects were selected with funding amounting to a total of 7.4 million euros.

France - Agence Nationale du Médicament Vétérinaire

21-12-2018

Ampi-Kur ad us. vet., Eutersuspension

Ampi-Kur ad us. vet., Eutersuspension

● Die Zulassung ist am 21.12.2018 erloschen.

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Workshop on Avian Influenza

Workshop on Avian Influenza

Published on: Wed, 19 Dec 2018 Since September 2017, EFSA has been providing ongoing scientific and technical support to the European Commission and Member States (MSs) in the collection, collation, and analysis of epidemiological data relevant to the monitoring of avian influenza (AI) viruses in Europe and third countries. From 2019 onwards, EFSA will also be responsible for collecting, collating, and analysing the data gathered by MSs via their surveillance programmes in poultry and wild birds. To eff...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Versican Plus DHPPi/L4 ad us. vet.

Versican Plus DHPPi/L4 ad us. vet.

● Änderung Text "Kurzbezeichnung", "Zusammensetzung", "Indikation", "Dosierung / Anwendung", "Anwendungseinschränkungen", "Unerwünschte Wirkungen", "Wechselwirkungen", "Sonstige Hinweise" und "Packungen"

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Versican Plus DHPPi/L4R ad us. vet.

Versican Plus DHPPi/L4R ad us. vet.

● Änderung Text "Zusammensetzung", "Indikation", "Dosierung / Anwendung", "Anwendungseinschränkungen", "Unerwünschte Wirkungen", "Wechselwirkungen", "Sonstige Hinweise" und "Packungen"

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Versican Plus L4 ad us. vet.

Versican Plus L4 ad us. vet.

● Änderung Text "Eigenschaften", "Dosierung / Anwendung", "Anwendungseinschränkungen", "Unerwünschte Wirkungen", "Wechselwirkungen" und "Sonstige Hinweise"

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Versican Plus Pi/L4 ad us. vet.

Versican Plus Pi/L4 ad us. vet.

● Änderung Text "Kurzbezeichnung", "Zusammensetzung", "Indikationen", "Dosierung / Anwendung", "Anwendungseinschränkungen", "Unerwünschte Wirkungen" und "Wechselwirkungen"

Institut für Veterinärpharmakologie und toxikologie

20-12-2018

Perlutex ad us. vet., Tabletten

Perlutex ad us. vet., Tabletten

● Änderung Text "Zusammensetzung", "Dosierung / Anwendung" und "Sonstige Hinweise"

Institut für Veterinärpharmakologie und toxikologie

19-12-2018

CLS Sales Inc. recalls Wood Pull Back Plane

CLS Sales Inc. recalls Wood Pull Back Plane

Health Canada's sampling and evaluation program has determined that this toy does not meet the Canadian safety requirements for toys. More specifically, the tail fin and/or propeller may break off the toy, posing a choking hazard to young children.

Health Canada

18-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety

FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).

FDA - U.S. Food and Drug Administration

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Schauma-Dip ad us. vet., Zitzendesinfektionsmittel

Schauma-Dip ad us. vet., Zitzendesinfektionsmittel

● Neue Zulassungsinhaberin: Halag Chemie AG

Institut für Veterinärpharmakologie und toxikologie

14-12-2018

Bovilis BTV8 ad us. vet.

Bovilis BTV8 ad us. vet.

● Die Zulassung ist am 14.12.2018 erloschen.

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

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

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

Published on: Tue, 11 Dec 2018 The main goal of the Framework Partnership Agreement project is to put in place a relevant organisation in order to improve gathering, checking, storage and providing of data from national monitoring programs to EFSA. By accepting to participate in the pilot project, France has committed to implement several enhancement actions on the overall system of data collection and submission. This report describes the results of the implementations of these measures and presents th...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

Activyl TickPlus spot-on Hund XS ad us. vet., insektizide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund XS ad us. vet., insektizide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Activyl TickPlus spot-on Hund S ad us. vet., insektizide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund S ad us. vet., insektizide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Activyl TickPlus spot-on Hund M ad us. vet., insektizide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund M ad us. vet., insektizide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Activyl TickPlus spot-on Hund L ad us. vet., insektiztide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund L ad us. vet., insektiztide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Activyl TickPlus spot-on Hund XL ad us. vet., insektizide Loesung zum Auftragen auf die Haut

Activyl TickPlus spot-on Hund XL ad us. vet., insektizide Loesung zum Auftragen auf die Haut

● Umwandlung in Exportzulassung (Exportspezialität): nur für den Vertrieb im Ausland

Institut für Veterinärpharmakologie und toxikologie

12-12-2018

Carofertin ad us. vet., Injektionsemulsion

Carofertin ad us. vet., Injektionsemulsion

● Die Neuzulassung erfolgte am 12.12.2018.

