Furexel Combi

Hauptinformation

  • Handelsname:
  • Furexel Combi Paste zum Einnehmen 15,5 mg/g; 77,5 mg/g
  • Dosierung:
  • 15,5 mg/g; 77,5 mg/g
  • Darreichungsform:
  • Paste zum Einnehmen
  • 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:
  • Furexel Combi Paste zum Einnehmen 15,5 mg/g; 77,5 mg/g
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Anthelmintica

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE-V279221
  • Letzte Änderung:
  • 17-04-2018

Packungsbeilage

Bijsluiter – DE Versie

FUREXEL COMBI

PACKUNGSBEILAGE

1.

NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND, WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE

CHARGENFREIGABE VERANTWORTLICH IST

Zulassungsinhaber:

Merial Belgium SA/NV

Avenue Arianelaan 16

1200 Brüssel

Belgien

Hersteller:

Merial, Laboratoire de Toulouse

4 Chemin du Calquet

F-31057 Toulouse

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

Furexel Combi, Paste zum Einnehmen.

3.

WIRKSTOFFE UND SONSTIGE BESTANDTEILE

Jeder Applikator mit 7,74 g Paste enthält:

Ivermectin 15,5 mg/g

Praziquantel 77,5 mg/g

Sonstige Bestandteile:

Gelborange S (E110)

0,003 g

Titandioxid (E171)

0,155 g

Butylhydroxyanisol (E320)

0,002 g

4.

ANWENDUNGSGEBIETE

Zur Behandlung von Mischinfestationen mit Zestoden und Nematoden oder Arthropoden bei

Pferden.

Furexel Combi wirkt gegen folgende Parasiten:

Bandwürmer, adulte:

Anoplocephala perfoliata

Anoplocephala magna

Große Strongyliden:

Strongylus vulgaris (adulte und arterielle Larvenstadien)

Strongylus edentatus (adulte und 4. Larvenstadien)

Strongylus equinus (adulte)

Triodontophorus spp. (adulte)

Triodontophorus brevicauda

Triodontophorus serratus

Craterostomum acuticaudatum (adulte)

Bijsluiter – DE Versie

FUREXEL COMBI

Kleine Strongyliden, adulte und immature (intraluminale 4. Larvenstadien) oder

Cyathostoma, einschließlich Benzimidazol-resistente Stämme :

Coronocyclus spp.

Coronocyclus coronatus

Coronocyclus labiatus

Coronocyclus labratus

Cyathostomum spp.

Cyathostomum catinatum

Cyathostomum pateratum

Cylicocyclus spp.

Cylicocyclus ashworthi

Cylicocyclus elongatus

Cylicocyclus insigne

Cylicocyclus leptostomum

Cylicocyclus nassatus

Cylicodontophorus spp.

Cylicodontophorus bicornatus

Cylicostephanus spp.

Cylicostephanus calicatus

Cylicostephanus goldi

Cylicostephanus longibursatus

Cylicostephanus minutus

Parapoteriostomum spp.

Parapoteriostomum mettami

Petrovinema spp.

Petrovinema poculatum

Poteriostomum spp.

Poteriostomum

Magenfadenwurm, adulte: Trichostrongylus axei

Pfriemenschwanz, adulte und immature (4.Larvenstadien): Oxyuris equi

Spulwurm, adulte, 3. und 4. Larvenstadien: Parascaris equorum

Mikrofilarien: Onchocerca spp..

Zwergfadenwurm, adulte: Strongyloides westeri

Rollschwanz, adulte: Habronema muscae

Magendasseln, alle Larvenstadien: Gasterophilus spp..

Lungenwurm, adulte und immature (inhibierte 4. Larvenstadien): Dictyocaulus arnfieldi

5.

GEGENANZEIGEN

Nicht bei Stuten anwenden, deren Milch für den menschlichen Verzehr vorgesehen ist.

