Isonet-E

Hauptinformation

  • Handelsname:
  • Isonet-E
  • Darreichungsform:
  • VP Verdampfende Wirkstoffe enthaltendes Produkt
  • Verwenden für:
  • Pflanzen
  • Art der Medizin:
  • Agrochemisch

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:
  • Isonet-E
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Insektizid (Insektenlockstoff, Pheromon)

Weitere Informationen

Status

  • Quelle:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Zulassungsnummer:
  • W-6161
  • Letzte Änderung:
  • 15-11-2018

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

Handelsbezeichnung: Isonet-E

Pflanzenschutzmittelverzeichnis (Stand: 06.11.2018)

Produktkategorie:

Bewilligungsinhaber:

Eidg. Zulassungsnummer:

Insektizid (Insektenlockstoff,

Pheromon)

Andermatt Biocontrol

W-6161

Stoff(e):

Gehalt:

Formulierungscode:

Wirkstoff: Z9-12 Ac

[220 mg / Dispenser]

VP Verdampfende Wirkstoffe enthaltendes

Produkt

Anwendungen

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

W Reben

Einbindiger Traubenwickler

Aufwandmenge: 500 Dispenser/ha

Anwendung: Vor Flugbeginn.

1, 2, 3

Auflagen und Bemerkungen:

Gute Isolation (mindestens 100 m von unbehandelten Beständen).

Anlagegrösse nicht unter 1-2 ha.

Bei der Handhabung und beim Aufhängen der Dispensoren sind Schutzhandschuhe zu tragen.

Gefahrenkennzeichnungen:

Darf nicht in die Hände von Kindern gelangen.

EUH 401 Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung

einhalten.

H315 Verursacht Hautreizungen.

H412 Schädlich für Wasserorganismen, mit langfristiger Wirkung.

SP 1 Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen.

Signalwort:

Achtung

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

GHS07

Symbol

Gefahrenbezeichnung Vorsicht gefährlich

Im Zweifelsfall gelten einzig die Originaldokumente der Zulassung. Die Erwähnung eines Produktes,

Wirkstoffes oder einer Firma stellt keine Empfehlung dar und bedeutet nicht, dass sich das Produkt im

Verkauf befindet.

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

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

15-3-2019

Peer review of the pesticide risk assessment of the active substance thiacloprid

Peer review of the pesticide risk assessment of the active substance thiacloprid

Published on: Thu, 14 Mar 2019 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiaclopr...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Enforcement Report for the Week of March 13, 2019

Enforcement Report for the Week of March 13, 2019

Recently Updated Records for the Week of March 13, 2019 Last Modified Date: Tuesday, March 12, 2019

FDA - U.S. Food and Drug Administration

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

Published on: Tue, 12 Mar 2019 The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well‐defined fungal species and reliable methods exist for its detection and identification. It is present in south‐western USA, northern Mexico, Libya and Venezuela. The pest is not...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

Published on: Tue, 12 Mar 2019 An outbreak of 32 Salmonella enterica serotype Poona cases in infants and young children has recently been identified in France (30 cases), Belgium (one case) and Luxembourg (one case). All 32 patients were infected with the same bacterial strain based on core genome multilocus sequence typing analysis. All patients had onset of symptoms between August 2018 and February 2019. Information from interviews was available for 30 patients. All consumed one of three rice-based in...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

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

12-3-2019


Agenda - PRAC draft agenda of meeting 12-15 March 2019

Agenda - PRAC draft agenda of meeting 12-15 March 2019

Agenda - PRAC draft agenda of meeting 12-15 March 2019

Europe - EMA - European Medicines Agency

9-3-2019

Umsetzung der einstimmigen Beschlüsse der Koordinierungsgruppe EMA/CMDh/46887/2016 vom 27.01.2016 und EMA/CMDh/852733/2018 vom 13.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Oxaliplatin

Umsetzung der einstimmigen Beschlüsse der Koordinierungsgruppe EMA/CMDh/46887/2016 vom 27.01.2016 und EMA/CMDh/852733/2018 vom 13.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Oxaliplatin

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Oxaliplatin der Europäischen PSUR Single Assessment Verfahren nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

9-3-2019

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/850991/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Oxycodon

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/850991/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Oxycodon

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Oxycodon infolge des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

8-3-2019

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/848776/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Deoxycholsäure

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/848776/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Deoxycholsäure

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Deoxycholsäure infolge des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

8-3-2019

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/835435/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Nortriptylin

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/835435/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Nortriptylin

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Nortriptylin infolge des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

1-3-2019

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial proc...

FDA - U.S. Food and Drug Administration

23-2-2019

Umsetzung der einstimmigen Beschlüsse der Koordinierungsgruppe EMA/CMDh /439088/2017 vom 19.07.2017 und EMA/CMDh /848760/2018 vom 12.12.2018  betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Isotretinoin (orale Darreichungsformen)

Umsetzung der einstimmigen Beschlüsse der Koordinierungsgruppe EMA/CMDh /439088/2017 vom 19.07.2017 und EMA/CMDh /848760/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Isotretinoin (orale Darreichungsformen)

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Isotretinoin (orale Darreichungsformen) infolge der Europäischen PSUR Single Assessment Verfahren nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

23-2-2019

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/846726/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Nadroparin

Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe EMA/CMDh/846726/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Nadroparin

Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Nadroparin infolge des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