Institut für Veterinärpharmakologie und toxikologie

11-12-2018

Simparica 5 mg ad us. vet., Kautabletten fuer Hunde

Simparica 5 mg ad us. vet., Kautabletten fuer Hunde

● Indikationserweiterung (Demodex canis, Otodectes cynotis) ● Änderung Text "Eigenschaften / Wirkungen", "Indikationen", "Dosierung / Anwendung" und "Unerwünschte Wirkungen"

Institut für Veterinärpharmakologie und toxikologie

11-12-2018

Simparica 10 mg ad us. vet., Kautabletten fuer Hunde

Simparica 10 mg ad us. vet., Kautabletten fuer Hunde

● Indikationserweiterung (Demodex canis, Otodectes cynotis) ● Änderung Text "Eigenschaften / Wirkungen", "Indikationen", "Dosierung / Anwendung" und "Unerwünschte Wirkungen"

Institut für Veterinärpharmakologie und toxikologie

11-12-2018

Simparica 20 mg ad us. vet., Kautabletten fuer Hunde

Simparica 20 mg ad us. vet., Kautabletten fuer Hunde

● Indikationserweiterung (Demodex canis, Otodectes cynotis) ● Änderung Text "Eigenschaften / Wirkungen", "Indikationen", "Dosierung / Anwendung" und "Unerwünschte Wirkungen"

Institut für Veterinärpharmakologie und toxikologie

11-12-2018

Simparica 40 mg ad us. vet., Kautabletten fuer Hunde

Simparica 40 mg ad us. vet., Kautabletten fuer Hunde

● Indikationserweiterung (Demodex canis, Otodectes cynotis) ● Änderung Text "Eigenschaften / Wirkungen", "Indikationen", "Dosierung / Anwendung" und "Unerwünschte Wirkungen"

Institut für Veterinärpharmakologie und toxikologie

11-12-2018

Simparica 80 mg ad us. vet., Kautabletten fuer Hunde

Simparica 80 mg ad us. vet., Kautabletten fuer Hunde

● Indikationserweiterung (Demodex canis, Otodectes cynotis) ● Änderung Text "Eigenschaften / Wirkungen", "Indikationen", "Dosierung / Anwendung" und "Unerwünschte Wirkungen"

Institut für Veterinärpharmakologie und toxikologie

11-12-2018

Simparica 120 mg ad us. vet., Kautabletten fuer Hunde

Simparica 120 mg ad us. vet., Kautabletten fuer Hunde

● Indikationserweiterung (Demodex canis, Otodectes cynotis) ● Änderung Text "Eigenschaften / Wirkungen", "Indikationen", "Dosierung / Anwendung" und "Unerwünschte Wirkungen"

Institut für Veterinärpharmakologie und toxikologie

11-12-2018

Zulvac 8 Bovis ad us. vet., Suspension zur Injektion fuer Rinder

Zulvac 8 Bovis ad us. vet., Suspension zur Injektion fuer Rinder

● Änderung Text gesamte Arzneimittelinformation

Institut für Veterinärpharmakologie und toxikologie

10-12-2018

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder

FDA - U.S. Food and Drug Administration

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

Hyalovet 20 ad us. vet., Injektionsloesung

Hyalovet 20 ad us. vet., Injektionsloesung

● Zusätzliche Applikationsart: intravenöse Anwendung

Institut für Veterinärpharmakologie und toxikologie

6-12-2018

Milteforan 20 mg/ml ad us. vet., orale Loesung

Milteforan 20 mg/ml ad us. vet., orale Loesung

● Änderung Text "Dosierung / Anwendung" (Verschlusssystem) und "Unerwünschte Wirkungen"

Institut für Veterinärpharmakologie und toxikologie

6-12-2018

Ubroseal ad us. vet., intramammaere Suspension

Ubroseal ad us. vet., intramammaere Suspension

● Die Neuzulassung erfolgte am 06.12.2018.

Institut für Veterinärpharmakologie und toxikologie

4-12-2018

Arnica compositum ad us. vet., Tabletten

Arnica compositum ad us. vet., Tabletten

● Die Neuzulassung erfolgte am 04.12.2018.

