Nova>ProXX C

Hauptinformation

  • Handelsname:
  • Nova>ProXX C
  • 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:
  • Nova>ProXX C
    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-4177-1
  • Letzte Änderung:
  • 06-09-2017

Packungsbeilage

Produkt:

Handelsbezeichnung: Nova>ProXX C

Produktekategorie

Bewilligungsinhaber

Eidg. Zulassungsnummer

Herbizid

Otto Hauenstein Samen

W-4177-1

Stoff(e)

Gehalt

Formulierungscode

Wirkstoff: Mecoprop-P

33.8 % 405 g/l

SL Wasserlösliches

Konzentrat

Wirkstoff: 2,4-D

14.2 % 170 g/l

Beistoffe, zusätzlich zu deklarieren:

Dimethylamin

Anwendungen

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Kernobst

Steinobst

Dicotyledonen

(Unkräuter)

Aufwandmenge: 1.5 - 2.5 l/ha

F Getreide

Dicotyledonen

(Unkräuter) [inkl.

Galium]

Aufwandmenge: 1.5 - 2.5 l/ha

Anwendung: Zwischen

Bestocken und Schossen des

Getreides.

F Wiesen und Weiden

Distelarten

Weisser Germer

Teilwirkung:

Rumex-Arten

Konzentration: 10 %

Anwendung:

Einzelpflanzenbehandlung mit

Handspritzgeräten.

1, 2

F Wiesen und Weiden

Distelarten

Weisser Germer

Teilwirkung:

Rumex-Arten

Konzentration: 0.5 - 1 %

Anwendung:

Einzelpflanzenbehandlung mit

Rückenspritze.

1, 2

F Wiesen und Weiden

Distelarten

Weisser Germer

Teilwirkung:

Aufwandmenge: 1.5 - 2.5 l/ha

Anwendung:

Flächenbehandlung; vor

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Rumex-Arten

Neuansaat.

F Wiesen und Weiden

Giftige Kreuzkräuter

(Senecio spp.)

Konzentration: 0.5 - 1 %

Anwendung:

Einzelpflanzenbehandlung mit

Rückenspritze.

1, 2

F Wiesen und Weiden

Giftige Kreuzkräuter

(Senecio spp.)

Konzentration: 10 %

Anwendung:

Einzelpflanzenbehandlung mit

Handspritzgeräten.

1, 2

Z Zier- und Sportrasen

Dicotyledonen

(Unkräuter) [inkl.

Weissklee]

Aufwandmenge: 1.5 - 2 l/ha

Z Zier- und Sportrasen

Teilwirkung:

Ehrenpreis-Arten

Gundelrebe

Kriechender Günsel

Aufwandmenge: 1.5 - 2 l/ha

Böschungen und Grünstreifen

entlang von Verkehrswegen (gem.

ChemRRV)

Giftige Kreuzkräuter

(Senecio spp.)

Konzentration: 0.5 - 1 %

Anwendung:

Einzelpflanzenbehandlung mit

Rückenspritze.

1, 3

Böschungen und Grünstreifen

entlang von Verkehrswegen (gem.

ChemRRV)

Giftige Kreuzkräuter

(Senecio spp.)

Konzentration: 10 %

Anwendung:

Einzelpflanzenbehandlung mit

Handspritzgeräten.

1, 3

Auflagen und Bemerkungen:

Ansetzen der Spritzbrühe: Schutzhandschuhe + Schutzbrille oder Visier tragen.

Beweidung oder Schnitt (Grünfutter oder Konservierung) frühestens 3 Wochen nach der

Behandlung. Ausnahme: Für nicht laktierende Tiere beträgt die Wartefrist 2 Wochen.

Gemäss Chemikalien-Risikoreduktions-Verordnung (ChemRRV, Anhang 2.5): Nur

Einzelpflanzenbehandlung anderweitig nicht bekämpfbarer Problempflanzen auf Böschungen und

Grünstreifen entlang von Strassen und Gleisanlagen.

