Oxyglobin

Primær information

  • Handelsnavn:
  • Oxyglobin
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Oxyglobin
    Den Europæiske Union
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Hunde
  • Terapeutisk område:
  • Blodsubstitutter og perfusionsløsninger
  • Terapeutiske indikationer:
  • Oxyglobin yder oxygenbærende støtte til hunde, der forbedrer de kliniske tegn på anæmi i mindst 24 timer uafhængigt af den underliggende tilstand.

Andre oplysninger

Status

  • Kilde:
  • EMA - European Medicines Agency
  • Autorisation status:
  • autoriseret
  • Autorisationsnummer:
  • EMEA/V/C/000045
  • Autorisation dato:
  • 29-11-1999
  • EMEA kode:
  • EMEA/V/C/000045
  • Sidste ændring:
  • 24-02-2018

Offentlige vurderingsrapport

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8447

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

EMA/499067/2007

EMEA/V/C/000045

EPAR-sammendrag for offentligheden

Oxyglobin

Hæmoglobin glutamer-200

Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport. Formålet er at

forklare, hvordan Udvalget for Veterinærlægemidler (CVMP) vurderede den fremlagte

dokumentation og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes. Dette

dokument kan ikke erstatte den personlige drøftelse med din dyrlæge. Hvis du ønsker yderligere

oplysninger om dit dyrs sygdomstilstand eller behandling, kan du kontakte din dyrlæge. Hvis du

ønsker yderligere oplysninger om grundlaget for CVMP's anbefalinger, kan du læse de faglige

drøftelser (også en del af denne EPAR).

Hvad er Oxyglobin?

Oxyglobin indeholder hæmoglobinglutamer-200 fra kvæg (med en styrke på 130 mg/ml), der hører

til klassen af lægemidler med en iltbærende aktion. Oxyglobin er en opløsning til infusion (drop i en

vene).

Hvad anvendes Oxyglobin til?

Oxyglobin anvendes til at øge iltindholdet i blodet hos hunde med anæmi (lavt antal røde

blodlegemer). Der skal gives Oxyglobin i mindst 24 timer.

Oxyglobin varmes først op til 37° C og gives herefter til hunden med en dosis på 30 ml pr. kilo

kropsvægt og en hastighed på op til 10 ml/kg pr. time. Den mest hensigtsmæssige dosis afhænger

af, hvor alvorlig anæmien er, og i hvor lang tid hunden har været anæmisk, samt af den ønskede

varighed af lægemidlets effekt. Oxyglobin er kun beregnet til engangsbrug. Det er ikke nødvendigt

at tilpasse Oxyglobin efter hundens blodtype. Yderligere oplysninger fremgår af indlægssedlen.

Oxyglobin

EMA/499067/2007

Page 2/3

Hvordan virker Oxyglobin?

Oxyglobin er en hæmoglobinbaseret iltbærende opløsning. Den indeholder hæmoglobinglutamer-

200, der er fremstillet ud fra hæmoglobin (proteinet i de røde blodlegemer, der transporterer ilt

rundt i kroppen), som er ekstraheret fra koblod og fortyndet i en standardopløsning (Ringers

laktat), der benyttes til at erstatte blodvolumen. Når Oxyglobin gives til hunde, øges mængden af

hæmoglobin i blodet samt blodvolumenet i kroppen. Herved øges mængden af ilt, der

transporteres i blodet i arterierne, hvilket er med til at reducere symptomerne på anæmi.

Hvordan blev Oxyglobin undersøgt?

Oxyglobin blev afprøvet i en undersøgelse med hunde med kort- eller langvarig anæmi som følge

af tilstande som blodtab, unormal nedbrydning af røde blodlegemer eller for lav produktion af røde

blodlegemer. I undersøgelsen blev Oxyglobins effekt sammenlignet med ingen behandling.

Hvilken fordel viser undersøgelserne, at der er ved Oxyglobin?

I hovedundersøgelsen med hunde havde 95 % af de dyr, som blev behandlet med Oxyglobin, ikke

behov for anden iltbærende behandling efter 24 timer sammenlignet med 32 % af de hunde, som

ikke fik behandling. Der gik længere tid, før det var nødvendigt med yderligere behandling af

hunde, som blev behandlet med Oxyglobin. Lægemidlet øgede også niveauet af hæmoglobin i

blodet og forbedrede hundens fysiske tilstand.

Yderligere forsøg understøttede disse resultater, idet det blev påvist, at Oxyglobin kan optage,

transportere og frigive ilt hos andre dyr end køer. Denne ilt kan så tilføres vævet, f.eks. muskler.

Hvilken risiko er der forbundet med Oxyglobin?

