Drontal

Main information

  • Trade name:
  • Drontal Puppy Suspension
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Drontal Puppy Suspension
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • pyrantel
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0286/001
  • Authorization date:
  • 19-11-2010
  • EU code:
  • UK/V/0286/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2013

AN.00859/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Member

State Proposedname

AT DrontalJunior

DE WelpanfürWelpenundjungeHunde

EE DrontalPuppy

FI Welpanvet

FR DronstopChiot

ES Drontalsuspensiónoralparacachorrosyperros

jóvenes

IE DrontalOralSuspensionforPuppies

IS Welpanvet

LT DrontalPuppy

LV DrontalPuppy

NO Welpanvet

UK DrontalOralSuspensionforPuppies

Febantel15mg/ml/Pyrantel5mg/ml

OralSuspension

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains

Activesubstances:

Febantel 15.00mg

Pyrantel 5.00mg(aspyrantelembonate14.40mg)

Excipients:

Sodiumbenzoate(E211)2.05mg

Sodiumpropionate(E281)2.05mg

Ponceau4R(E124) 0.25mg

Forafulllistofexcipients,seesection6.1.

Revised:July2013

AN.00859/2012

Page2of6

3. PHARMACEUTICALFORM

Oralsuspension

Paleredsuspension

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs(puppiesandyoungdogsuptooneyearofage)

4.2 Indicationsforuse,specifyingthetargetspecies

Forthetreatmentofroundworminfectionsinpuppiesandyoungdogsuptooneyearof

agecausedby:

Ascarids: Toxocaracanis

Toxascarisleonina

Hookworms: Ancylostomacaninum

Uncinariastenocephala

Whipworm: Trichurisvulpis

4.3 Contraindications

Donotusesimultaneouslywithcompoundscontainingpiperazine.Seesections4.7and

4.8.

4.4 Specialwarnings

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent

repeateduseofananthelminticofthatclass.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thesafetyoftheproducthasnotbeenassessedinpuppiesyoungerthan2weeksand

weighinglessthan0.600kg.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse,

Avoiddirectcontactwiththeskinandeyes.Incaseofaccidentalspillagewashthe

affectedareaimmediatelywithcleanrunningwater.

Otherprecautions

None

Revised:July2013

AN.00859/2012

Page3of6

4.6Adversereactions(frequencyandseriousness)

Inveryrarecasesmildtransientdigestivetractsigns(e.g.,vomitingdiarrhoea)may

occur.

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantandlactatingbitches.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Theanthelminticeffectsofbothpyrantel(spasticparalysis)andpiperazine

(neuromuscularparalysis)maybeantagonisedwhenthetwodrugsareusedtogether.

4.9 Amountstobeadministeredandadministrationroute

DosageandTreatmentSchedule

Forasingleoraladminstration15mg/kgbodyweightfebanteland5mg/kgbodyweight

pyrantel(asembonate)correspondingto14.4mg/kgpyrantelembonate,equivalentto1

ml/kgbodyweight.

Throughintrauterineandtrans-mammaryinfection,ascaridinfestationmayoccurindogs

ataveryearlyage.Forsomeanimals,especiallyincaseofsevereinfections,elimination

ofascaridsmaybeincomplete,andapotentialriskofinfectionstohumanscannotbe

excluded.Whereepidemiologicallyappropriate,itisrecommendedthattreatmentshould

bestartedat2weeksofageandshouldbeperformedrepeatedlyatsuitableintervals

(forexampleevery2weeks),untilweaning.Otherwisetreatmentshouldbebasedupon

confirmedinfection,forexampletheresultsoffaecalexaminations.

MethodofAdministration

Oraladministration.Theproductmaybegivendirectlytotheanimalormixedwith

feed.Nospecialdietarymeasuresarenecessary.

Mixtheproductbyinversionofthecontainerbeforedrawingtherequireddose.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Dosesofupto5timesthetherapeuticleveloftheproducthavebeenadministeredto

puppiesandyoungdogswithoutclinicalsignsofintolerancearising.

At10timestherecommendeddosethefirstsignofintolerance –vomiting–wasevident.

4.11Withdrawalperiod(s)

Notapplicable.

Revised:July2013

AN.00859/2012

Page4of6

5. PHARMACOLOGICALPROPERTIES

Fixedcombinationoftwoanthelmintics:atetrahydro-pyrimidinederivative,pyrantel(as

theembonate)andapro-benzimidazole,febantel.

ATCvetcodeQP52AF02.

5.1 Pharmacodynamicproperties

Inthisfixedcombinationproduct,thepyrantelandfebantelactsynergisticallyagainst

nematodes(ascarids,hookwormsandwhipworms)ofdogs.Inparticular,thespectrumof

activitycoversToxocaracanis,AncyclostomacaninumandTrichurisvulpis.Published

dataarealsoavailabletoconfirmthatToxascarisleoninaandUncinariastenocephala

arealsosusceptibletothisparticularcombinationofactives.

Febantel,N-{2-[2,3-bis,(methoxycarbonyl)-guanidino]-5-(phenylthio)phenyl}-2-

methoxyacetamide,isapro-benzimidazole.Withinthemammaliansystemfebantel

undergoesringclosureformingfenbendazoleandoxfendazole.Itisthesechemical

entitieswhichexerttheanthelminticeffectbyinhibitionoftubulinpolymerization.