Dieses Tierarzneimittel ist nur für Pferde zugelassen. Bei Katzen, Hunden, besonders Collies,

Bobtails und ihnen verwandten Rassen oder deren Mischlingen können Nebenwirkungen durch

Bijsluiter – DE Versie

FUREXEL COMBI

das in diesem Tierarzneimittel enthaltene Ivermectin auftreten, falls diese Pastenreste aufnehmen

oder zu gebrauchten Applikatoren Zugang haben. Dies gilt auch für Schildkröten.

6.

NEBENWIRKUNGEN

Vereinzelt zeigen Pferde mit starkem Befall von Onchocerca

spp.

microfilariae

nach der

Behandlung Ödeme und Juckreiz, was vermutlich auf die massive Abtötung von Mikrofilarien

zurückzuführen ist. In der Regel klingen diese Symptome innerhalb weniger Tage wieder ab. Eine

symptomatische Behandlung kann jedoch mitunter ratsam sein.

Bei schwerem Bandwurmbefall können Anzeichen einer leichten, vorübergehenden Kolik und

weiche Fäzes auftreten.

Gelegentlich wurde nach Verabreichung von Furexel Combi über Entzündungen in der

Maulhöhle, Lippen und Zunge berichtet, welches sich in verschiedenen klinischen Symptomen

wie Ödemen,

vermehrtem Speicheln, Hautrötungen, Störungen der Zungenmotorik und

Stomatitis äußern kann. Diese Erscheinungen waren vorübergehender Natur, traten innerhalb

einer Stunde nach der Behandlung auf und waren innerhalb von 24 bis 48 Stunden wieder

verschwunden. Im Falle schwerwiegender oraler Reaktionen ist eine symptomatische Behandlung

empfehlenswert.

Falls Sie Nebenwirkungen, insbesondere solche, die nicht in der Packungsbeilage aufgeführt sind,

bei Ihrem Tier feststellen, teilen Sie diese Ihrem Tierarzt oder Apotheker mit.

7.

ZIELTIERARTEN

Pferde.

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Zur oralen Anwendung.

Die empfohlene Dosierung beträgt 0,2 mg Ivermectin pro kg Körpergewicht und 1 mg

Praziquantel pro kg Körpergewicht, entsprechend 1,29 g Paste pro 100 kg Körpergewicht bei

einmaliger Verabreichung.

Körpergewicht und Dosierung sollen vor der Behandlung möglichst genau bestimmt werden. Der

Inhalt einer Applikationsspritze reicht für ein Pferd mit 600 kg Körpergewicht. Über die

Markierungen können Körpergewichte in jeweils 100-kg-Schritten eingestellt werden. Die

Einstellung der berechneten Dosis erfolgt an der Applikationsspritze mit dem Rändelring auf der

entsprechenden Gewichtsmarke am Stempelschaft.

Parasitenbekämpfungsprogramm:

Zur erfolgreichen Kontrolle von Band- und Rundwurminfestationen sollten geeignete

Behandlungsprogramme sowie das Betriebsmanagement mit dem behandelnden Tierarzt

besprochen werden.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Furexel Combi ist nur zum Eingeben bestimmt. Zum Gebrauch den Stempelschaft halten, den

Rändelring ein Viertel nach links drehen und so weit bewegen, bis die vorgeschriebene

entsprechende Gewichtsmarkierung eingestellt ist. Dann durch eine Vierteldrehung nach rechts

den Ring fixieren, so dass die beiden Pfeile - der auf dem Ring sichtbare und der am

Bijsluiter – DE Versie

FUREXEL COMBI

Stempelschaft - übereinstimmen. Es ist darauf zu achten, dass sich in der Maulhöhle keine

Futterreste

befinden.

Verschlusskappe

der Applikationsspritze

nehmen.

Applikationsspritze in den Zwischenzahnbereich einschieben und die Paste auf den Zungengrund

applizieren. Dann den Kopf des Pferdes für ein paar Sekunden nach oben halten, um das

Abschlucken der Paste zu gewährleisten.

10.

WARTEZEIT

Essbare Gewebe: 30 Tage.

Nicht bei Stuten anwenden, deren Milch für den menschlichen Verzehr vorgesehen ist.

11.

