Dasul Extra 6 OD

Hauptinformation

  • Handelsname:
  • Dasul Extra 6 OD
  • 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:
  • Dasul Extra 6 OD
    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-6497
  • Letzte Änderung:
  • 06-09-2017

Packungsbeilage

Produkt:

Handelsbezeichnung: Dasul Extra 6 OD

Produktekategorie

Bewilligungsinhaber

Eidg. Zulassungsnummer

Herbizid

ISK Biosciences (Schweiz) GmbH W-6497

Stoff(e)

Gehalt

Formulierungscode

Wirkstoff:

Nicosulfuron

6.2 % 60 g/l

OD Öldispersion

Anwendungen

A KulturSchaderreger/Wirkung

Dosierungshinweise

Auflagen

F Mais

Einjährige Dicotyledonen

(Unkräuter)

Einjährige Monocotyledonen

(Ungräser)

Teilwirkung:

Gemeine Quecke

Aufwandmenge: 0.75 l/ha

Anwendung: In 200-400 l Wasser. Früher Nachauflauf;

2-4- maximal 6-Blattstadium.

Auflagen und Bemerkungen:

Auf der Gebrauchsanweisung ist die Liste der Sorten aufzuführen, welche das Präparat vertragen.

Gefahrenkennzeichnungen:

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

R 36 Reizt die Augen.

R 43 Sensibilisierung durch Hautkontakt möglich.

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

haben.

S 02 Darf nicht in die Hände von Kindern gelangen.

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 26 Bei Berührung mit den Augen sofort gründlich mit Wasser abspülen und Arzt konsultieren.

S 35 Abfälle und Behälter müssen in gesicherter Weise beseitigt werden.

S 36/37 Bei der Arbeit geeignete Schutzhandschuhe und Schutzkleidung tragen.

S 46 Bei Verschlucken sofort ärztlichen Rat einholen und Verpackung oder Etikett vorzeigen.

S 57 Zur Vermeidung einer Kontamination der Umwelt geeigneten Behälter verwenden.

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

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

Symbol

Gefahrenbezeichnung Umweltgefährlich Reizend

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.

18-7-2018

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Staatssecretaris Paul Blokhuis (VWS) wil het aantal zelfmoorden en zelfmoordpogingen terugdringen. Om dat te bereiken geeft hij structureel 2 miljoen per jaar extra instellingssubsidie aan 113Zelfmoordpreventie. Het jaarlijkse budget van de organisatie gaat daarmee fors omhoog, van 3,4 miljoen naar 5,4 miljoen euro. Daarnaast zijn er extra middelen voor andere lopende activiteiten zoals de lokale aanpakken suïcidepreventie en onderzoek. In totaal is daar 15 miljoen mee gemoeid.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-7-2018

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

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

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

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-6-2018

Bruins bereikt onderhandelaarsakkoord huisartsen 2019-2022

Bruins bereikt onderhandelaarsakkoord huisartsen 2019-2022

Minister Bruno Bruins voor Medische Zorg en Sport heeft een onderhandelaarsakkoord bereikt met partijen uit de huisartszorg. De komende jaren wordt  € 471 miljoen beschikbaar gesteld voor het versterken van de huisartsenzorg. Dit budget is onder andere beschikbaar om meer tijd te hebben voor en met de patiënt, de zorg in de avond-, nacht- en weekenduren, het versterken van de organisatiegraad van de eerste lijn, de zorg voor kwetsbare groepen en  ICT-infrastructuur. Huisartsen(organisaties) en verzekeraa...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-6-2018

Nationaal Sportakkoord ondertekend

Nationaal Sportakkoord ondertekend

Ruim 700 extra buurtsportcoaches, verhoging van de onbelaste vrijwilligersvergoeding van €1500 naar €1700 euro per jaar, €87 miljoen aan subsidie voor sportverenigingen die investeren in accommodaties, een nieuwe code goed sportbestuur en beweegprogramma’s voor kinderen onder de 6 jaar. Dit is slechts een greep uit het sportakkoord dat minister Bruno Bruins (Sport)heeft gesloten met de sport, gemeenten en maatschappelijke organisaties en bedrijven. Het is de eerste keer dat zoveel partijen zijn samengebr...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

13-8-2018

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Active substance: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast) - Orphan designation - Commission Decision (2018)5277 of Mon, 13 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/028/18

Europe -DG Health and Food Safety

7-8-2018

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

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

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

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1756 (Kyowa Kirin Holdings B.V.)