Gefahrenkennzeichnungen:

Darf nicht in die Hände von Kindern gelangen.

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

einhalten.

H302 Gesundheitsschädlich bei Verschlucken.

H317 Kann allergische Hautreaktionen verursachen.

H318 Verursacht schwere Augenschäden.

H335 Kann die Atemwege reizen.

H411 Giftig für Wasserorganismen, mit langfristiger Wirkung.

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

Signalwort:

Gefahr

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

GHS05 GHS07

GHS09

Symbol

Gefahrenbezeichnung Ätzend Vorsicht gefährlich Gewässergefährdend

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.

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

15-11-2017

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24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

29-8-2018

Mekinist (Novartis Europharm Limited)

Mekinist (Novartis Europharm Limited)

Mekinist (Active substance: trametinib) - Centralised - 2-Monthly update - Commission Decision (2018)5778 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2643/WS/1274

Europe -DG Health and Food Safety

27-8-2018

Kymriah (Novartis Europharm Limited)

Kymriah (Novartis Europharm Limited)

Kymriah (Active substance: tisagenlecleucel) - Centralised - Authorisation - Commission Decision (2018)5717 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4090

Europe -DG Health and Food Safety

1-8-2018

Arzerra (Novartis Europharm Limited)

Arzerra (Novartis Europharm Limited)

Arzerra (Active substance: Ofatumumab) - Centralised - Yearly update - Commission Decision (2018)5215 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ilaris (Novartis Europharm Limited)

Ilaris (Novartis Europharm Limited)

Ilaris (Active substance: Canakinumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5209 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1109/T/58

Europe -DG Health and Food Safety

30-7-2018

Aimovig (Novartis Europharm Limited)

Aimovig (Novartis Europharm Limited)

Aimovig (Active substance: erenumab) - Centralised - Authorisation - Commission Decision (2018)5102 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4447

Europe -DG Health and Food Safety

25-7-2018

Exjade (Novartis Europharm Limited)

Exjade (Novartis Europharm Limited)

Exjade (Active substance: deferasirox) - PSUSA - Modification - Commission Decision (2018)4986 of Wed, 25 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/939/201710

Europe -DG Health and Food Safety

11-7-2018

Seebri Breezhaler (Novartis Europharm Limited)

Seebri Breezhaler (Novartis Europharm Limited)

Seebri Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4513 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2430/T/27

Europe -DG Health and Food Safety

11-7-2018

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4526 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2690/T/30

Europe -DG Health and Food Safety

10-7-2018

Revolade (Novartis Europharm Limited)

Revolade (Novartis Europharm Limited)

Revolade (Active substance: Eltrombopag) - PSUSA - Modification - Commission Decision (2018)4487 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1205/201709

Europe -DG Health and Food Safety

10-7-2018

Hirobriz Breezhaler (Novartis Europharm Limited)

Hirobriz Breezhaler (Novartis Europharm Limited)

Hirobriz Breezhaler (Active substance: indacaterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4486 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1211/T/47

Europe -DG Health and Food Safety

10-7-2018

Visudyne (Novartis Europharm Limited)

Visudyne (Novartis Europharm Limited)

Visudyne (Active substance: verteporfin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4484 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/305/T/96

Europe -DG Health and Food Safety

4-7-2018

Enurev Breezhaler (Novartis Europharm Limited)

Enurev Breezhaler (Novartis Europharm Limited)

Enurev Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4342 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2691/T/27

Europe -DG Health and Food Safety

27-6-2018

Glivec (Novartis Europharm Limited)

Glivec (Novartis Europharm Limited)

Glivec (Active substance: Imatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4087 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/406/T/110

Europe -DG Health and Food Safety

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

Exforge (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4085 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/716/T/96

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

19-6-2018

Onbrez Breezhaler (Novartis Europharm Limited)

Onbrez Breezhaler (Novartis Europharm Limited)

Onbrez Breezhaler (Active substance: indacaterol) - Corrigendum - Commission Decision (2018)2573 of Tue, 19 Jun 2018

