Cerumenex

Hauptinformation

  • Handelsname:
  • Cerumenex Tropfen
  • Darreichungsform:
  • Tropfen
  • Zusammensetzung:
  • oleoyl hydrolyzed animal protein 87 mg, propylenglycolum, excipiens ad solutionem pro 1 g.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Cerumenex Tropfen
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Entfernung von Ohrschmalz

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 28747
  • Berechtigungsdatum:
  • 14-11-1963
  • Letzte Änderung:
  • 24-10-2018

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

Patienteninformation

Cerumenex®

Mundipharma Medical Company

Was ist Cerumenex und wann wird es angewendet?

Cerumenex erweicht und löst verfestigte Pfropfen von Ohrenschmalz. Es dringt zwischen das

Ohrenschmalz und die Gehörgangwand ein.

Cerumenex wird angewendet zum Entfernen von verfestigtem Ohrenschmalz aus dem Gehörgang,

z.B. bei Verschluss oder teilweisem Verschluss des äusseren Gehörgangs und vor ohrenärztlichen

Untersuchungen, Behandlungen und Eingriffen.

Was sollte dazu beachtet werden?

Cerumenex ist zum einmaligen Gebrauch mit anschliessender Spülung bestimmt.

Aufgeweichte Ohrenschmalzpfropfen durch Spülung mit Wasser entfernen, und nicht mit harten

Gegenständen wie z.B. Wattestäbchen.

Wann darf Cerumenex nicht angewendet werden?

Bei Ohrenentzündungen, bei perforiertem Trommelfell, bei Hauterkrankungen (z.B. Ekzemen) im

Gehörgang und in der Ohrmuschel, bei Allergie auf einen der Inhaltsstoffe.

Cerumenex darf nicht zur Behandlung von Ohrenschmerzen verwendet werden.

Wann ist bei der Anwendung von Cerumenex Vorsicht geboten?

Falls Sie auf Seifen mit allergischen Hautreaktionen reagieren, sollte vor der Anwendung von

Cerumenex die lokale Verträglichkeit abgeklärt werden.

Bei zu langer Einwirkungszeit kann Cerumenex im Ohrenbereich Irritationen auslösen. Ein

Überschreiten der Einwirkungszeit von 30 Minuten muss deshalb vermieden werden.

Bei Auftreten von Überempfindlichkeitsreaktionen (z.B. Hautausschlag, Hautrötung, Juckreiz,

Schwellungen im Bereich des Gesichts oder des Nasen-Rachen-Raumes, Atembeschwerden) ist das

Arzneimittel abzusetzen und ein Arzt bzw. eine Ärztin aufzusuchen.

Bei gleichzeitigem Auftreten von Schwindel ist ein Arzt bzw. eine Ärztin aufzusuchen.

Bei Versagen der Therapie ist ein Arzt bzw. eine Ärztin aufzusuchen.

Informieren Sie Ihren Arzt, Apotheker oder Drogisten bzw. Ihre Ärztin, Apothekerin oder Drogistin,

wenn Sie an anderen Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch

selbstgekaufte) einnehmen oder äusserlich anwenden!

Darf Cerumenex während einer Schwangerschaft oder in der Stillzeit angewendet werden?

Aufgrund der bisherigen Erfahrungen ist bei bestimmungsgemässer Anwendung kein Risiko für das

Kind bekannt. Systematische wissenschaftliche Untersuchungen wurden aber nie durchgeführt.

Vorsichtshalber sollten Sie während der Schwangerschaft und Stillzeit möglichst auf Arzneimittel

verzichten oder den Arzt, Apotheker oder Drogisten bzw. die Ärztin, Apothekerin oder Drogistin um

Rat fragen.

Wie verwenden Sie Cerumenex?

Mehrere Tropfen Cerumenex mit Hilfe der im Flaschendeckel enthaltenen Pipette bei schräg

gehaltenem Kopf in den Gehörgang einträufeln. Gehörgang mit einem Wattebausch verschliessen.

Nach 20–30 Minuten den erweichten Pfropfen mit reichlich lauwarmem Wasser unter wenig Druck

ausspülen. Keine harten Gegenstände wie Wattestäbchen usw. verwenden.

Ist das Ergebnis nicht zufriedenstellend, darf das Verfahren am gleichen Tag höchstens einmal

wiederholt werden.

Cerumenex muss unbedingt nach jeder Behandlung gut ausgespült werden. Zu häufige Anwendung

oder zu langes Einwirken können Reizungen auslösen.

Es ist wichtig, versehentlich neben dem Gehörgang auf die Haut gelangtes oder aus dem Ohr

herauslaufendes Cerumenex gut mit Wasser abzuwaschen.

Bei Kindern darf Cerumenex nur auf ärztliche Verschreibung angewendet werden.

Halten Sie sich an die in der Packungsbeilage angegebene oder vom Arzt oder der Ärztin

verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so

sprechen Sie mit Ihrem Arzt, Apotheker oder Drogisten bzw. mit Ihrer Ärztin, Apothekerin oder

Drogistin.

Welche Nebenwirkungen kann Cerumenex haben?

Selten können lokale Hautreizungen, von milden entzündlichen Rötungen der Haut und Juckreiz des

äusseren Gehörgangs bis zu schweren ekzemartigen Reaktionen des gesamten Ohrenbereichs,

auftreten.

In Einzelfällen können Überempfindlichkeitsreaktionen auftreten, die sich äussern mit

Hautausschlag, Hautrötung, Juckreiz oder Schwellungen im Bereich des Gesichts oder des Nasen-

Rachen-Raumes.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt,

Apotheker oder Drogisten bzw. Ihre Ärztin, Apothekerin oder Drogistin informieren.

Was ist ferner zu beachten?

Für Kinder unzugänglich aufbewahren.

Bei Raumtemperatur (15–25 °C) lagern.

Nicht einnehmen. Bei versehentlicher Einnahme, insbesondere durch Kinder, ist sofort der Arzt/die

Ärztin zu benachrichtigen.

Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet

werden.

Weitere Auskünfte erteilt Ihnen Ihr Arzt, Apotheker oder Drogist bzw. Ihre Ärztin, Apothekerin oder

Drogistin. Diese Personen verfügen über die ausführliche Fachinformation.

Was ist in Cerumenex enthalten?

Wirkstoff: 87 mg Ölsäure-Polypeptid-Kondensat pro 1 g.

Hilfsstoffe: Propylenglykol, Trometamol.

Zulassungsnummer

28747 (Swissmedic).

Wo erhalten Sie Cerumenex? Welche Packungen sind erhältlich?

In Apotheken und Drogerien, ohne ärztliche Verschreibung.

Flaschen zu 10 ml mit Tropfpipette.

Zulassungsinhaberin

Mundipharma Medical Company, Hamilton/Bermuda, Zweigniederlassung Basel.

Diese Packungsbeilage wurde im März 2012 letztmals durch die Arzneimittelbehörde (Swissmedic)

geprüft.

21-3-2019

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Published on: Wed, 20 Mar 2019 The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be establ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Resources for Animal Food Producers in Flooded Central & Southern Plains of U.S.

Resources for Animal Food Producers in Flooded Central & Southern Plains of U.S.

FDA’s Center for Veterinary Medicine reminds animal food producers who may be affected by extreme weather and flooding in the Central and Southern Plains of the United States and who may be harvesting, mixing, storing or distributing grains and other foods for animals about information resources available.

