Mission [demande de renouvellement en cours]

Hauptinformation

  • Handelsname:
  • Mission [demande de renouvellement en cours]
  • INN (Internationale Bezeichnung):
  • Diquat
  • Darreichungsform:
  • SL Wasserlösliches Konzentrat
  • 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:
  • Mission [demande de renouvellement en cours]
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Herbizid

Weitere Informationen

Status

  • Quelle:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Zulassungsnummer:
  • W-6934
  • Letzte Änderung:
  • 15-11-2018

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

Handelsbezeichnung: Mission [demande de

renouvellement en cours]

Pflanzenschutzmittelverzeichnis (Stand: 06.11.2018)

Bewilligung beendet: Ausverkaufsfrist: 31.05.2018, Aufbrauchsfrist: 31.05.2019

Produktkategorie:

Bewilligungsinhaber:

Eidg. Zulassungsnummer:

Herbizid

United Phosphorus Switzerland Ltd.

W-6934

Stoff(e):

Gehalt:

Formulierungscode:

Wirkstoff: Diquat

17.2 % 200 g/l

[als 32.8% Diquat dibromid (381

g/l)]

SL Wasserlösliches Konzentrat

Anwendungen

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

B Beerenbau allg.

Dicotyledonen

(Unkräuter)

Konzentration: 0.4 %

Anwendung: In 300-1200 l Wasser/ha;

ab 1. Standjahr.

Kernobst

Steinobst

Dicotyledonen

(Unkräuter)

Konzentration: 0.4 %

Anwendung: In 300-1200 l Wasser/ha;

ab 1. Standjahr.

W Reben

Ackerwinde

Einjährige

Dicotyledonen

(Unkräuter)

Zaunwinde

Zweijährige Disteln

Konzentration: 0.4 %

Anwendung: In 300-1200 l Wasser/ha;

ab 1. Standjahr.

Karotten

Lauch

Nüsslisalat

Zwiebeln

Dicotyledonen

(Unkräuter)

Aufwandmenge: 3 l/ha

Anwendung: Vor dem Auflaufen der

Kulturen.

Speise- und

Futterkartoffeln

Desikkation, Abbrennen

Aufwandmenge: 3.6 - 4.8 l/ha

Anwendung: Hauptabbrennperiode.

Speise- und

Futterkartoffeln

Desikkation, Abbrennen

Aufwandmenge: 4.5 l/ha

Anwendung: Beginn der

Abbrennperiode.

Speise- und

Dicotyledonen

Aufwandmenge: 4 l/ha

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Futterkartoffeln [Früh-]

(Unkräuter)

Anwendung: Bei Auflaufen der

Unkräuter.

Wiesen und Weiden

Faden-Ehrenpreis

Aufwandmenge: 4 l/ha

Anwendung: Spätherbst, kurz nach

letzter Beweidung oder letztem Schnitt.

Bäume und Sträucher

(ausserhalb Forst)

Einjährige

Dicotyledonen

(Unkräuter)

Aufwandmenge: 4 - 5 l/ha

Anwendung: In 300-1200 l Wasser/ha.

1, 2

Auflagen und Bemerkungen:

Hinweis auf potentiellen Wiederaustrieb von mehrjährigen Unkräutern und Ungräsern.

Angabe der Kulturen und deren Verträglichkeit.

Gefahrenkennzeichnungen:

Zur Vermeidung von Risiken für Mensch und Umwelt ist die Gebrauchsanleitung einzuhalten.

R 20/22 Gesundheitsschädlich beim Einatmen und Verschlucken.

R 36/37/38 Reizt die Augen, die Atmungsorgane und die Haut.

R 43 Sensibilisierung durch Hautkontakt möglich.

R 48/25 Giftig: Gefahr ernster Gesundheitsschäden bei längerer Exposition durch Verschlucken.

R 50/53 Sehr giftig für Wasserorganismen, kann in Gewässern längerfristig schädliche Wirkungen

haben.

S 01/02 Unter Verschluss und für Kinder unzugänglich aufbewahren.