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety

11-6-2018

Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

Dafiro (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3753 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/776/T/99

Europe -DG Health and Food Safety

11-6-2018

Zykadia (Novartis Europharm Limited)

Zykadia (Novartis Europharm Limited)

Zykadia (Active substance: ceritinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3758 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3819/T/24

Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

Copalia (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3695 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/774/T/97

Europe -DG Health and Food Safety

5-6-2018

DuoTrav (Novartis Europharm Limited)

DuoTrav (Novartis Europharm Limited)

DuoTrav (Active substance: Travoprost / Timolol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3622 of Tue, 05 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/665/T/53

Europe -DG Health and Food Safety

4-6-2018

Votubia (Novartis Europharm Limited)

Votubia (Novartis Europharm Limited)

Votubia (Active substance: Everolimus) - Centralised - Variation - Commission Decision (2018)3624 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2311/X/45

Europe -DG Health and Food Safety

2-6-2018

EU/3/12/1046 (Novartis Europharm Limited)

EU/3/12/1046 (Novartis Europharm Limited)

EU/3/12/1046 (Active substance: Mavoglurant) - Transfer of orphan designation - Commission Decision (2018)3631 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/059/12/T/01

Europe -DG Health and Food Safety

2-6-2018

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Active substance: Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor) - Transfer of orphan designation - Commission Decision (2018)3630 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Novartis Europharm Limited)

EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)3397 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/02

Europe -DG Health and Food Safety

25-5-2018

Jakavi (Novartis Europharm Limited)

Jakavi (Novartis Europharm Limited)

Jakavi (Active substance: ruxolitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3272 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2464/T/35

Europe -DG Health and Food Safety

24-5-2018

Ultibro Breezhaler (Novartis Europharm Limited)

Ultibro Breezhaler (Novartis Europharm Limited)

Ultibro Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3259 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2679/R/24

Europe -DG Health and Food Safety

24-5-2018

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3265 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3755/R/27

Europe -DG Health and Food Safety

24-5-2018

Tyverb (Novartis Europharm Limited)

Tyverb (Novartis Europharm Limited)

Tyverb (Active substance: lapatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3273 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/795/T/52

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1745 (Novartis Europharm Limited)

EU/3/16/1745 (Novartis Europharm Limited)

EU/3/16/1745 (Active substance: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19) - Transfer of orphan designation - Commission Decision (2018)3146 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/087/16/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1266 (Novartis Europharm Limited)

EU/3/14/1266 (Novartis Europharm Limited)

EU/3/14/1266 (Active substance: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19) - Transfer of orphan designation - Commission Decision (2018)3145 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/187/13/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/06/375 (Novartis Europharm Limited)

EU/3/06/375 (Novartis Europharm Limited)

EU/3/06/375 (Active substance: Nilotinib) - Transfer of orphan designation - Commission Decision (2018)3033 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/06/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1382 (Novartis Europharm Limited)

EU/3/14/1382 (Novartis Europharm Limited)

EU/3/14/1382 (Active substance: Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist) - Transfer of orphan designation - Commission Decision (2018)3044 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/120/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1345 (Novartis Europharm Limited)

EU/3/14/1345 (Novartis Europharm Limited)

EU/3/14/1345 (Active substance: Osilodrostat) - Transfer of orphan designation - Commission Decision (2018)3043 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/13/1205 (Novartis Europharm Limited)

EU/3/13/1205 (Novartis Europharm Limited)

EU/3/13/1205 (Active substance: Human monoclonal antibody against human interleukin 13) - Transfer of orphan designation - Commission Decision (2018)3042 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/118/13/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Active substance: Panobinostat) - Transfer of orphan designation - Commission Decision (2018)3041 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Active substance: Humanised monoclonal antibody against P-selectin) - Transfer of orphan designation - Commission Decision (2018)3040 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/12/T/02

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/09/671 (Novartis Europharm Limited)

EU/3/09/671 (Novartis Europharm Limited)