Formationofmicrotubulesistherebyprevented,resultingindisruptiontostructuresvital

tothenormalfunctioningofthehelminth.Glucoseuptake,inparticular,isaffected,

leadingtodepletionincellATP.Theparasitediesuponexhaustionofitsenergy

reserves,whichoccurs2-3dayslater.

Pyrantel,(E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl)vinyl]pyrimidinepamoate

belongstothetetrahydropyrimidinetype.Itsmodeofactionistostimulatenicotinic

cholinergicreceptorsinducingspasticparalysisandtherebyallowingremovalfromthe

gastro-intestinal(GI)systembyparalysis.

5.2 Pharmacokineticparticulars

Literaturereportsindicateafteroralapplicationoftherecommendeddoseof1ml/kg

bodyweight(correspondingto14.4mg/kgpyrantelembonateand15mg/kgfebantel)

maximumserumconcentrationsforfebantelwerefoundbetween1and6hourswithwith

aC

of0.019mg/ltwohoursafterdosing.Asfebantelasapro-drugismetabolisedto

fenbendazolwhichisfurtherconvertedtooxfendazole,alsothesemetaboliteswere

measured.C

offebendazolewas0.130mg/lafter3hoursandC

ofoxfendazole

was0.157mg/latabout5hoursafterapplication.

TheC

ofpyrantel(measuredaspyrantelbase)was0.084mg/l2.5hoursafter

application.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumbenzoate(E211)

Sodiumpropionate(E281)

Ponceau4R(E124)

Sodiumdihydrogenphosphatedihydrate

Sorbitanoleate(E494)

PovidoneK25(E1202)

Polysorbate80(E433)

Revised:July2013

AN.00859/2012

Page5of6

Docusatesodium

Bentonite(E558)

Citricacidanhydrous(E330)

Xanthangum(E415)

Propyleneglycol(E1520)

Purifiedwater

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproduct

aspackagedforsale:

5years

Shelf-lifeafterfirstopeningtheimmediate

packaging:

12weeks

6.4.Specialprecautionsforstorage

Donotuseafterexpirydate.

Thisunopenedveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.Afteropening,storetheproductatatemperaturenotexceeding25ºC.

6.5Natureandcompositionofimmediatepackaging

Materialoftheprimarycontainer:

Whitehighdensitypolyethylene

bottle

Whitepolypropylenescrewclosure

Colourlesslowdensity

polyethyleneadapterinsert

Containervolumes: 50ml,100ml

(Notallpacksizesmaybe

marketed)

Devicessupplied(ifrelevant) 5mltransparentpolypropylene

syringewithrubberplunger

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Revised:July2013

AN.00859/2012

Page6of6

7. MARKETINGAUTHORISATIONHOLDER

UK IE

Bayerplc,

AnimalHealthDivision,

BayerHouse,

StrawberryHill,

Newbury,

BerkshireRG141JA BayerLtd,

AnimalHealthDivision,

TheAtrium,

BlackthornRoad,

Dublin18.

Ireland

8. MARKETINGAUTHORISATIONNUMBER

UK IE

Vm00010/4102 VPA10021/53/1

9. DATEOFFIRSTAUTHORISATION

17April1998

10. DATEOFREVISIONOFTHETEXT

July2013

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Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

Tegemoetkoming Q-koorts

Tegemoetkoming Q-koorts

Het kabinet stelt € 14,5 miljoen beschikbaar als tegemoetkoming voor mensen met de diagnose chronische Q-koorts, Q-koorts­vermoeidheids­syndroom (QVS) of met een QVS gelijkend ziektebeeld. Ook de nabestaanden van overleden chronische Q-koortspatiënten kunnen in aanmerking komen voor een tegemoetkoming.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

30-11-2018

Consultation: Proposal for the regulation of IVD companion diagnostics

Consultation: Proposal for the regulation of IVD companion diagnostics

Closing date extended to 14 December 2018

Therapeutic Goods Administration - Australia

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

15-11-2018

Benepali (Samsung Bioepis NL B.V.)

Benepali (Samsung Bioepis NL B.V.)

Benepali (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018) 7557 of Thu, 15 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

14-11-2018

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Active substance: clopidogrel) - Centralised - Yearly update - Commission Decision (2018)7602 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Desloratadine ratiopharm (ratiopharm GmbH)

Desloratadine ratiopharm (ratiopharm GmbH)

Desloratadine ratiopharm (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2018)7603 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Ebymect (AstraZeneca AB)

Ebymect (AstraZeneca AB)

Ebymect (Active substance: dapagliflozin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)7605 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4162/WS/1380

Europe -DG Health and Food Safety

14-11-2018

Laventair Ellipta (Glaxo Group Ltd)

Laventair Ellipta (Glaxo Group Ltd)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Yearly update - Commission Decision (2018)7611 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Forxiga (AstraZeneca AB)

Forxiga (AstraZeneca AB)

Forxiga (Active substance: dapagliflozin) - Centralised - 2-Monthly update - Commission Decision (2018)7623 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2322/WS/1380

Europe -DG Health and Food Safety

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration