EQUEST

Základní informace

  • Název přípravku:
  • EQUEST 18.92 mg/g
  • Léková forma:
  • Perorální gel
  • Použij pro:
  • Zvířata
  • Léčitelství typu:
  • alopatický drog

Dokumenty

Lokalizace

  • K dispozici v:
  • EQUEST 18.92 mg/g
    Česká republika
  • Jazyk:
  • čeština

Terapeutická informace

  • Terapeutické skupiny:
  • koně, poníci
  • Terapeutické oblasti:
  • Milbemycins
  • Přehled produktů:
  • 9902328 - 1 x 14.8 g - aplikátor - -

Další informace

Stav

  • Zdroj:
  • USKVBL - ÚSTAV PRO STÁTNÍ KONTROLU VETERINÁRNÍCH BIOPREPARÁTŮ A LÉČIV
  • Registrační číslo:
  • 96/1340/97-C
  • Datum autorizace:
  • 29-12-1997
  • Poslední aktualizace:
  • 20-03-2018

Příbalovou informaci pro pacienta

PŘÍBALOVÁ INFORMACE

Equest 18,92 mg/g perorální gel

1.

JMÉNO A ADRESA DRŽITELE ROZHODNUTÍ O REGISTRACI A DRŽITELE

POVOLENÍ K VÝROBĚ ODPOVĚDNÉHO ZA UVOLNĚNÍ ŠARŽE, POKUD SE

NESHODUJE

Držitel rozhodnutí o registraci:

Zoetis Česká republika, s.r.o., Náměstí 14. října 642/17, 150 00 Praha 5, Česká republika

Výrobce odpovědný za uvolnění šarže:

Zoetis Manufacturing & Research Spain,S.L., Ctra. Camprodón s/n „la Riba“, 17813 Vall de Bianya

(Gerona), Španělsko

2.

NÁZEV VETERINÁRNÍHO LÉČIVÉHO PŘÍPRAVKU

Equest 18,92 mg/g perorální gel

Moxidectinum

3.

OBSAH LÉČIVÝCH A OSTATNÍCH LÁTEK

Žlutý perorální gel.

1 gram přípravku obsahuje:

Léčivá látka:

Moxidectinum

18,92 mg

Pomocné látky:

Benzylalkohol (E 1519)

37,84 mg

4.

INDIKACE

Přípravek je určen k léčbě invazí parazitů citlivých na moxidektin:

Velcí strongyli:

Strongylus vulgaris (dospělci a arteriální stadia)

Strongylus edenatus (dospělci a viscerální stadia)

Triodontophorus brevicauda (dospělci)

Triodontophorus serratus (dospělci)

Triodontophorus tenuicollis (dospělci)

Malí strongyli (dospělci a intraluminální larvální stadia):

Cyathostomum spp.

Cylicocyclus spp.

Cylicostephanus spp.

Cylicodontophorus spp.

Gyalocephalus spp.

Ascaridi:

Parascaris equorum (dospělci a larvální stadia)

Další druhy:

Oxyuris equi (dospělci a larvální stadia)

Habronema muscae (dospělci)

Gasterophilus intestinalis (L

Gasterophilus nasalis (L

Strongyloides westeri (dospělci)

Trichostrongylus axei

Proti malým strongylům navozuje přípravek persistentní účinnost po dobu dvou týdnů. Exkrece

vajíček malých strongylů je potlačena po dobu 90 dní.

Přípravek je účinný proti (vyvíjejícím se) nitroslizničním stádiím (L

4

) malých strongylů. Za 8 týdnů po

léčbě jsou eliminována časná (hypobiotická) L

3

stádia malých strongylů.

5.

KONTRAINDIKACE

Neaplikovat hříbatům do stáří 4 měsíců.

6.

NEŽÁDOUCÍ ÚČINKY

U mladých zvířat lze vzácně pozorovat ochablost spodního pysku a otok horního pysku.

Tyto nežádoucí reakce jsou přechodné a vymizí spontánně.

Četnost nežádoucích účinků je charakterizována podle následujících pravidel:

- velmi časté (nežádoucí účinek(nky) se projevil(y) u více než 1 z 10 ošetřených zvířat)

- časté (u více než 1, ale méně než 10 ze 100 ošetřených zvířat)

- neobvyklé (u více než 1, ale méně než 10 z 1000 ošetřených zvířat)

- vzácné (u více než 1, ale méně než 10 z 10000 ošetřených zvířat)

- velmi vzácné (u méně než 1 z 10000 ošetřených zvířat, včetně ojedinělých hlášení).

Jestliže zaznamenáte jakékoliv závažné nežádoucí účinky či jiné reakce, které nejsou uvedeny v této

příbalové informaci, oznamte to prosím vašemu veterinárnímu lékaři.

7.

CÍLOVÝ DRUH ZVÍŘAT

Koně, poníci.

8.

DÁVKOVÁNÍ PRO KAŽDÝ DRUH, CESTA(Y) A ZPŮSOB PODÁNÍ

Jednorázové perorální podání dávky 400 µg moxidektinu / kg ž.hm. za použití kalibrovaného

aplikátoru.