BESONDERE LAGERUNGSHINWEISE

In der Originalverpackung aufbewahren.

Nach Gebrauch die Applikationsspritze wieder verschließen

Sie dürfen das Arzneimittel nach dem auf nicht mehr anwenden.

Dauer der Haltbarkeit nach Anbruch des Behältnisses: 2 Jahre.

Arzneimittel außer Reich- und Sichtweite von Kindern aufbewahren.

12.

BESONDERE WARNHINWEISE

Besondere Warnhinweise

Folgende Situationen sollten vermieden werden, da diese zur Erhöhung der Resistenz und

letztendlich zur Unwirksamkeit der Behandlung führen können:

Zu häufige und wiederholte Anwendung von Anthelminthika einer Substanzklasse über

einen längeren Zeitraum,

Unterdosierung,

verursacht

durch

Unterschätzung

Körpergewichts,

falsche

Verabreichung

Tierarzneimittels

oder

durch

mangelhafte

Einstellung

Dosiervorrichtung (sofern vorhanden).

Bei Verdacht auf Anthelminthika-Resistenz sollten weiterführende Untersuchungen mit

geeigneten Tests (z. B. Eizahlreduktionstest) durchgeführt werden. Falls die Testergebnisse

deutlich auf die Resistenz gegenüber einem bestimmten Anthelminthikum hinweisen, sollte

ein Anthelminthikum aus einer anderen Substanzklasse und mit unterschiedlichem

Wirkungsmechanismus Verwendung finden.

Über Resistenz gegen makrocyclische Lactone (einschließlich Ivermectin) wird bei

Parascaris equorum, bei Pferden innerhalb der EU berichtet. Daher sollte sich auf nationaler

Ebene (regional, betrieblich) die Anwendung dieses Tierarzneimittels auf epidemiologische

Erhebungen

Empfindlichkeit

gastro-

intestinalen

Nematoden,

sowie

Expertenempfehlungen zur Eindämmung weiterer Anthelminthika-Resistenzen stützen.

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren

Da für Furexel Combi keine Untersuchungen zur Verträglichkeit bei Fohlen im Alter unter 2

Monaten oder bei Zuchthengsten durchgeführt wurden, wird die Behandlung dieser Zielgruppen

nicht empfohlen.

Besondere Vorsichtsmaßnahmen für den Anwender

Nach Gebrauch Hände waschen.

Bijsluiter – DE Versie

FUREXEL COMBI

Während der Anwendung nicht rauchen, trinken oder essen.

Da das Tierarzneimittel Haut und Augen reizen kann, sollte bei der Anwendung jeder Kontakt

damit vermieden werden. Bei versehentlichem Kontakt reichlich mit Wasser abspülen.

Bei versehentlicher Einnahme oder Reizung am Auge ist unverzüglich ein Arzt zu Rate zu ziehen

und die Packungsbeilage oder das Etikett vorzuzeigen.

Anwendung während der Trächtigkeit und Laktation

Untersuchungen an Labortieren haben weder für Ivermectin noch für Praziquantel in der

empfohlenen therapeutischen Dosierung Anhaltspunkte für teratogene oder embryotoxische

Wirkungen erbracht.

Die Kombination Ivermectin-Praziquantel kann nach den ersten drei Monaten der Trächtigkeit

und während der Laktation verabreicht werden.

Die Anwendung von Furexel Combi in den ersten drei Monaten der Trächtigkeit wurde nicht

untersucht. Eine Anwendung sollte deshalb erst nach einer sorgfältigen Nutzen/Risiko-Analyse

des verantwortlichen Tierarztes erfolgen.

Überdosierung (Symptome, Notfallmaßnahmen und Gegenmittel)

Es wurden keine unerwünschten Tierarzneimittelwirkungen bei Fohlen im Alter von 2 Monaten

nach Verabreichung von Furexel Combi bis zum 3-fachen der therapeutischen Dosis, sowie bei

erwachsenen Pferden nach Gabe der 10-fachen therapeutischen Dosis beobachtet.