EU/3/09/671 (Active substance: pasireotide) - Transfer of orphan designation - Commission Decision (2018)3037 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/052/09/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/09/670 (Novartis Europharm Limited)

EU/3/09/670 (Novartis Europharm Limited)

EU/3/09/670 (Active substance: pasireotide) - Transfer of orphan designation - Commission Decision (2018)3036 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/051/09/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Active substance: Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class) - Transfer of orphan designation - Commission Decision (2018)3035 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/059/08/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/06/391 (Novartis Europharm Limited)

EU/3/06/391 (Novartis Europharm Limited)

EU/3/06/391 (Active substance: Amphotericin B (for inhalation use)) - Transfer of orphan designation - Commission Decision (2018)3034 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/027/06/T/03

Europe -DG Health and Food Safety

16-5-2018

EU/3/04/214 (Novartis Europharm Limited)

EU/3/04/214 (Novartis Europharm Limited)

EU/3/04/214 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3032 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/028/04/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/03/140 (Novartis Europharm Limited)

EU/3/03/140 (Novartis Europharm Limited)

EU/3/03/140 (Active substance: Tobramycin (inhalation powder)) - Transfer of orphan designation - Commission Decision (2018)3031 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/072/02/T/02

Europe -DG Health and Food Safety

15-5-2018

Izba (Novartis Europharm Limited)

Izba (Novartis Europharm Limited)

Izba (Active substance: travoprost) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3002 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2738/T/10

Europe -DG Health and Food Safety

15-5-2018

Travatan (Novartis Europharm Limited)

Travatan (Novartis Europharm Limited)

Travatan (Active substance: Travoprost) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3001 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/390/T/59

Europe -DG Health and Food Safety

15-5-2018

Oslif Breezhaler (Novartis Europharm Limited)

Oslif Breezhaler (Novartis Europharm Limited)

Oslif Breezhaler (Active substance: indacaterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2999 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1210/T/45

Europe -DG Health and Food Safety

15-5-2018

Afinitor (Novartis Europharm Limited)

Afinitor (Novartis Europharm Limited)

Afinitor (Active substance: everolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3000 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1038/T/57

Europe -DG Health and Food Safety

15-5-2018

Tafinlar (Novartis Europharm Limited)

Tafinlar (Novartis Europharm Limited)

Tafinlar (Active substance: DABRAFENIB) - Centralised - Renewal - Commission Decision (2018)3010 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2604/R/30

Europe -DG Health and Food Safety

15-5-2018

Starlix (Novartis Europharm Limited)

Starlix (Novartis Europharm Limited)

Starlix (Active substance: nateglinide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3063 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/335/T/34

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

15-5-2018

Ulunar Breezhaler (Novartis Europharm Limited)

Ulunar Breezhaler (Novartis Europharm Limited)

Ulunar Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3058 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3875/T/24

Europe -DG Health and Food Safety

15-5-2018

Prometax (Novartis Europharm Limited)

Prometax (Novartis Europharm Limited)

Prometax (Active substance: Rivastigmine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2996 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/255/T/118

Europe -DG Health and Food Safety

3-5-2018

Atriance (Novartis Europharm Limited)

Atriance (Novartis Europharm Limited)

Atriance (Active substance: nelarabine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2780 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/752/T/41

Europe -DG Health and Food Safety

3-5-2018

Entresto (Novartis Europharm Limited)

Entresto (Novartis Europharm Limited)

Entresto (Active substance: sacubitril / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2779 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4062/T/18

Europe -DG Health and Food Safety

3-5-2018

Rydapt (Novartis Europharm Limited)

Rydapt (Novartis Europharm Limited)

Rydapt (Active substance: Midostaurin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2770 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4095/T/3

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2010 (Novartis Europharm Limited)

EU/3/18/2010 (Novartis Europharm Limited)

EU/3/18/2010 (Active substance: Branaplam) - Orphan designation - Commission Decision (2018)2406 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/249/17

Europe -DG Health and Food Safety