Prac-tic M ad us. vet.

Hauptinformation

  • Handelsname:
  • Prac-tic® M ad us. vet., Spot-on Lösung
  • Darreichungsform:
  • Spot-on Lösung
  • 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:
  • Prac-tic® M ad us. vet., Spot-on Lösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Antiektoparasitikum gegen Zecken und Flöhe bei Hunden

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 58037
  • Letzte Änderung:
  • 02-09-2017

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

Prac-tic

M ad us. vet., Spot-on Lösung

Elanco Tiergesundheit AG

Antiektoparasitikum gegen Zecken und Flöhe bei Hunden

ATCvet: QP53AX26

Zusammensetzung

Prac-tic M

Pyriprolum 275 mg

Antiox.: E321

Excipiens ad solutionem pro 2.2 ml

Fachinformationen Wirkstoffe (CliniPharm)

Pyriprol

Eigenschaften / Wirkungen

Prac-tic enthält den Wirkstoff Pyriprol, ein Ektoparasitikum aus der Familie der

Phenylpyrazole. Es bindet an die GABA-Rezeptoren der Nervenzellen und blockiert

dadurch den prä- und post-synaptischen Transfer von Chlorid-Ionen durch die

Zellmembran. Es bewirkt eine unkontrollierte Aktivität des ZNS und führt zu schnellem Tod

von Flöhen und Zecken. Pyriprol tötet Flöhe innerhalb von 24 Stunden und Zecken

innerhalb von 48 Stunden nach Behandlung ab.

Pharmakokinetik

Nach topischer Applikation wird Pyriprol innerhalb eines Tages über das Haarkleid verteilt,

wo es während des gesamten Behandlungsintervalls nachgewiesen werden kann. Die

Verteilung erfolgt innerhalb der Talgschicht der Haut. Pyriprol wird in den Talgdrüsen

gespeichert und von dort langsam wieder freigesetzt. Verteilung, Speicherung und

Wiederfreisetzung sind unabhängig von der Haarlänge. Die Absorption durch die Haut

verläuft sehr langsam, mit einer Absorptionshalbwertszeit von 21 ± 14 Tagen. Aufgrund

der hohen metabolischen Clearance in der Leber können nur die beiden Hauptmetaboliten

im Blut nachgewiesen werden, nicht jedoch die Ausgangssubstanz Pyriprol. Ca. 30 - 45%

der verabreichten Dosis befindet sich nach Applikation zum grössten Teil unverändert

noch in der Haut und in den Haaren.

Indikationen

Zur Therapie und Prophylaxe eines Flohbefalls (Ctenocephalides canis und

Ctenocephalides felis). Prac-tic schützt während mindestens vier Wochen nach

Applikation gegen einen Neubefall mit Flöhen. Geeignet als Teil der Therapie der durch

Flöhe verursachten allergischen Dermatitis (FAD).

Zur Therapie und Prophylaxe eines Zeckenbefalls durch Rhipicephalus sanguineus,

Ixodes ricinus, Ixodes scapularis, Ixodes hexagonus, Dermacentor variabilis, Dermacentor

reticulatus und Amblyomma americanum während eines Monats nach Applikation.

Dosierung / Anwendung

Die empfohlene Mindestdosis für Hunde beträgt 12.5 mg Pyriprol/kg KGW. Dies entspricht

0,1 ml Prac-tic Spot-on Lösung/kg KGW.

Gewicht des Hundes (kg) Pipettengrösse ml der 12,5% Lösung Pyriprol (mg/kg KGW)

2 - 4.5

Prac-tic XS

0.45

12.5 - 28.1

> 4.5 - 11

Prac-tic S

12.5 - 30.6

> 11 - 22

Prac-tic M

12.5 - 25.0

> 22 - 50

Prac-tic L

12.5 - 28.4

> 50

Kombination verschieden grosser Pipetten

Pipettenspitze an der Bruchlinie abbrechen. Pipette vollständig und direkt auf die Haut

entleeren (Haare dabei auseinanderlegen). Zwischen die Schulterblätter applizieren, um

ein Ablecken zu vermeiden. Es wird empfohlen die 5 ml Spot-on Pipette an 2 -

3 verschiedenen Orten über die Rückenlinie verteilt zu entleeren, um ein Hinunterlaufen

des Inhalts zu verhindern.

Therapie und Prophylaxe des Flohbefalls

Pyriprol tötet Flöhe innerhalb von 24 Stunden nach Behandlung ab. Eine Behandlung

schützt einen Monat lang vor neuem Flohbefall.

Therapie und Prophylaxe der allergischen Floh-Dermatitis

Pyriprol sollte in monatlichen Abständen verabreicht werden, wenn es als Teil einer

Behandlungsstrategie bei der durch Flohstiche verursachten allergischen Dermatitis (FAD)

eingesetzt wird. Sämtliche im selben Haushalt lebenden Hunde sollten ebenfalls behandelt

werden.

Therapie und Prophylaxe des Zeckenbefalls

Eine Behandlung schützt einen Monat lang vor neuem Zeckenbefall.

Zecken fallen normalerweise innerhalb 24 - 48 Stunden nach Infestation ab. Selten

konnten einzelne Zecken nach 48 Stunden auf dem Tier beobachtet werden. Deswegen

kann die Krankheitsübertragung durch Zecken auf den Hund nicht vollkommen

ausgeschlossen werden.

Der Hund sollte 48 Stunden vor bis 8 - 24 Stunden nach der Behandlung nicht gebadet

oder shampooniert werden.

Anwendungseinschränkungen

Kontraindikationen

Nicht bei Hunden anwenden, die jünger als 8 Wochen sind oder weniger als 2 kg wiegen.