Aplikátor se drží zavíčkovaným koncem značkami doleva tak, aby bylo vidět na značkování podle

váhy (malé černé linky). Každá značka se vztahuje na 25 kg živé hmotnosti. Zelený číselný prstenec se

otáčí tak, aby se levá strana prstence kryla s váhou zvířete.

Pro zajištění přesného dávkování se doporučuje stanovení hmotnosti zvířat páskovou mírou.

Obsah aplikátoru je určen pro koně o živé hmotnosti 700 kg.

9.

POKYNY PRO SPRÁVNÉ PODÁNÍ

Nepoužívat stejný aplikátor na více než na jedno zvíře, pokud nejde o zvířata, která jsou na jedné

pastvě anebo přichází spolu přímo do styku. Přípravek Equest 18,92 mg/g perorální gel byl vyvinut

specificky jen pro použití u koní. Psi a kočky mohou vykazovat nežádoucí vedlejší reakce po požití

moxidektinu v koncentraci obsažené v přípravku, a to po požití rozlité pasty nebo při přístupu

k použitému aplikátoru.

Přechodné nežádoucí reakce se mohou dostavit po aplikaci dvojnásobku doporučované dávky u hříbat

a po trojnásobné dávce u dospělých zvířat.

Nežádoucí příznaky jsou deprese, inapetence, ataxie, dále ochabnutí spodního pysku 8 až 24 hodin po

aplikaci. Symptomatická léčba není obvykle zapotřebí a příznaky odeznívají zcela v průběhu 24 až 72

hodin. Specifické antidotum není známé.

Přípravek je neškodný pro březí a laktující klisny.

10.

OCHRANNÁ(É) LHŮTA(Y)

Maso 32 dní.

11.

ZVLÁŠTNÍ OPATŘENÍ PRO UCHOVÁVÁNÍ

Uchovávat mimo dohled a dosah dětí.

Uchovávejte při teplotě do 25

Doba použitelnosti po prvním otevření vnitřního obalu: 6 měsíců

Nepoužívejte po uplynutí doby použitelnost uvedené na etiketě.

12.

ZVLÁŠTNÍ UPOZORNĚNÍ

Zvláštní opatření určené osobám, které podávají veterinární léčivý přípravek zvířatům:

Je nutno vyvarovat se přímému kontaktu přípravku s pokožkou a s očima.

Doporučuje se použití ochranných rukavic.

Po aplikaci přípravku je nutno si umýt ruce a všechna místa, která přišla s ním do styku.

Během manipulace s přípravkem nekouřit, nepít a nejíst.

Při vniknutí přípravku do oka je třeba oko neprodleně propláchnout proudem vody. Při podráždění

vyhledejte lékařskou pomoc.

Jiná opatření týkající se vlivu na životní prostředí:

Moxidektin splňuje kritéria pro (velmi) perzistentní, bioakumulativní a toxickou (PBT) látku; z toho

důvodu je nutné expozici životního prostředí moxidektinu co možná nejvíce omezit. Léčba by měla

být podána pouze tehdy, jestliže je to nezbytné, a měla by být založena na počtu vajíček v trusu nebo

na zhodnocení rizika infestace na úrovni zvířete a/nebo stáda. Kvůli omezení průniku moxidektinu do

povrchových vod a na základě profilu vylučování moxidektinu při podání ve formě perorální lékové

formy koním by léčená zvířata neměla mít během prvního týdne po léčbě přístup k vodním tokům.

Podobně jako jiné makrocyklické laktony má moxidektin schopnost negativně ovlivňovat i jiné než

cílové organismy:

• Výkaly obsahující moxidektin vylučované na pastvě léčenými zvířaty mohou dočasně snižovat

množství organismů živících se trusem. U koní se po dobu více než 1 týdne po léčbě přípravkem

mohou vylučovat hladiny moxidektinu, které jsou potenciálně toxické pro brouky hnojníky a mouchy

žijící v trusu, a může docházet k poklesu množství fauny trusu.

• Moxidektin je svou podstatou toxický pro vodní organismy včetně ryb. Přípravek by se měl používat

pouze podle instrukcí na etiketě.

13.

ZVLÁŠTNÍ OPATŘENÍ PRO ZNEŠKODŇOVÁNÍ NEPOUŽITÝCH PŘÍPRAVKŮ

NEBO ODPADU, POKUD JE JICH TŘEBA

Všechen nepoužitý veterinární léčivý přípravek nebo odpad, který pochází z tohoto přípravku, musí být

likvidován podle místních právních předpisů. Přípravkem nekontaminujte vodní toky.

Přípravek je toxický pro ryby a další vodní organismy.

O možnostech likvidace nepotřebných léčivých přípravků se poraďte s vaším veterinárním lékařem.

Tato opatření napomáhají chránit životní prostředí.

14.

DATUM POSLEDNÍ REVIZE PŘÍBALOVÉ INFORMACE

Prosinec 2017

15.