De bivirkninger, der ses i forbindelse med Oxyglobin, skyldes både lægemidlet og den

bagvedliggende årsag til anæmien. De omfatter misfarvning af huden, slimhinderne (foringen af

legemshuler) og sclerae (det hvide i øjnene), mørk afføring og misfarvet eller grumset

(uigennemsigtig) urin. En almindelig bivirkning er 'overbelastning af kredsløbet' (når blodet siver

ud gennem blodkarrene), hvilket giver takypnø (hurtig vejrtrækning), dyspnø (åndenød),

disharmoniske lungelyde og lungeødem (ophobning af væske i lungerne). Andre almindelige

bivirkninger er opkastning, appetitløshed og feber. Den fuldstændige liste over de indberettede

bivirkninger ved Oxyglobin fremgår af indlægssedlen.

Oxyglobin må ikke anvendes til dyr, der har fået Oxyglobin tidligere, eller til hunde, der har øget

risiko for overbelastning af kredsløbet med tilstande som oliguri eller anuri (sjælden eller ingen

vandladning) eller fremskreden hjertesygdom.

Hvilke forholdsregler skal der træffes af den, der giver lægemidlet eller

kommer i berøring med dyret?

Ikke relevant.

Hvorfor blev Oxyglobin godkendt?

Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Oxyglobin er større end

risiciene, når lægemidlet anvendes til at yde iltbærende støtte til hunde og afhjælpe de kliniske

Oxyglobin

EMA/499067/2007

Page 3/3

tegn på anæmi i mindst 24 timer, uafhængigt af den bagvedliggende tilstand, og anbefalede

udstedelse af markedsføringstilladelse for Oxyglobin. Benefit/risk-forholdet fremgår af afsnittet om

den videnskabelige drøftelse i denne EPAR.

Andre oplysninger om Oxyglobin

Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske

Union for Oxyglobin den 14. juli 1999. Oplysninger om udleveringsbestemmelserne for dette

lægemiddel findes på etiketten på emballagen.

Dette sammendrag blev sidst ajourført i marts 2012.

Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning

B. INDLÆGSSEDDEL

INDLÆGSSEDDEL

Oxyglobin 130 mg/ml infusionsvæske, opløsning til hunde.

1.

NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN

SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER

ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA

Indehaver af markedsføringstilladelsen

OPK Biotech Netherlands BV

Teleportboulevard 140

1043EJ

Amsterdam

The Netherlands

Fremstiller af batchfrigivelse:

Dales Pharmaceutical Ltd.

Snaygill Industrial Estate

Keighley Road

Skipton

North Yorkshire, BD23 2RW United Kingdom

2.

VETERINÆRLÆGEMIDLETS NAVN

Oxyglobin 130 mg/ml infusionsvæske, opløsning til hunde.

3.

ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER

Hæmoglobin glutamer-200 (bovine)- 130 mg/ml

4.

INDIKATIONER

Oxyglobin giver oxygenbærende støtte til hunde, hvorved der opnås forbedring af de kliniske tegn på

blodmangel i mindst 24 timer, uafhængig af de tilgrundliggende årsager.

5.

KONTRAINDIKATIONER

Bør ikke anvendes til dyr som tidligere er behandlet med Oxyglobin.

Plasma volumen udvidere, såsom Oxyglobin, er kontraindikeret til hunde, der er prædisponerede for

kredsløbsforstyrrelser pga. tilstande, såsom oliguria eller anuria eller fremskreden hjertelidelse (det vil

sige hjerteinsufficiens) eller på anden måde meget forringet hjertefunktion.

Oxyglobin er udelukkende beregnet til engangsadministration.

6.

BIVIRKNINGER

Under det kliniske sikkerhedsstudie af virkningen, er der set bivirkninger, der kan være relaterede til

Oxyglobin og/eller den tilgrundliggende sygdom, der forårsager blodmangelen. De bivirkninger, der er

observeret, inkluderer mild til moderat misfarvning af slimhinder, sclera, og urin skyldes metabolisme

og/eller udskillelse af hæmoglobin. Bivirkninger viste sig sædvanligvis ved opkastning, tab af appetit,

feber og overbelastning af kredsløbet med de dertil knyttede kliniske signaler, som fx tachypnø,

Dosering

(ml/kg)

Omgående post-

infusion plasma

koncentration* (g/dl)

Varighed (timer):

Oxyglobinniveauer

over 1 g/dl

Renset for plasma

(dage)***

2.0–2.5

23–39

4–6

3.4–4.3

66–70

5–7

3.6–4.8

74–82

5–9**

dyspnæ, anstrengte lungelyde og lungeødem, overbelastning af kredsløbet kontrolleres ved at nedsætte

administrationsraten. Lejlighedsvis noterede bivirkninger er diarré, affarvning af huden hjertearytmi og

i meget sjældne tilfælde nystagmus.

Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne

indlægsseddel, bedes De kontakte Deres dyrlæge.

7.

DYREARTER

Hunde

8.

DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)

Den anbefalede dosering af Oxyglobin er 30 ml/kg/st kropsvægt givet intravenøst i doser op til 10

ml/kg/st/time. I visse kliniske situationer vil en dosering på 15-30 ml/kg/st være passende. Den

optimale dosering baseres på baggrund af graden af kronisk anæmi og den ønskede varighed af effekten

(Se skema A Pharmakokinetiske parametre)

Skema A: Pharmakokinitiske parametre ved flere doseringsniveauer efter en enkelt infusion med

Oxyglobin

* område baseret på ringe ± SD

** område baseret på vurderet middel værdier inden for 95 % af forudsigelige intervaller

*** område baseret på 5 terminale halv-liv

9.