FDA - U.S. Food and Drug Administration

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Probiotic Lactina® for chickens and rabbits

Probiotic Lactina® for chickens and rabbits

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the European Food Safety Authority Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Probiotic Lactina® for chickens for fattening and rabbits. The additive is a preparation containing viable cells of six strains of lactic acid bacteria intended for use in feed at the proposed dose of 2.5 × 109CFU/kg complete feedingstuffs. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Assessment of the application for renewal of authorisation of Bonvital® (Enterococcus faecium DSM 7134) as a feed additive for weaned piglets and pigs for fattening

Assessment of the application for renewal of authorisation of Bonvital® (Enterococcus faecium DSM 7134) as a feed additive for weaned piglets and pigs for fattening

Published on: Tue, 19 Mar 2019 Bonvital® is the trade name for a feed additive based on Enterococcus faecium DSM 7134 currently authorised for use in piglets, pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. This opinion concerns the renewal of the authorisation of Bonvital® as a zootechnical additive for weaned piglets and pigs for fattening. The applicant is proposing to increase the minimum and maximum inclusion level of the additive in feed for ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-3-2019

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

Roger Genet, Director General of ANSES, and David Alis, President of the University of Rennes 1, today signed a scientific framework agreement aimed at strengthening their cooperation on environmental health, focused primarily on the "One Health" concept covering human, animal and plant health for the benefit of all. To mark this occasion, a conference and round table were organised on the theme of the exposome, one of the key issues at the heart of this new partnership between the two institutions.  

France - Agence Nationale du Médicament Vétérinaire

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

Published on: Tue, 12 Mar 2019 In 2017, the EFSA Panel on Additive and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Probion Forte®(Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) as a feed additive for chickens for fattening. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment provided that the identity of the strains is established and the lack ...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019

Data sources on animal diseases:Country Card of Denmark

Data sources on animal diseases:Country Card of Denmark

Published on: Thu, 07 Mar 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019

Safety and efficacy of Actisaf® Sc47 (Saccharomyces cerevisiae CNCM I‐4407) as a feed additive for cattle for fattening, dairy cows, weaned piglets and sows

Safety and efficacy of Actisaf® Sc47 (Saccharomyces cerevisiae CNCM I‐4407) as a feed additive for cattle for fattening, dairy cows, weaned piglets and sows

Published on: Thu, 07 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Actisaf® Sc47 for dairy cows, cattle for fattening, weaned piglets and sows when used as a zootechnical additive. Actisaf® Sc47 consists of viable cells of a strain Saccharomyces cerevisiae and is marketed in three formulations. The FEEDAP Panel considers that the three ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and two lots of Ivermax® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in ...

FDA - U.S. Food and Drug Administration

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

Published on: Tue, 05 Mar 2019 A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions is the subject of this assessment. The active substance is considered to be CLA (t10,c12) methyl ester (ME). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA previously issued an opinion on the safety and efficacy of the product, in which it could not conclude on the efficacy of this additive for sows for reproduction and for cows f...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of l‐valine produced using Corynebacterium glutamicum CGMCC 11675 for all animal species

Safety and efficacy of l‐valine produced using Corynebacterium glutamicum CGMCC 11675 for all animal species

Published on: Mon, 04 Mar 2019 The product subject of this assessment is l‐valine produced by fermentation with a strain of Corynebacterium glutamicum (CGMCC 11675). It is intended to be used in feed and water for drinking for all animal species and categories. Owing to the uncertainties regarding the possible genetic modification of the original production strain, the FEEDAP Panel cannot conclude on the safety of the additive l‐valine produced with C. glutamicum CGMCC 11675 for the target species, the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Published on: Fri, 01 Mar 2019 Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detecte...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Published on: Fri, 01 Mar 2019 The additive Calsporin® is a preparation of viable spores of Bacillus subtilis DSM 15544, at a minimum declared concentration of 1 × 1010 colony forming units (CFU)/g additive. The additive is authorised as a zootechnical additive (functional group: gut flora stabiliser) for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, laying hens and ornamental fish, dogs, in sows and in suckli...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species

Published on: Thu, 28 Feb 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation with a genetically modified strain of Escherichia coli CGMCC 7.248 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli CGMCC 7.248 and its recombinant DNA were not detected in the f...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species

Safety and efficacy of l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species

Published on: Thu, 28 Feb 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ when used as a nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l‐threonine produced by fermentation with a ■■■■■ strain of C. glutamicum (■■■■■). l‐Threo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of Bonvital (Enterococcus faecium, DSM 7134) as an additive in water for drinking for sows