DALŠÍ INFORMACE

Pouze pro zvířata.

Veterinární léčivý přípravek je vydáván pouze na předpis.

Balení: Aplikátor z vysokohustotního polyethylenu obsahující 14,8 g gelu, s graduovaným pístem

a uzávěrem z nízkohustotního polyethylenu. Baleno jednotlivě v krabičce.

Pokud chcete získat informace o tomto veterinárním léčivém přípravku, kontaktujte prosím

příslušného místního zástupce držitele rozhodnutí o registraci:

Zoetis Česká republika, s.r.o.

Náměstí 14. října 642/17, 150 00 Praha 5

Česká republika

Tel: +420 257 101 111

E-mail: infovet.cz@zoetis.com

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29-8-2018

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Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

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29-8-2018

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29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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28-6-2018

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The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

15-6-2018

Written Requests Issued

Written Requests Issued

Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies

FDA - U.S. Food and Drug Administration

30-5-2018

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Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

In 2016, as part of the implementation of the Act "for the restoration of biodiversity, nature and landscapes” and as requested by the Ministries of Agriculture, Health and Ecology, ANSES initiated an assessment weighing up the risks and benefits of plant protection products containing neonicotinoids, compared with their chemical and non-chemical alternatives. Today, ANSES is publishing its final opinion. For most uses of plant protection products containing neonicotinoids, sufficiently effective and ope...

France - Agence Nationale du Médicament Vétérinaire

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

17-5-2018

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

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

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

FDA - U.S. Food and Drug Administration

11-5-2018

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

FDA - U.S. Food and Drug Administration

3-5-2018

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA Approves Application for AquaBounty Salmon Facility in Indiana

FDA approved a supplemental New Animal Drug Application submitted by AquaBounty Technologies, Inc. The supplemental NADA requested FDA approval to raise AquAdvantage Salmon at a land-based contained facility near Albany, Indiana.

FDA - U.S. Food and Drug Administration

1-2-2018

Brexit, change of Reference Member State from UK to DK

Brexit, change of Reference Member State from UK to DK

The Danish Medicines Agency would like to inform marketing authorisation holders that we welcome being the Reference Member State (RMS) for MRP/DCP authorised medicines, should you request Denmark as the future RMS when the UK is leaving the EU.

Danish Medicines Agency

29-9-2017

New practice for follow-up information on adverse reaction reports

New practice for follow-up information on adverse reaction reports

The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies' requests for follow-up information on reports of suspected adverse reactions.

Danish Medicines Agency

3-7-2017

Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA

Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA

The Danish Medicines Agency no longer requests the direct transfer of serious and unexpected third-country adverse event reports for centrally authorised veterinary medicinal products.

Danish Medicines Agency

12-12-2016

Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products

Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products

Due to an increasing number of requests, we would like to point out the phasing-out plan for NeeS and the transition to eCTD/VNeeS as outlined in the eSubmission Roadmap. The format requirements apply to applications for marketing authorisations for medicinal products as well as maintenance of these (variations, renewals etc.). The changes do not apply to parallel import and parallel distribution.

Danish Medicines Agency

28-10-2016

Available time slots for DCP applications with Denmark as reference member state

Available time slots for DCP applications with Denmark as reference member state

Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available.

Danish Medicines Agency

14-11-2014

Available time slots in Q1 2015 for DCP applications with Denmark as reference member state

Available time slots in Q1 2015 for DCP applications with Denmark as reference member state

Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available in the first quarter of 2015.

Danish Medicines Agency

28-1-2014

Time slots for DCP procedures with Denmark as Reference Member State (RMS)

Time slots for DCP procedures with Denmark as Reference Member State (RMS)

The Danish Health and Medicines Authority wishes to inform future applicants of the possibility to request for a time slot to applications for marketing authorisations through the decentralised procedure (DCP) where Denmark is acting as reference member state (RMS).

Danish Medicines Agency

5-1-2012

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

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

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

Danish Medicines Agency

5-7-2011

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

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

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

Danish Medicines Agency

6-5-2011

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

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

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

Danish Medicines Agency

31-3-2010

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

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

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

Danish Medicines Agency

17-12-2009

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

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

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

Danish Medicines Agency

2-10-2009

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

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

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

Danish Medicines Agency

30-6-2009

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

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

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

Danish Medicines Agency

30-6-2009

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

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

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

Danish Medicines Agency

4-5-2009

Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

Danish Medicines Agency

30-4-2009

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

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

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

Danish Medicines Agency

14-2-2008

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

Following a request from the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status for medicinal products authorised for marketing in Denmark in ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

14-9-2018

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here:  https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgW5  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here:  https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgDd 

FDA - U.S. Food and Drug Administration

7-6-2018

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

FDA - U.S. Food and Drug Administration

16-5-2018

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Intervet International B.V.)

Bravecto Plus (Active substance: fluralaner / moxidectin) - Centralised - Authorisation - Commission Decision (2018)3019 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4440

Europe -DG Health and Food Safety