S 13 Von Nahrungsmitteln, Getränken und Futtermitteln fernhalten.

S 20/21 Bei der Arbeit nicht essen, trinken oder rauchen.

S 24 Berührung mit der Haut vermeiden.

S 36/37/39 Bei der Arbeit geeignete Schutzkleidung, Schutzhandschuhe und

Schutzbrille/Gesichtsschutz tragen.

S 45 Bei Unfall oder Unwohlsein sofort Arzt zuziehen (wenn möglich, dieses Etikett vorzeigen).

S 60 Dieses Produkt und sein Behälter sind als gefährlicher Abfall zu entsorgen.

S 61 Freisetzung in die Umwelt vermeiden. Besondere Anweisungen einholen /

Sicherheitsdatenblatt zu Rate ziehen.

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

SPo 2 Die gesamte Schutzkleidung muss nach Gebrauch gewaschen werden.

SPo 5 Bei der Anwendung in einem geschlossenen Raum (z.B. Gewächshaus) ist der behandelte

Raum vor dem Wiederbetreten [gründlich / oder Zeit angeben / bis zur Abtrocknung des

Spritzbelages] zu lüften.

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

Symbol

Gefahrenbezeichnung Umweltgefährlich Giftig

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.

23-3-2019

Umsetzung des Durchführungsbeschlusses der Europäischen Kommission zum PSUR Single Assessment betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Bortezomib vom 20.02.2019

Umsetzung des Durchführungsbeschlusses der Europäischen Kommission zum PSUR Single Assessment betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Bortezomib vom 20.02.2019

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

22-3-2019

Safety and efficacy of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species

Safety and efficacy of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species

Published on: Thu, 21 Mar 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‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). O...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Safety and efficacy of l‐tryptophan produced with Escherichia coli CGMCC 11674 for all animal species

Safety and efficacy of l‐tryptophan produced with Escherichia coli CGMCC 11674 for all animal species

Published on: Thu, 21 Mar 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 Escherichia coli CGMCC 11674 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain did not raise safety concerns. The FEEDAP Panel cannot conclude on the safety of l‐tryptophan produced ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

16-3-2019

Umsetzung des Durchführungsbeschlusses der Europäischen Kommission zum PSUR Single Assessment betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Efavirenz vom 18.02.2019

Umsetzung des Durchführungsbeschlusses der Europäischen Kommission zum PSUR Single Assessment betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff Efavirenz vom 18.02.2019

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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

12-3-2019

Geschäftsverteilungsplan der registrierten Ethik-Kommissionen für das Jahr 2019

Geschäftsverteilungsplan der registrierten Ethik-Kommissionen für das Jahr 2019

Geschäftsverteilungsplan Ethik-Kommissionen 2019

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

27-3-2019

Pemetrexed Accord (Accord Healthcare S.L.U.)

Pemetrexed Accord (Accord Healthcare S.L.U.)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1669 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4072/T/06

Europe -DG Health and Food Safety

20-3-2019

Listed and assessed listed medicines: Application and submission user guide

Listed and assessed listed medicines: Application and submission user guide

Guidance updated

Therapeutic Goods Administration - Australia

20-3-2019

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2145 of Wed, 20 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003817

Europe -DG Health and Food Safety

19-3-2019

Loxicom (Norbrook Laboratories (Ireland) Limited)

Loxicom (Norbrook Laboratories (Ireland) Limited)

Loxicom (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2179 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/141/T/32

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2155 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004764

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2154 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004730

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2153 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004734

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)2156 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004770

Europe -DG Health and Food Safety

19-3-2019

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Active substance: Lomitapide) - Transfer of orphan designation - Commission Decision (2019)2152 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004233

Europe -DG Health and Food Safety

18-3-2019

Today is the last day to provide comments on the draft guidance: Content of Premarket Submissions for Management of #Cybersecurity in #MedicalDevices. Submit comments here:  https://go.usa.gov/xE6jm  #DigitalHealth #HealthTechpic.twitter.com/EEyI1OErRY