Safety and efficacy of Bonvital (Enterococcus faecium, DSM 7134) as an additive in water for drinking for sows

Published on: Thu, 28 Feb 2019 The additive Bonvital is a preparation of Enterococcus faecium authorised in feed for piglets and pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. The current authorisation in sows does not include the use of the additive in water for drinking. The additive is intended for use in water for drinking for sows at a minimum level of 2.5 × 108 colony forming unit (CFU)/L. This level is half of that minimum authorised in com...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-2-2019

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2017

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2017

Published on: Tue, 26 Feb 2019 The data on antimicrobial resistance in zoonotic and indicator bacteria in 2017, submitted by 28 EU Member States (MSs), were jointly analysed by EFSA and ECDC. Resistance in zoonotic Salmonella and Campylobacter from humans, animals and food, and resistance in indicator Escherichia coli as well as meticillin-resistant Staphylococcus aureus in animals and food were addressed, and temporal trends assessed. ‘Microbiological’ resistance was assessed using epidemiological cut-...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

ANSES and CIRAD strengthen their scientific cooperation dedicated to "One Health"

ANSES and CIRAD strengthen their scientific cooperation dedicated to "One Health"

At the Paris International Agricultural Show today, Roger Genet, Director General of ANSES, and Michel Eddi, President Managing Director of CIRAD, signed a five-year framework partnership agreement. The two organisations are thus strengthening their numerous existing collaborations to improve knowledge of pathogens and pests and their vectors in the fields of animal health, plant health and food.

France - Agence Nationale du Médicament Vétérinaire

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

Published on: Fri, 22 Feb 2019 This report describes the tasks performed in the period 1/3/2017 to 27/11/2018 under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 on toxicological studies and animal feeding studies included in applications for market authorisation of genetically modified feed/plants under Regulation (EC) No 1829/2003. The tasks cover the check for study adherence to relevant EFSA guidance documents and to OECD Test Guideline no 407 (1995/2008), OECD Test Guideline no 408 (1998) and OECD P...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Sweden

Data sources on animal diseases: Country Card of Sweden

Published on: Mon, 18 Feb 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Slovakia

Data sources on animal diseases: Country Card of Slovakia

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspo...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Finland

Data sources on animal diseases: Country Card of Finland

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Czech Republic

Data sources on animal diseases: Country Card of Czech Republic

Published on: Mon, 18 Feb 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Italy

Data sources on animal diseases: Country Card of Italy

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspon...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-2-2019

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Published on: Fri, 15 Feb 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 (AfB1) binder for all animal species; the additive is composed of bentonite feed grade and algae belonging to Ulva spp. The European Commission request follows an opinion of the FEEDAP Panel published in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-2-2019


Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Categorisation of antimicrobials

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Categorisation of antimicrobials

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Categorisation of antimicrobials

Europe - EMA - European Medicines Agency

5-2-2019

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

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

Published on: Mon, 04 Feb 2019 The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to new residue trials for globe artichokes and beans with pods and for storage stability data in products of animal origin were addressed. Further risk mana...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety and efficacy of l‐valine produced by fermentation using Corynebacterium glutamicum KCCM 11201P for all animal species

Safety and efficacy of l‐valine produced by fermentation using Corynebacterium glutamicum KCCM 11201P for all animal species

Published on: Thu, 31 Jan 2019 The product subject of this assessment is l‐valine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (KCCM 11201P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations below thresholds specified by EFSA, thus C. glutamicum KCCM 11201P may be considered safe by the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Manual for reporting on zoonoses and zoonotic agents, within the framework of Directive 2003/99/EC, and on some other pathogenic microbiological agents for information derived from the year 2018

Manual for reporting on zoonoses and zoonotic agents, within the framework of Directive 2003/99/EC, and on some other pathogenic microbiological agents for information derived from the year 2018

Published on: Wed, 30 Jan 2019 This reporting manual provides guidance to Member States (MSs) for reporting on zoonoses and zoonotic agents in animals, food and feed under the framework of Directive 2003/99/EC and also on the reporting of other pathogenic microbiological agents in food. The objective of this manual is to harmonise and streamline reporting by MSs to ensure that the data collected are relevant and comparable for analysis at the European Union (EU) level. This manual covers all the zoonose...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