Nicht bei Kaninchen anwenden.

Vorsichtsmassnahmen

Prac-tic darf bei trächtigen und laktierenden Hündinnen nur nach Nutzen/Risiko-Analyse

durch den Tierarzt angewendet werden. Im Falle einer versehentlichen Überdosierung,

siehe entsprechender Abschnitt unter "Unerwünschte Wirkungen".

Dieses Arzneimittel ist nur zur Applikation auf die Hautoberfläche von Hunden bestimmt.

Es darf nicht oral verabreicht werden.

Die Lösung darf nicht in die Augen des Tieres gelangen.

Bei sehr starkem Flohbefall sollte die Umgebung des Hundes gesaugt und evtl. mit einem

entsprechenden Insektizid behandelt werden.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

Falls das Präparat kurz nach der Behandlung abgeleckt wird, kann auf Grund der

Hilfsstoffe während kurzer Dauer vermehrter Speichelfluss auftreten.

An der Applikationsstelle konnten in sehr seltenen Fällen Alopezie, Fellverfärbung und

Juckreiz beobachtet werden.

Sehr selten kam es nach versehentlicher oraler Verabreichung des Pipetteninhalts zu

Todesfällen.

Falls Sie eine Nebenwirkung bei Ihrem Tier feststellen, teilen Sie diese Ihrem Tierarzt oder

Apotheker mit.

Überdosierung

Die einmalige dermale Verabreichung an Hunde in der 2 - 3 fachen Dosis wird

symptomlos vertragen. Hunde, denen das Dreifache der empfohlenen Maximaldosis

einmal monatlich 6 Monate lang verabreicht wurde, zeigten vereinzelt bis zu 3 Stunden

nach Applikation milde neurologische Symptome wie Koordinationsschwäche und Unruhe.

Die wiederholte dermale Applikation des 5-fachen der empfohlenen Dosis führte bei einem

von acht Hunden zu Tremor, Ataxie, Hecheln und Konvulsionen. Diese Symptome

verschwanden innerhalb von 18 Stunden nach Applikation.

Die einmalige Applikation des 10-fachen der empfohlenen Dosis führte zu

vorübergehenden klinischen Symptomen wie Tremor, Krämpfe und Konvulsionen,

Erbrechen und Appetitverlust, welche ca. 48 Stunden anhielten.

Wechselwirkungen

Keine bekannt.

Sonstige Hinweise

Bei Raumtemperatur unter 25°C aufbewahren.

Vor Feuchtigkeit schützen.

Nicht einfrieren.

Arzneimittel für Kinder unzugänglich aufbewahren.

Hunde nicht streicheln und von Kindern fernhalten bis die Applikationsstelle trocken ist.

Nach Gebrauch Hände mit Seife waschen. Kontakt mit Augen vermeiden.

Pyriprol kann im Wasser lebende Organismen schädigen. Hunde nicht kurz nach einer

Behandlung in einem Gewässer schwimmen lassen. Behälter und Arzneimittelreste sollen

unschädlich beseitigt werden.

Während der Anwendung nicht rauchen, essen oder trinken.

Das in Prac-tic enthaltene Lösungsmittel kann auf bestimmten Materialien, z.B. Leder,

Textilien, Kunststoffe und polierten Flächen, Flecken verursachen. Vermeiden Sie, dass

das Tier nach der Behandlung mit deraratigen Materialien in Kontakt kommt, bevor die

Applikationsstelle trocken ist.

Packungen

Spot-on Lösung M für Hunde von > 11 - 22 kg KGW, Packung zu 3 Pipetten

Abgabekategorie: C

Swissmedic Nr. 58'037

Informationsstand: 03/2015

Dieser Text ist behördlich genehmigt.

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17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ferric pyrophosphate citrate, decision type: , therapeutic area: , PIP number: P/0263/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ferric pyrophosphate citrate, decision type: , therapeutic area: , PIP number: P/0263/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ferric pyrophosphate citrate, decision type: , therapeutic area: , PIP number: P/0263/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib, decision type: , therapeutic area: , PIP number: P/0280/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib, decision type: , therapeutic area: , PIP number: P/0280/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib, decision type: , therapeutic area: , PIP number: P/0280/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): diphtheria toxin interleukin-3 Fusion Protein, decision type: , therapeutic area: , PIP number: P/0326/2018

Opinion/decision on a Paediatric investigation plan (PIP): diphtheria toxin interleukin-3 Fusion Protein, decision type: , therapeutic area: , PIP number: P/0326/2018

Opinion/decision on a Paediatric investigation plan (PIP): diphtheria toxin interleukin-3 Fusion Protein, decision type: , therapeutic area: , PIP number: P/0326/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Europe - EMA - European Medicines Agency

14-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Europe - EMA - European Medicines Agency

14-1-2019

Video: About the Therapeutic Goods Administration

Video: About the Therapeutic Goods Administration

A short video to take you through who we are and what we do

Therapeutic Goods Administration - Australia

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

Europe - EMA - European Medicines Agency

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

4-1-2019


New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

Europe - EMA - European Medicines Agency

1-1-2019

Advertising: Questions and answers on the Advertising Code

Advertising: Questions and answers on the Advertising Code

Answers to common questions about the Therapeutic Goods Advertising Code

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

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

19-12-2018


Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Europe - EMA - European Medicines Agency

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


Q&A: Good clinical practice (GCP)

Q&A: Good clinical practice (GCP)

Q&A: Good clinical practice (GCP)

Europe - EMA - European Medicines Agency

18-12-2018

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

TGA is seeking comments on the expansion and amendment of TGO 54. Closing date: 12 February 2019

Therapeutic Goods Administration - Australia