Nova>ProXX C

Hauptinformation

  • Handelsname:
  • Nova>ProXX C
  • 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:
  • 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:
  • 15-11-2018

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

Handelsbezeichnung: Nova>ProXX C

Pflanzenschutzmittelverzeichnis (Stand: 06.11.2018)

Produktkategorie:

Bewilligungsinhaber:

Eidg. Zulassungsnummer:

Herbizid

Otto Hauenstein Samen

W-4177-1

Stoff(e):

Gehalt:

Formulierungscode:

Wirkstoff: Mecoprop-P

Wirkstoff: 2,4-D

Beistoffe, zusätzlich zu deklarieren:

Dimethylamin

35.3 % 405 g/l

14.8 % 170 g/l

SL Wasserlösliches

Konzentrat

Anwendungen

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Kernobst

Steinobst

Einjährige Dicotyledonen

(Unkräuter)

Mehrjährige

Dicotyledonen (Unkräuter)

Aufwandmenge: 1.5 - 2.5 l/ha

1, 2

F Getreide

Einjährige Dicotyledonen

(Unkräuter) [inkl. Galium]

Mehrjährige

Dicotyledonen (Unkräuter)

[inkl. Galium]

Aufwandmenge: 1.5 - 2.5 l/ha

Anwendung: Zwischen

Bestocken und Schossen des

Getreides.

1, 2

F Wiesen und Weiden

Distelarten

Weisser Germer

Teilwirkung:

Rumex-Arten

Konzentration: 10 %

Anwendung:

Einzelpflanzenbehandlung mit

Handspritzgeräten.

1, 2, 3

F Wiesen und Weiden

Distelarten

Weisser Germer

Teilwirkung:

Rumex-Arten

Konzentration: 0.5 - 1 %

Anwendung:

Einzelpflanzenbehandlung mit

Rückenspritze.

1, 2, 3

F Wiesen und Weiden

Distelarten

Weisser Germer

Teilwirkung:

Rumex-Arten

Aufwandmenge: 1.5 - 2.5 l/ha

Anwendung:

Flächenbehandlung; vor

Neuansaat.

1, 2

F Wiesen und Weiden

Giftige Kreuzkräuter

(Senecio spp.)

Konzentration: 0.5 - 1 %

Anwendung:

Einzelpflanzenbehandlung mit

1, 2, 3

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Rückenspritze.

F Wiesen und Weiden

Giftige Kreuzkräuter

(Senecio spp.)

Konzentration: 10 %

Anwendung:

Einzelpflanzenbehandlung mit

Handspritzgeräten.

1, 2, 3

Z Zier- und Sportrasen

Teilwirkung:

Ehrenpreis-Arten

Gundelrebe

Kriechender Günsel

Aufwandmenge: 1.5 - 2 l/ha

1, 2, 4

Z Zier- und Sportrasen

Einjährige Dicotyledonen

(Unkräuter) [inkl.

Weissklee]

Mehrjährige

Dicotyledonen (Unkräuter)

[inkl. Weissklee]

Aufwandmenge: 1.5 - 2 l/ha

1, 2, 4

Böschungen und Grünstreifen

entlang von Verkehrswegen

(gem. ChemRRV)

Giftige Kreuzkräuter

(Senecio spp.)

Konzentration: 10 %

Anwendung:

Einzelpflanzenbehandlung mit

Handspritzgeräten.

1, 2, 5

Böschungen und Grünstreifen

entlang von Verkehrswegen

(gem. ChemRRV)

Giftige Kreuzkräuter

(Senecio spp.)

Konzentration: 0.5 - 1 %

Anwendung:

Einzelpflanzenbehandlung mit

Rückenspritze.

1, 2, 5

Auflagen und Bemerkungen:

Ansetzen der Spritzbrühe: Schutzhandschuhe + Schutzbrille oder Visier tragen.

Keine Anwendung, wenn ungeschützte Personen der Drift ausgesetzt sein könnten.

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

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

Nach Ausbringung des Mittels während 48h sicherstellen, dass niemand die behandelte Fläche

betritt.

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.

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

10-9-2018

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

OTTAWA –Health Canada is sharing the results of its review of potential long-term health effects involving valsartan drugs that were found to contain the impurity N-nitrosodimethylamine (NDMA). Health Canada scientists have assessed the available data to determine the potential increased risk of developing cancer, to help put the risk into context for Canadians.

Health Canada

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

9-7-2018

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Health Canada

23-6-2018

Dringende Sicherheitsinformation zu Perceval Sutureless Aortic Valve von LivaNova Canada Corp.

Dringende Sicherheitsinformation zu Perceval Sutureless Aortic Valve von LivaNova Canada Corp.

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

19-12-2018


Orphan designation: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate, Treatment of glioma, 24/08/2018, Positive

Orphan designation: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate, Treatment of glioma, 24/08/2018, Positive

Orphan designation: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

28-11-2018

GILENYA (Novartis Europharm Limited)

GILENYA (Novartis Europharm Limited)

GILENYA (Active substance: Fingolimod) - Centralised - Variation - Commission Decision (2018)7969 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2202/X/44

Europe -DG Health and Food Safety

19-10-2018

New Safety Communication. @US_FDA   is sharing Updated Information To Reduce Potential Cardiac Surgery   Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More:  https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

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

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

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