Institut für Veterinärpharmakologie und toxikologie

30-11-2018

Reporting Avian Influenza surveillance

Reporting Avian Influenza surveillance

Published on: Thu, 29 Nov 2018 Avian influenza viruses infect domestic poultry and wild birds as well as humans. In poultry, depending on whether these viruses are of high pathogenicity (HPAI) or low pathogenicity (LPAI), the infection can cause different clinical signs, with HPAI causing high mortality in poultry flocks. In order to ensure early detection of avian influenza viruses, surveillance in poultry and wild birds is considered essential. In 2010, the European Commission provided some guidelines...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

CLS Sales Inc. recalls Wind Up Fish & Lion Toys

CLS Sales Inc. recalls Wind Up Fish & Lion Toys

Health Canada’s sampling and evaluation program has determined that the toys do not meet the Canadian safety requirements for toys. Additionally, the fish toy released small parts during testing, which could pose as a choking hazard for young children.

Health Canada

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

11-1-2019

Consultation: Good Clinical Practice Inspections Program

Consultation: Good Clinical Practice Inspections Program

The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019

Therapeutic Goods Administration - Australia

20-12-2018

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here:  https://go.usa.gov/

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/

. @US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB  #MedicalDevice

FDA - U.S. Food and Drug Administration

20-12-2018


Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Europe - EMA - European Medicines Agency

19-12-2018

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar:  https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDA pic.twitter.com/sHElqFFODy

FDA - U.S. Food and Drug Administration

19-12-2018

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.

FDA - U.S. Food and Drug Administration

19-12-2018

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more:  https

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more: https

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more: https://go.usa.gov/xExHq  pic.twitter.com/fAAZAQx1H5

FDA - U.S. Food and Drug Administration

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

18-12-2018

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers:  https://go.usa.gov/xEx2r  #FDApic.twitter.com/57pZAmSb9r

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDApic.twitter.com/57pZAmSb9r

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDA pic.twitter.com/57pZAmSb9r

FDA - U.S. Food and Drug Administration

18-12-2018


Committee for Advanced Therapies (CAT) work programme 2019

Committee for Advanced Therapies (CAT) work programme 2019

Committee for Advanced Therapies (CAT) work programme 2019

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2112 (Merck Europe B.V.)

EU/3/18/2112 (Merck Europe B.V.)

EU/3/18/2112 (Active substance: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1) - Orphan designation - Commission Decision (2018)9027 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/154/18

Europe -DG Health and Food Safety

14-12-2018

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here:  https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/X4IprwU8R2

FDA - U.S. Food and Drug Administration

14-12-2018

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here:  https://go.usa.gov/xE3ke  #FDA #MedicalDevice

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

10-12-2018

.@US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more:  https://go.usa.gov/xPShF  #MedicalDevice #FDApic.twitter.com/HiJbgPnsPt

.@US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF  #MedicalDevice #FDApic.twitter.com/HiJbgPnsPt

. @US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF  #MedicalDevice #FDA pic.twitter.com/HiJbgPnsPt

FDA - U.S. Food and Drug Administration

2-12-2018

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts pic.twitter.com/2co2Hz4jUt

FDA - U.S. Food and Drug Administration

1-12-2018

.@US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation.  https://ja.ma/2rdAtre pic.twitter.com/XiTbPfEkcj

.@US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation. https://ja.ma/2rdAtre pic.twitter.com/XiTbPfEkcj

. @US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation. https://ja.ma/2rdAtre  pic.twitter.com/XiTbPfEkcj

FDA - U.S. Food and Drug Administration

30-11-2018

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of  blood glucose monitors to empower patients with diabetes with reliable  tools to manage their health. Read more:  https://go.usa.gov/xPMyA   #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall:  https://go.usa.gov/xPMEn  #MedicalDevicepic.twitter.com/YU9Iq

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevicepic.twitter.com/YU9Iq

. @US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevice pic.twitter.com/YU9Iq3Yw0b

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer  Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack  of Adequate Validation and Controls to Ensure Product Cleanliness. Read  more about the recall:  https://go.us

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.us

. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

.@US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

. @US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

FDA - U.S. Food and Drug Administration

28-11-2018

Listed medicine compliance rating scheme

Listed medicine compliance rating scheme

We have implemented a Compliance Rating Scheme for listed medicines as part of ongoing enhancements to our post-market compliance monitoring program

Therapeutic Goods Administration - Australia

26-11-2018

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do:  https://go.usa.gov/xPHtk   #FDA #MedicalDevice

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

26-11-2018

The 510(k) program has been strengthened and refined in many ways, especially in recent years, as the FDA’s Device Center has made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety.

The 510(k) program has been strengthened and refined in many ways, especially in recent years, as the FDA’s Device Center has made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety.

The 510(k) program has been strengthened and refined in many ways, especially in recent years, as the FDA’s Device Center has made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety.

FDA - U.S. Food and Drug Administration