EU/3/16/1756 (Kyowa Kirin Holdings B.V.)

EU/3/16/1756 (Active substance: Mogamulizumab) - Transfer of orphan designation - Commission Decision (2018)5404 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1694 (GlaxoSmithKline Trading Services Limited)

EU/3/16/1694 (GlaxoSmithKline Trading Services Limited)

EU/3/16/1694 (Active substance: Autologous CD4+ and CD8+ T-cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1) - Transfer of orphan designation - Commission Decision (2018)5405 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1683 (Worphmed Srl)

EU/3/16/1683 (Worphmed Srl)

EU/3/16/1683 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5407 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1682 (Worphmed Srl)

EU/3/16/1682 (Worphmed Srl)

EU/3/16/1682 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5406 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/1996 (Worphmed Srl)

EU/3/18/1996 (Worphmed Srl)

EU/3/18/1996 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5409 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/227/17/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1755 (Worphmed Srl)

EU/3/16/1755 (Worphmed Srl)

EU/3/16/1755 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5408 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/16/T/01

Europe -DG Health and Food Safety

4-8-2018

EU/3/18/2053 (Lakeside Regulatory Consulting Services Ltd)

EU/3/18/2053 (Lakeside Regulatory Consulting Services Ltd)

EU/3/18/2053 (Active substance: Tamibarotene) - Orphan designation - Commission Decision (2018)5285 of Sat, 04 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/18

Europe -DG Health and Food Safety

3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (Active substance: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene) - Orphan designation - Commission Decision (2018)5274 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2054 (Mallinckrodt Specialty Pharmaceuticals Ireland Limited)

EU/3/18/2054 (Mallinckrodt Specialty Pharmaceuticals Ireland Limited)

EU/3/18/2054 (Active substance: Tetracosactide) - Orphan designation - Commission Decision (2018)5286 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/043/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Active substance: Liposomal mannose-1-phosphate) - Orphan designation - Commission Decision (2018)5279 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/055/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Active substance: Givinostat) - Orphan designation - Commission Decision (2018)5278 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/062/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (Active substance: Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded) - Orphan designation - Commission Decision (2018)5276 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/023/18

Europe -DG Health and Food Safety

2-8-2018

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

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

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

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety

2-8-2018

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

EU/3/18/2052 (Dicerna EU 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) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2050 (AstraZeneca AB)

EU/3/18/2050 (AstraZeneca AB)

EU/3/18/2050 (Active substance: Selumetinib) - Orphan designation - Commission Decision (2018)5282 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/045/18

Europe -DG Health and Food Safety

2-8-2018

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

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

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

Europe -DG Health and Food Safety

2-8-2018

EU/3/16/1660 (Orchard Therapeutics Ltd)

EU/3/16/1660 (Orchard Therapeutics Ltd)

EU/3/16/1660 (Active substance: Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene) - Transfer of orphan designation - Commission Decision (2018)5288 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/024/16/T/02

Europe -DG Health and Food Safety

2-8-2018

EU/3/07/446 (Orchard Therapeutics Ltd)

EU/3/07/446 (Orchard Therapeutics Ltd)

EU/3/07/446 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA) - Transfer of orphan designation - Commission Decision (2018)5287 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/06/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/890 (Kowa Pharmaceutical Europe GmbH)

EU/3/11/890 (Kowa Pharmaceutical Europe GmbH)

EU/3/11/890 (Active substance: Peretinoin) - Transfer of orphan designation - Commission Decision (2018)5056 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/11/T/01

Europe -DG Health and Food Safety

27-7-2018

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

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

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

Europe -DG Health and Food Safety

27-7-2018

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

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

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

Europe -DG Health and Food Safety

27-7-2018

EU/3/18/2019 (Reata UK Limited)

EU/3/18/2019 (Reata UK Limited)

EU/3/18/2019 (Active substance: Bardoxolone methyl) - Transfer of orphan designation - Commission Decision (2018)5055 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/18/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Active substance: 4-[131I]iodo-L-phenylalanine) - Transfer of orphan designation - Commission Decision (2018)5036 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/05/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5043 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/158/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/924 (Celgene Europe B.V.)

EU/3/11/924 (Celgene Europe B.V.)

EU/3/11/924 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5044 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/078/11/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/09/672 (Celgene Europe B.V.)

EU/3/09/672 (Celgene Europe B.V.)

EU/3/09/672 (Active substance: Pomalidomide) - Transfer of orphan designation - Commission Decision (2018)5041 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/053/09/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/07/494 (Celgene Europe B.V.)

EU/3/07/494 (Celgene Europe B.V.)

EU/3/07/494 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5039 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/068/07/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/04/192 (Celgene Europe B.V.)

EU/3/04/192 (Celgene Europe B.V.)

EU/3/04/192 (Active substance: 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione) - Transfer of orphan designation - Commission Decision (2018)5040 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/083/03/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1263 (bluebird bio (Germany) GmbH)

EU/3/14/1263 (bluebird bio (Germany) GmbH)

EU/3/14/1263 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5035 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/13/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

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 (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

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 (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/18/2013 (Roche Registration GmbH)

EU/3/18/2013 (Roche Registration GmbH)

EU/3/18/2013 (Active substance: Polatuzumab vedotin) - Transfer of orphan designation - Commission Decision (2018)5054 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/231/17/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Camurus AB)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)5047 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/03

Europe -DG Health and Food Safety

27-7-2018

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

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

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

Europe -DG Health and Food Safety

27-7-2018

EU/3/13/1127 (Pfizer Europe MA EEIG)

EU/3/13/1127 (Pfizer Europe MA EEIG)

EU/3/13/1127 (Active substance: Inotuzumab ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5046 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/194/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene) - Transfer of orphan designation - Commission Decision (2018)5062 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/014/12/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Active substance: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate) - Transfer of orphan designation - Commission Decision (2018)5038 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/06/T/03

Europe -DG Health and Food Safety

27-7-2018

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Active substance: Gemtuzumab Ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5037 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/022/00/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1295 (Celgene Europe B.V.)

EU/3/14/1295 (Celgene Europe B.V.)

EU/3/14/1295 (Active substance: Marizomib) - Transfer of orphan designation - Commission Decision (2018)5063 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/035/14/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Active substance: tafamidis) - Transfer of orphan designation - Commission Decision (2018)5066 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/420 (Pfizer Europe MA EEIG)

EU/3/06/420 (Pfizer Europe MA EEIG)

EU/3/06/420 (Active substance: Temsirolimus) - Transfer of orphan designation - Commission Decision (2018)5065 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/058/06/T/02

Europe -DG Health and Food Safety

19-7-2018

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2018)4839 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/128/12/T/02

Europe -DG Health and Food Safety

19-7-2018

EU/3/16/1783 (Reglntel Ltd)

EU/3/16/1783 (Reglntel Ltd)

EU/3/16/1783 (Active substance: N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide) - Transfer of orphan designation - Commission Decision (2018)4810 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/138/16/T/02

Europe -DG Health and Food Safety

18-7-2018

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

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

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

Europe -DG Health and Food Safety

18-7-2018

EU/3/16/1718 (Salzman Group Ltd)

EU/3/16/1718 (Salzman Group Ltd)

EU/3/16/1718 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4807 of Wed, 18 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/16/T/01

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2030 (Biophytis)

EU/3/18/2030 (Biophytis)

EU/3/18/2030 (Active substance: 20-hydroxyecdysone) - Orphan designation - Commission Decision (2018)4175 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/18

Europe -DG Health and Food Safety

29-6-2018

EU/3/07/505 (Faron Pharmaceuticals Limited)

EU/3/07/505 (Faron Pharmaceuticals Limited)

EU/3/07/505 (Active substance: Interferon beta) - Amendment of orphan designation - Commission Decision (2018)4186 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/080/17

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2038 (PPD Global Ltd)

EU/3/18/2038 (PPD Global Ltd)

EU/3/18/2038 (Active substance: Palovarotene) - Orphan designation - Commission Decision (2018)4183 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/025/18

Europe -DG Health and Food Safety