Today is the last day to provide comments on the draft guidance: Content of Premarket Submissions for Management of #Cybersecurity in #MedicalDevices. Submit comments here: https://go.usa.gov/xE6jm  #DigitalHealth #HealthTechpic.twitter.com/EEyI1OErRY

Today is the last day to provide comments on the draft guidance: Content of Premarket Submissions for Management of #Cybersecurity in #MedicalDevices. Submit comments here: https://go.usa.gov/xE6jm  #DigitalHealth #HealthTech pic.twitter.com/EEyI1OErRY

FDA - U.S. Food and Drug Administration

18-3-2019

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2151 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003815

Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Active substance: Combretastatin A1 diphosphate) - Transfer of orphan designation - Commission Decision (2019)2149 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003811

Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2148 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003801

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2147 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003809

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Active substance: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha)) - Transfer of orphan designation - Commission Decision (2019)2146 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003818

Europe -DG Health and Food Safety

18-3-2019

EU/3/04/195 (Diamond ROC EOOD)

EU/3/04/195 (Diamond ROC EOOD)

EU/3/04/195 (Active substance: 2-Methoxy-5-[(1Z)-2-(3,4,5-trimethoxyphenyl)ethenyl]-phenol) - Transfer of orphan designation - Commission Decision (2019)2144 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003813

Europe -DG Health and Food Safety

18-3-2019

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (Active substance: Human coagulation factor X) - Transfer of orphan designation - Commission Decision (2019)2158 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004129

Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Active substance: Acebutolol hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2157 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004715

Europe -DG Health and Food Safety

15-3-2019

To better achieve our mission & vision, #FDA CDRH will undergo a reorganization to better integrate CDRH's premarket & postmarket program functions along product lines. The goal of the reorganization is to improve organizational efficiencies to better mee

To better achieve our mission & vision, #FDA CDRH will undergo a reorganization to better integrate CDRH's premarket & postmarket program functions along product lines. The goal of the reorganization is to improve organizational efficiencies to better mee

To better achieve our mission & vision, #FDA CDRH will undergo a reorganization to better integrate CDRH's premarket & postmarket program functions along product lines. The goal of the reorganization is to improve organizational efficiencies to better meet public health needs.

FDA - U.S. Food and Drug Administration

15-3-2019

Ongentys (Bial - Portela and Ca, SA)

Ongentys (Bial - Portela and Ca, SA)

Ongentys (Active substance: opicapone) - Centralised - Yearly update - Commission Decision (2019)2113 of Fri, 15 Mar 2019

Europe -DG Health and Food Safety

15-3-2019

Intrarosa (Endoceutics S.A.)

Intrarosa (Endoceutics S.A.)

Intrarosa (Active substance: prasterone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2063 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004138/T/0005

Europe -DG Health and Food Safety

15-3-2019

NovoMix (Novo Nordisk A/S)

NovoMix (Novo Nordisk A/S)

NovoMix (Active substance: Insulin aspart) - Centralised - 2-Monthly update - Commission Decision (2019)2114 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/000308/II/0095

Europe -DG Health and Food Safety

15-3-2019

Zoledronic acid Accord (Accord Healthcare S.L.U.)

Zoledronic acid Accord (Accord Healthcare S.L.U.)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2071 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002667/T/0007

Europe -DG Health and Food Safety

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

15-3-2019

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Active substance: Autologous adult live cultured osteoblasts) - Transfer of orphan designation - Commission Decision (2019)2105 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004280

Europe -DG Health and Food Safety

15-3-2019

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Active substance: Apomorphine hydrochloride (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)2115 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004495

Europe -DG Health and Food Safety

15-3-2019

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Active substance: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate) - Transfer of orphan designation - Commission Decision (2019)2107 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004914

Europe -DG Health and Food Safety

15-3-2019

EU/3/11/936 (BPL Bioproducts Laboratory GmbH)

EU/3/11/936 (BPL Bioproducts Laboratory GmbH)

EU/3/11/936 (Active substance: Human haptoglobin) - Transfer of orphan designation - Commission Decision (2019)2106 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004485

Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2111 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005192

Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Active substance: Exenatide) - Transfer of orphan designation - Commission Decision (2019)2110 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005191

Europe -DG Health and Food Safety

15-3-2019

EU/3/14/1396 (Boyd Consultants Limited)

EU/3/14/1396 (Boyd Consultants Limited)

EU/3/14/1396 (Active substance: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain) - Transfer of orphan designation - Commission Decision (2019)2109 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005074

Europe -DG Health and Food Safety

15-3-2019

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Active substance: Hydroxy-propyl-beta-cyclodextrin) - Transfer of orphan designation - Commission Decision (2019)2108 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005321

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

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Active substance: Fluoxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2089 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/T/31

Europe -DG Health and Food Safety

14-3-2019

Suprelorin (VIRBAC S.A.)

Suprelorin (VIRBAC S.A.)

Suprelorin (Active substance: Deslorelin acetate) - Centralised - Yearly update - Commission Decision (2019)2087 of Thu, 14 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Luminity (Lantheus EU Limited)

Luminity (Lantheus EU Limited)

Luminity (Active substance: perflutren) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2049 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/654/T/27

Europe -DG Health and Food Safety

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (Active substance: dinutuximab beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2061 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3918/T/10

Europe -DG Health and Food Safety

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Active substance: isavuconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2069 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2734/T/20

Europe -DG Health and Food Safety

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety

13-3-2019

Varuby (TESARO Bio Netherlands B.V.)

Varuby (TESARO Bio Netherlands B.V.)

Varuby (Active substance: rolapitant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2068 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4196/T/15

Europe -DG Health and Food Safety

13-3-2019

Senshio (Shionogi B.V.)

Senshio (Shionogi B.V.)

Senshio (Active substance: ospemifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2066 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2780/T/26

Europe -DG Health and Food Safety

13-3-2019

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (Active substance: melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2064 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425/T/04

Europe -DG Health and Food Safety

13-3-2019

Actrapid (Novo Nordisk A/S)

Actrapid (Novo Nordisk A/S)

Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2070 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Herceptin (Roche Registration GmbH)

Herceptin (Roche Registration GmbH)

Herceptin (Active substance: trastuzumab) - Centralised - Yearly update - Commission Decision (2019) 2059 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

INOmax (Linde Healthcare AB)

INOmax (Linde Healthcare AB)

INOmax (Active substance: Nitric oxide) - Centralised - Yearly update - Commission Decision (2019)2060 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

13-3-2019

Ferriprox (Apotex Europe B.V.)

Ferriprox (Apotex Europe B.V.)

Ferriprox (Active substance: Deferiprone) - Centralised - 2-Monthly update - Commission Decision (2019)2057 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/236/II/0126/G

Europe -DG Health and Food Safety

13-3-2019

Praluent (Sanofi-Aventis groupe)

Praluent (Sanofi-Aventis groupe)

Praluent (Active substance: alirocumab) - Centralised - 2-Monthly update - Commission Decision (2019)2058 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3882/II/0042

Europe -DG Health and Food Safety

13-3-2019

Updated GMP licence application e-forms

Updated GMP licence application e-forms

GMP Licence submission e-forms will be updated on the TBS portal from 15 March 2019 to support the revised fees and charges model

Therapeutic Goods Administration - Australia

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

11-3-2019

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (Active substance: Acamprosate calcium) - Transfer of orphan designation - Commission Decision (2019)1944 of Mon, 11 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004283

Europe -DG Health and Food Safety

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

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Active substance: Recombinant human antibody directed against misfolded human superoxide dismutase 1) - Transfer of orphan designation - Commission Decision (2019)1943 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004025

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Active substance: 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide) - Transfer of orphan designation - Commission Decision (2019)1953 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004132

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Active substance: Recombinant derivative of C3 transferase) - Transfer of orphan designation - Commission Decision (2019)1952 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004115

Europe -DG Health and Food Safety

8-3-2019

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Active substance: Reduced oxydised N-acetyl heparin) - Transfer of orphan designation - Commission Decision (2019)1951 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004452

Europe -DG Health and Food Safety