User manual for mapping Member State zoonoses standard terminology to EFSA standard terminology for information derived from the year 2018

User manual for mapping Member State zoonoses standard terminology to EFSA standard terminology for information derived from the year 2018

Published on: Wed, 30 Jan 2019 The European Food Safety Authority (EFSA) is tasked with coordinating the reporting of zoonoses, zoonotic agents, animal populations, antimicrobial resistance and food‐borne outbreaks in the European Union (EU) under Directive 2003/99/EC, as well as analysing and summarising the data collected. For data transmission purposes, EFSA created a simple Microsoft Office Excel‐based mapping tool to allow Member States to map their standard terminology to EFSA's standard terminolo...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Manual for reporting on antimicrobial resistance within the framework of Directive 2003/99/EC and Decision 2013/652/EU for information derived from the year 2018

Manual for reporting on antimicrobial resistance within the framework of Directive 2003/99/EC and Decision 2013/652/EU for information derived from the year 2018

Published on: Wed, 30 Jan 2019 This manual provides guidance for reporting antimicrobial resistance under the framework of Directive 2003/99/EC and Commission Implementing Decision 2013/652/EU in food‐producing animals and foodstuffs derived thereof. The objective is to harmonise and streamline the reporting made by the Member States to ensure that the antimicrobial resistance data collected are relevant and easy to analyse at the European Union level. Detailed guidelines are provided for the reporting ...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Data dictionaries‐guidelines for reporting 2018 data on zoonoses, antimicrobial resistance and food‐borne outbreaks

Data dictionaries‐guidelines for reporting 2018 data on zoonoses, antimicrobial resistance and food‐borne outbreaks

Published on: Wed, 30 Jan 2019 This technical report of the European Food Safety Authority (EFSA) presents guidance to reporting European Union (EU) Member States and non‐Member States in data submission using extensible markup language (XML) data transfer covering the reporting of isolate‐based quantitative antimicrobial resistance data, as well as reporting of prevalence data on zoonoses and food‐borne contaminants, food‐borne outbreak data, animal population data and disease status data. For data col...

Europe - EFSA - European Food Safety Authority EFSA Journal

29-1-2019

Purina Animal Nutrition Voluntarily Recalling Purina® Honor® Show Chow® Showlamb Grower Due to Elevated Copper Level

Purina Animal Nutrition Voluntarily Recalling Purina® Honor® Show Chow® Showlamb Grower Due to Elevated Copper Level

)– Purina Animal Nutrition is voluntarily recalling two lots of Purina® Honor® Show Chow® Showlamb Grower due to elevated copper levels. The feed is packaged in purple branded Purina Honor Show Chow bags.

FDA - U.S. Food and Drug Administration

26-1-2019

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

Published on: Fri, 25 Jan 2019 The European Food Safety Authority (EFSA) received the mandate from the European Commission (EC), in accordance with Article 31 of Regulation (EC) No. 178/2002, to collect data on the molecular testing of food‐borne pathogens such as Salmonella, Listeria monocytogenes and Shiga toxin‐producing Escherichia coli (STEC) from food, feed, animals and the related environment, to contribute to the epidemiological investigations of food‐borne outbreaks and to the identification of...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Published on: Fri, 25 Jan 2019 Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 “In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants”. To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and cri...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Overview of available toxicity data for calystegines

Overview of available toxicity data for calystegines

Published on: Fri, 25 Jan 2019 Calystegines are polyhydroxylated nortropane alkaloids that have been found in various solanaceous foods, in particular in potatoes and aubergines. The biological activity and potential toxicity of calystegines are associated with their capacity to inhibit glycosidases and block carbohydrate metabolism inducing lysosomal storage toxicity. The present report summarises the retrieved information on the possible toxicity of calystegines. Only few in vivo short‐term toxicologi...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-3-2019

EU/3/14/1249 (Akcea Therapeutics Ireland Limited)

EU/3/14/1249 (Akcea Therapeutics Ireland Limited)

EU/3/14/1249 (Active substance: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III) - Transfer of orphan designation - Commission Decision (2019)2104 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004954

Europe -DG Health and Food Safety

14-3-2019

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (Active substance: Tylvalosin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2091 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/83/T/77

Europe -DG Health and Food Safety

14-3-2019


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

1-3-2019

EU/3/15/1563 (TMC Pharma (EU) Limited)

EU/3/15/1563 (TMC Pharma (EU) Limited)

EU/3/15/1563 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2019)1751 of Fri, 01 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003921

Europe -DG Health and Food Safety

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Triheptanoin, Treatment of mitochondrial trifunctional protein deficiency, 28/07/2015, Positive

Orphan designation: Triheptanoin, Treatment of mitochondrial trifunctional protein deficiency, 28/07/2015, Positive

Orphan designation: Triheptanoin, Treatment of mitochondrial trifunctional protein deficiency, 28/07/2015, Positive

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Orphan designation: Recombinant megakaryopoiesis-stimulating protein, Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

12-2-2019

Vectra Felis (Ceva SantE Animale)

Vectra Felis (Ceva SantE Animale)

Vectra Felis (Active substance: dinotefuran, pyriproxyfen) - Centralised - Renewal - Commission Decision (2019)1096 of Tue, 12 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2746/R/08

Europe -DG Health and Food Safety

5-2-2019


Risk classification of antimicrobials used in animals opens for public consultation

Risk classification of antimicrobials used in animals opens for public consultation

Risk classification of antimicrobials used in animals opens for public consultation

Europe - EMA - European Medicines Agency

4-2-2019

EU/3/16/1758 (Clinical Network Services (NL) B.V.)

EU/3/16/1758 (Clinical Network Services (NL) B.V.)

EU/3/16/1758 (Active substance: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide) - Transfer of orphan designation - Commission Decision (2019)816 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003048

Europe -DG Health and Food Safety

4-2-2019

Respreeza (CSL Behring GmbH)

Respreeza (CSL Behring GmbH)

Respreeza (Active substance: human alpha1-proteinase inhibitor) - Centralised - Yearly update - Commission Decision (2019)842 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor (TBX-1400), decision type: , therapeutic area: , PIP number: P/0284/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Serotype 26 adenovirus encoding mosaic 1 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos1.Gag-Pol) / serotype 26 adenovirus encoding mosaic 2 HIV-1 group-specific antigen and polym

Opinion/decision on a Paediatric investigation plan (PIP): Serotype 26 adenovirus encoding mosaic 1 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos1.Gag-Pol) / serotype 26 adenovirus encoding mosaic 2 HIV-1 group-specific antigen and polym

Opinion/decision on a Paediatric investigation plan (PIP): Serotype 26 adenovirus encoding mosaic 1 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos1.Gag-Pol) / serotype 26 adenovirus encoding mosaic 2 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos2.Gag-Pol) / serotype 26 adenovirus encoding mosaic 1 HIV-1 envelope protein (Ad26.Mos1.Env) / serotype 26 adenovirus encoding mosaic 2S HIV-1 envelope protein (Ad26.Mos2S.Env) [Ad26.Mos4.HIV], decision type: , therapeutic area: ,...

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision t

Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision t

Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision type: , therapeutic area: , PIP number: P/0318/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C / trimeric, recombinant HIV-1 envelope glycoprotein 140 containing motifs of multiple HIV-1 variants, adjuvanted with aluminium ph

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C / trimeric, recombinant HIV-1 envelope glycoprotein 140 containing motifs of multiple HIV-1 variants, adjuvanted with aluminium ph

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C / trimeric, recombinant HIV-1 envelope glycoprotein 140 containing motifs of multiple HIV-1 variants, adjuvanted with aluminium phosphate [Clade C gp140/ Mosaic gp140], decision type: , therapeutic area: , PIP number: P/0237/2018

Europe - EMA - European Medicines Agency