Vorübergehend verminderte Futteraufnahme, erhöhte Körpertemperatur, vermehrtes Speicheln

und eingeschränktes Sehvermögen wurden bei Pferden beobachtet, die 2-mal die 10-fache

Dosierung einer Ivermectinpaste oder 1-mal die 10-fache Dosierung von Furexel Combi (d.h. 2

mg/kg Körpergewicht) erhalten hatten. Alle Veränderungen waren innerhalb von 5 Tagen wieder

verschwunden.

Ein Antidot ist nicht bekannt. Eine symptomatische Therapie kann jedoch von Vorteil sein.

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON

NICHT VERWENDETEM ARZNEIMITTEL ODER VON

ABFALLMATERIALIEN, SOFERN ERFORDERLICH

Nicht verwendete Tierarzneimittel oder davon stammende Abfallmaterialien sind entsprechend den

nationalen Vorschriften zu entsorgen.

Das Tierarzneimittel darf nicht in Gewässer gelangen, da es eine Gefahr für Fische und andere

Wasserorganismen darstellen kann.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

September 2017

15.

WEITERE ANGABEN

BE-V279221

Verschreibungspflichtig

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11-10-2018

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19-9-2018

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12-9-2018

Kabinet investeert in eerste 1000 dagen kind

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11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

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Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

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

17-8-2018

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Minister Bruno Bruins (Medische Zorg) heeft met succes onderhandeld over de prijs van het middel daratumumab in twee verschillende combinatietherapieën voor de vervolgbehandeling van de ziekte van Kahler (multipel myeloom). Bij deze ziekte is er sprake van kwaadaardige woekering van plasmacellen in het beenmerg. Daratumumab was al beschikbaar als zogenaamde monotherapie voor patiënten die al eerder zijn behandeld. Door de prijsafspraken wordt het middel vanaf 1 september voor deze patiënten ook vergoed u...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

28-7-2018

Dringende Sicherheitsinformation zu Alcon 20GA TOTALPLUS Combined Procedure Pak von Alcon Laboratories, Inc.

Dringende Sicherheitsinformation zu Alcon 20GA TOTALPLUS Combined Procedure Pak von Alcon Laboratories, Inc.

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

20-9-2018

Folicombin®

Rote - Liste

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

22-8-2018

CLYNAV (Elanco GmbH)

CLYNAV (Elanco GmbH)

CLYNAV (Active substance: Salmon pancreas disease vaccine (recombinant DNA plasmid)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5624 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2390/T/02

Europe -DG Health and Food Safety

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

Europe - EMA - European Medicines Agency

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

7-8-2018

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Active substance: Recombinant Protein Q from L. infantum MON-1) - Centralised - Yearly update - Commission Decision (2018)5415 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Active substance: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23) - Transfer of orphan designation - Commission Decision (2018)5289 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/133/14/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1410 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1410 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1410 (Active substance: Recombinant human aspartylglucosaminidase) - Transfer of orphan designation - Commission Decision (2018)5051 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/911 (Chiesi Farmaceutici S.p.A.)

EU/3/11/911 (Chiesi Farmaceutici S.p.A.)

EU/3/11/911 (Active substance: Recombinant human galactocerebrosidase) - Transfer of orphan designation - Commission Decision (2018)5050 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/042/11/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/02/103 (Chiesi Farmaceutici S.p.A.)

EU/3/02/103 (Chiesi Farmaceutici S.p.A.)

EU/3/02/103 (Active substance: Recombinant Human Porphobilinogen Deaminase) - Transfer of orphan designation - Commission Decision (2018)5048 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/083/01/T/01

Europe -DG Health and Food Safety

18-7-2018

EU/3/16/1686 (Mereo Biopharma Ireland Ltd)

EU/3/16/1686 (Mereo Biopharma Ireland Ltd)

EU/3/16/1686 (Active substance: Recombinant humanised monoclonal IgG2 lambda antibody against human sclerostin) - Transfer of orphan designation - Commission Decision (2018)4809 of Wed, 18 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/16/T/02

Europe -DG Health and Food Safety