21-2-2019

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Published on: Wed, 20 Feb 2019 The EFSA Scientific Network for Risk Assessment of GMOs (the GMO Network) was established in accordance with EFSA's strategy for cooperation and networking with Member States. The goals of the GMO Network are to improve dialogue among members, build mutual understanding of risk assessment principles, enhance knowledge and confidence in the scientific assessment carried out in the EU, and increase the transparency of the process among Member States and EFSA. The annual repo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-2-2019

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 12 Feb 2019 According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance. Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified 13 active substances for which a review of MRLs i...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019


Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Lomitapide, Treatment of familial chylomicronaemia, 17/12/2010, Positive

Orphan designation: Lomitapide, Treatment of familial chylomicronaemia, 17/12/2010, Positive

Orphan designation: Lomitapide, Treatment of familial chylomicronaemia, 17/12/2010, Positive

Europe - EMA - European Medicines Agency

15-3-2019


Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Europe - EMA - European Medicines Agency

15-3-2019


Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Europe - EMA - European Medicines Agency

15-3-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole, Treatment of sudden sensorineural hearing loss, 14/12/2018, Positive

Orphan designation: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole, Treatment of sudden sensorineural hearing loss, 14/12/2018, Positive

Orphan designation: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole, Treatment of sudden sensorineural hearing loss, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use (Active substance: nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequine) - Community Referrals - Art 31 - Commission Decision (2019)2050 of Tue, 12 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1452/C/2789

Europe -DG Health and Food Safety

12-3-2019


Orphan designation: 6,8-bis(benzylthio)octanoic acid, Treatment of acute myeloid leukaemia, 14/12/2018, Positive

Orphan designation: 6,8-bis(benzylthio)octanoic acid, Treatment of acute myeloid leukaemia, 14/12/2018, Positive

Orphan designation: 6,8-bis(benzylthio)octanoic acid, Treatment of acute myeloid leukaemia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid, Treatment of biliary atresia, 14/12/2018, Positive

Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid, Treatment of biliary atresia, 14/12/2018, Positive

Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid, Treatment of biliary atresia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: Pevonedistat, Treatment of myelodysplastic syndromes, 14/12/2018, Positive

Orphan designation: Pevonedistat, Treatment of myelodysplastic syndromes, 14/12/2018, Positive

Orphan designation: Pevonedistat, Treatment of myelodysplastic syndromes, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

12-3-2019


Orphan designation: Marizomib, Treatment of glioma, 14/12/2019, Positive

Orphan designation: Marizomib, Treatment of glioma, 14/12/2019, Positive

Orphan designation: Marizomib, Treatment of glioma, 14/12/2019, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Lonafarnib, Treatment of Hutchinson-Gilford progeria, 14/12/2018, Positive

Orphan designation: Lonafarnib, Treatment of Hutchinson-Gilford progeria, 14/12/2018, Positive

Orphan designation: Lonafarnib, Treatment of Hutchinson-Gilford progeria, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 14/12/2018, Positive

Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 14/12/2018, Positive

Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 14/12/2018, 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

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019


Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Acetylcysteine, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Orphan designation: Acetylcysteine, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Orphan designation: Acetylcysteine, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Venglustat, Treatment of autosomal dominant polycystic kidney disease, 14/12/2018, Positive

Orphan designation: Venglustat, Treatment of autosomal dominant polycystic kidney disease, 14/12/2018, Positive

Orphan designation: Venglustat, Treatment of autosomal dominant polycystic kidney disease, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Bromelain, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Orphan designation: Bromelain, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Orphan designation: Bromelain, Treatment of pseudomyxoma peritonei, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: afatinib, Treatment of Fanconi anaemia, 14/12/2018, Positive

Orphan designation: afatinib, Treatment of Fanconi anaemia, 14/12/2018, Positive

Orphan designation: afatinib, Treatment of Fanconi anaemia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019


Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019


Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor, Treatment of cystic fibrosis, 14/12/2018, Pos

Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor, Treatment of cystic fibrosis, 14/12/2018, Pos

Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor, Treatment of cystic fibrosis, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019


Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/19/2134 (FGK Representative Service GmbH)

EU/3/19/2134 (FGK Representative Service GmbH)

EU/3/19/2134 (Active substance: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester) - Orphan designation - Commission Decision (2019)1726 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002279

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1750 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004372

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1749 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004369

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1748 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004343

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2019)1626 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003556

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2019)1634 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003636

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Active substance: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1627 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003485

Europe -DG Health and Food Safety

22-2-2019


Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin,adeno-associated viral vector containing a rhodopsin gene, Treatment of rhodopsin-linked retinitis pigmentosa, 17/12/2010, Withdrawn

Orphan designation: Adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin,adeno-associated viral vector containing a rhodopsin gene, Treatment of rhodopsin-linked retinitis pigmentosa, 17/12/2010, Withdrawn

Orphan designation: Adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin,adeno-associated viral vector containing a rhodopsin gene, Treatment of rhodopsin-linked retinitis pigmentosa, 17/12/2010, Withdrawn

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (Active substance: Recombinant human lecithin cholesterol acyltransferase) - Transfer of orphan designation - Commission Decision (2019)1365 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003174

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (Active substance: Modified recombinant human C-type natriuretic peptide) - Transfer of orphan designation - Commission Decision (2019)1348 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003587

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1089 (Alexion Europe SAS)

EU/3/12/1089 (Alexion Europe SAS)

EU/3/12/1089 (Active substance: Choline tetrathiomolybdate) - Transfer of orphan designation - Commission Decision (2019)1373 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003805

Europe -DG Health and Food Safety

14-2-2019

Oxis® Turbohaler 12 Mikrogramm

Rote - Liste

13-2-2019


Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Europe - EMA - European Medicines Agency