OPLYSNINGER OM KORREKT ANVENDELSE

Fjern overfolien lige før brugen. Anvend præparatet indenfor 24 timer. Oxyglobin skal indgives ved

anvendelse af aseptisk teknik via standard intravenøst infusionssæt og kateter.

Som med alle former for administration af intravenøse væsker, bør Oxyglobin opvarmes til 37 ° C

inden administrationen. Mikrobølger må ikke anvendes. Må ikke overopvarmes.

Anvend ikke præparatet sammen med andre væsker eller medicinske produkter via det samme

infusionssæt. Bland ikke andre medikamenter eller andre opløsninger i posen. Bland ikke indholdet af

mere end en pose sammen.

10.

TILBAGEHOLDELSESTID

Ikke relevant.

11.

EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING

Opbevares utilgængeligt for børn

Må ikke opbevares over 30 °C. Må ikke nedfryses. Skal anvendes inden for 24 timer, efter at overfolien

er fjernet.

Må ikke anvendes efter den udløbsdato, som er angivet på etiketten

12.

SÆRLIG(E) ADVARSEL/ADVARSLER

Må ikke anvendes til dyr som tidligere er behandlet med Oxyglobin'.

Ledsagende behandling af årsagen til blodmangelen skal påbegyndes.

Dyret må ikke overhydreres før behandlingen. På grund af de plasmaudvidende egenskaber hos

Oxyglobin, skal muligheden for overbelastning af kredsløbet overvejes grundigt, specielt når der

behandles med supplerende intravenøse opløsninger, især colloidale opløsninger. Tegn på

overbelastning af kredsløbet skal overvåges nøje, enten på monitor eller ved måling af det centrale

venetryk. Hvis der er tegn på overbelastning af kredsløbet, og/eller hvis blodtrykket stiger til et klinisk

uacceptabelt niveau, skal injektionen af Oxyglobin midlertidigt stoppes og påbegyndes igen med en

langsommere hastighed når symptomerne fortager sig og/eller når blodtrykket falder.

Behandling med Oxyglobin resulterer i en svag stigning i PCV (pakket cellestørrelse) umiddelbart efter

infusionen.

Sikkerheden og effekten af Oxyglobin er ikke blevet undersøgt hos hunde med thrombocytopenia med

aktiv blødning, oliguria eller anuria, eller fremskredet hjertelidelse.

Sikkerheden af Oxyglobin til anvendelse hos tæver, der er drægtige eller diegivende er ikke bestemt.

Anvendelse af produktet på disse dyr kan ikke anbefales.

13.

EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF

UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT

Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse

med de lokale krav.

14.

DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN

Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske

Lægemiddelagentur (EMA)

http://www.ema.europa.eu/.

15.

ANDRE OPLYSNINGER

Klinisk patologi

Kemi: Tilstedeværelsen af Oxyglobin i serum kan interferere med kolorometrisk aflæsning og resultere

i kunstig forøgelse eller formindskelse i resultaterne af serumprøverne, afhængig af den anviste dosis,

tidspunktet siden infusionen, typen af analysator og de anvendte reagenter. (Kontakt forhandleren for

specifikke data).

Hæmatologi: Ingen forstyrrelse. Kontroller at hæmoglobinen er målt og ikke udregnet på baggrund af

antallet af røde blodceller.

Koagulering: Prothrombintiden (PT) og den aktiverede partielle thromboplastintid (aPTT) kan nøje

bestemmes med metoder, som kan være mekaniske, magnetiske og lysspredning.

De optiske metoder er ikke pålidelige til koagulationsprøver ved tilstedeværelse af Oxyglobin.

Urinanalyse: Sedimentundersøgelsen er nøjagtig. Målepindsmåling (dvs. pH, glukose, ketoner, protein)

er ikke nøjagtige ved tilstedeværelse af stor misfarvning af urinen.

60 ml infusionspose.

125 ml infusionspose.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

De bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis De

ønsker yderligere oplysninger om dette lægemiddel.

Deutschland

Albrecht GmbH

Hauptstr. 6-8

88326 Aulendorf

Tel.: +49 (0) 752 52 05 10

Fax: +49 (0) 752 57 00 5

United Kingdom

Dechra Veterinary Products Limited

Sansaw Business Park, Hadnall,

Shrewsbury, Shropshire, SY4 4AS

Tel.: +44 (0) 19 39 21 12 00

Fax: +44 (0) 19 39 21 12 01

France

Dechra Veterinary Products SAS

60, Avenue du Centre,

78180 Montigny-le-Bretonneux

Tel: +33 1 3048 7140

Fax: +33 1 3081 9963

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FDA - U.S. Food and Drug Administration

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety