Ally SX

Hauptinformation

  • Handelsname:
  • Ally SX
  • Darreichungsform:
  • SG Wasserlösliches Granulat
  • 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:
  • Ally SX
    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-6284
  • Letzte Änderung:
  • 14-11-2018

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

Handelsbezeichnung: Ally SX

Pflanzenschutzmittelverzeichnis (Stand: 06.11.2018)

Bewilligung beendet: Ausverkaufsfrist: 07.08.2019, Aufbrauchsfrist: 07.08.2020

Produktkategorie:

Bewilligungsinhaber:

Eidg. Zulassungsnummer:

Herbizid

DuPont International Operations Sàrl.

W-6284

Stoff(e):

Gehalt:

Formulierungscode:

Wirkstoff: Metsulfuron-methyl

20 %

SG Wasserlösliches Granulat

Anwendungen

A

Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

F Sommergetreide

Einjährige Dicotyledonen

(Unkräuter)

Aufwandmenge: 25 g/ha

Anwendung: Im Frühjahr. Stadium 13-30

(BBCH).

F Wintergetreide

Einjährige Dicotyledonen

(Unkräuter)

Aufwandmenge: 40 g/ha

Anwendung: Stadium 13-30 (BBCH). Im

Frühjahr.

Auflagen und Bemerkungen:

Maximal 1 Behandlung pro Kultur.

Gefahrenkennzeichnungen:

Darf nicht in die Hände von Kindern gelangen.

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

einhalten.

H410 Sehr giftig für Wasserorganismen mit langfristiger Wirkung.

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

Signalwort:

Achtung

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

GHS09

Symbol

Gefahrenbezeichnung 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.

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

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

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

Published on: Tue, 05 Mar 2019 A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions is the subject of this assessment. The active substance is considered to be CLA (t10,c12) methyl ester (ME). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA previously issued an opinion on the safety and efficacy of the product, in which it could not conclude on the efficacy of this additive for sows for reproduction and for cows f...

Europe - EFSA - European Food Safety Authority EFSA Journal

6-3-2019

Caffeine

Caffeine

Caffeine is a substance naturally present in over 60 different plants, including coffee, kola nut, guarana and yerba maté. It is most commonly consumed in coffee and tea, but it is also found in energy drinks. ANSES recommends that consumers use moderation with regard to caffeine - especially children, pregnant women and individuals who are either sensitive to its effects or who suffer from certain pathologies.

France - Agence Nationale du Médicament Vétérinaire

1-3-2019

Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by <em>Salmonella</em>

Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by <em>Salmonella</em>

Springfield, OR, Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella.

FDA - U.S. Food and Drug Administration

1-3-2019

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

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

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

FDA - U.S. Food and Drug Administration

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) 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

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-2-2019

Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)

Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)

Published on: Thu, 14 Feb 2019 Following the submission of application EFSA‐GMO‐RX‐012 under Regulation (EC) No1829/2003 from BayerCropScienceN.V., the Panelon Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified oilseed rape T45, for food and feed uses, excluding cultivation within the European Unio...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-2-2019

Jurnista (hydromorphone hydrochloride) prolonged-release

Jurnista (hydromorphone hydrochloride) prolonged-release

Product defect correction - potentially damaged tablets

Therapeutic Goods Administration - Australia

20-3-2019


Amlodipine / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010434/201807

Amlodipine / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010434/201807

Amlodipine / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010434/201807

Europe - EMA - European Medicines Agency

20-3-2019


Domperidone: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0015

Domperidone: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0015

Domperidone: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0015

Europe - EMA - European Medicines Agency

19-3-2019


Fentanyl (transdermal patches, solution for injection - nationally authorised product only): List of nationally authorised medicinal products - PSUSA/00001370/201804

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): List of nationally authorised medicinal products - PSUSA/00001370/201804

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): List of nationally authorised medicinal products - PSUSA/00001370/201804

Europe - EMA - European Medicines Agency

19-3-2019


Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804

Europe - EMA - European Medicines Agency

18-3-2019


Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Europe - EMA - European Medicines Agency

18-3-2019


Inosine dimepranol acedoben: List of nationally authorised medicinal products - PSUSA/00010425/201808

Inosine dimepranol acedoben: List of nationally authorised medicinal products - PSUSA/00010425/201808

Inosine dimepranol acedoben: List of nationally authorised medicinal products - PSUSA/00010425/201808

Europe - EMA - European Medicines Agency

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


Miglitol: List of nationally authorised medicinal products - PSUSA/00002061/201807

Miglitol: List of nationally authorised medicinal products - PSUSA/00002061/201807

Miglitol: List of nationally authorised medicinal products - PSUSA/00002061/201807

Europe - EMA - European Medicines Agency

14-3-2019


Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201806

Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201806

Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201806

Europe - EMA - European Medicines Agency

14-3-2019


Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804

Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804

Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804

Europe - EMA - European Medicines Agency

13-3-2019


Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805

Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805

Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805

Europe - EMA - European Medicines Agency

12-3-2019


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

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

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

Europe - EMA - European Medicines Agency

11-3-2019


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

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

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

Europe - EMA - European Medicines Agency

6-3-2019


Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan), Treatment of granulomatosis with polyangiitis, 19/11/2014, Positive

Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan), Treatment of granulomatosis with polyangiitis, 19/11/2014, Positive

Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan), Treatment of granulomatosis with polyangiitis, 19/11/2014, Positive

Europe - EMA - European Medicines Agency

6-3-2019


Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide, Treatment of microscopic polyangiitis (avacopan), 19/11/2014, Positive

Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide, Treatment of microscopic polyangiitis (avacopan), 19/11/2014, Positive

Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide, Treatment of microscopic polyangiitis (avacopan), 19/11/2014, Positive

Europe - EMA - European Medicines Agency

28-2-2019

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

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

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

Europe -DG Health and Food Safety

28-2-2019

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

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

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

Europe -DG Health and Food Safety

28-2-2019

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

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

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

Europe -DG Health and Food Safety

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)

Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)

Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066), decision type: , therapeutic area: , PIP number: P/0183/2014

Europe - EMA - European Medicines Agency

25-2-2019

EU/3/18/2026 (Alnylam Netherlands B.V.)

EU/3/18/2026 (Alnylam Netherlands B.V.)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)1637 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/O...

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1619 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004220

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1620 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004218

Europe -DG Health and Food Safety

22-2-2019

EU/3/14/1363 (FarmaStrateegia OU)

EU/3/14/1363 (FarmaStrateegia OU)

EU/3/14/1363 (Active substance: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid) - Transfer of orphan designation - Commission Decision (2019)819 of Fri, 22 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002992

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: 2-Allyl-1-[6-(1-hydroxy-1-methylethyl)pyridin-2-yl]-6-{[4-(4-methylpiperazin-1-yl)phenyl]amino}-1,2-dihydro-3H-pyrazolo[3,4-d]pyrimidin-3-one, Treatment of ovarian cancer, 26/04/2012, Withdrawn

Orphan designation: 2-Allyl-1-[6-(1-hydroxy-1-methylethyl)pyridin-2-yl]-6-{[4-(4-methylpiperazin-1-yl)phenyl]amino}-1,2-dihydro-3H-pyrazolo[3,4-d]pyrimidin-3-one, Treatment of ovarian cancer, 26/04/2012, Withdrawn

Orphan designation: 2-Allyl-1-[6-(1-hydroxy-1-methylethyl)pyridin-2-yl]-6-{[4-(4-methylpiperazin-1-yl)phenyl]amino}-1,2-dihydro-3H-pyrazolo[3,4-d]pyrimidin-3-one, Treatment of ovarian cancer, 26/04/2012, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201806

Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201806

Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201806

Europe - EMA - European Medicines Agency

20-2-2019


Solifenacin / tamsulosin: List of nationally authorised medicinal products - PSUSA/00010285/201807

Solifenacin / tamsulosin: List of nationally authorised medicinal products - PSUSA/00010285/201807

Solifenacin / tamsulosin: List of nationally authorised medicinal products - PSUSA/00010285/201807

Europe - EMA - European Medicines Agency

20-2-2019


Calcitonin salmon, synthetic analogue of eel calcitonin: List of nationally authorised medicinal products - PSUSA/00000494/201806

Calcitonin salmon, synthetic analogue of eel calcitonin: List of nationally authorised medicinal products - PSUSA/00000494/201806

Calcitonin salmon, synthetic analogue of eel calcitonin: List of nationally authorised medicinal products - PSUSA/00000494/201806

Europe - EMA - European Medicines Agency

20-2-2019


Fosinopril, fosinopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00010463/201807

Fosinopril, fosinopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00010463/201807

Fosinopril, fosinopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00010463/201807

Europe - EMA - European Medicines Agency

20-2-2019


Pipobroman: List of nationally authorised medicinal products - PSUSA/00002427/201806

Pipobroman: List of nationally authorised medicinal products - PSUSA/00002427/201806

Pipobroman: List of nationally authorised medicinal products - PSUSA/00002427/201806

Europe - EMA - European Medicines Agency

20-2-2019


Dexchlorpheniramine: List of nationally authorised medicinal products - PSUSA/00000989/201806

Dexchlorpheniramine: List of nationally authorised medicinal products - PSUSA/00000989/201806

Dexchlorpheniramine: List of nationally authorised medicinal products - PSUSA/00000989/201806

Europe - EMA - European Medicines Agency

20-2-2019


Nimesulide (systemic formulations): List of nationally authorised medicinal products - PSUSA/00009236/201806

Nimesulide (systemic formulations): List of nationally authorised medicinal products - PSUSA/00009236/201806

Nimesulide (systemic formulations): List of nationally authorised medicinal products - PSUSA/00009236/201806

Europe - EMA - European Medicines Agency

20-2-2019


Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Europe - EMA - European Medicines Agency

20-2-2019


Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/20180

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/20180

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/20180

Europe - EMA - European Medicines Agency

20-2-2019


Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201807

Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201807

Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201807

Europe - EMA - European Medicines Agency

20-2-2019


Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Europe - EMA - European Medicines Agency

20-2-2019


Nilutamide: List of nationally authorised medicinal products - PSUSA/00002163/201807

Nilutamide: List of nationally authorised medicinal products - PSUSA/00002163/201807

Nilutamide: List of nationally authorised medicinal products - PSUSA/00002163/201807

Europe - EMA - European Medicines Agency

20-2-2019


Cefepime: List of nationally authorised medicinal products - PSUSA/00000593/201806

Cefepime: List of nationally authorised medicinal products - PSUSA/00000593/201806

Cefepime: List of nationally authorised medicinal products - PSUSA/00000593/201806

Europe - EMA - European Medicines Agency

20-2-2019


Tiagabine: List of nationally authorised medicinal products - PSUSA/00002942/201806

Tiagabine: List of nationally authorised medicinal products - PSUSA/00002942/201806

Tiagabine: List of nationally authorised medicinal products - PSUSA/00002942/201806

Europe - EMA - European Medicines Agency

20-2-2019


Phenylpropanolamine: List of nationally authorised medicinal products - PSUSA/00010483/201806

Phenylpropanolamine: List of nationally authorised medicinal products - PSUSA/00010483/201806

Phenylpropanolamine: List of nationally authorised medicinal products - PSUSA/00010483/201806

Europe - EMA - European Medicines Agency

20-2-2019


Pitavastatin: List of nationally authorised medicinal products -  PSUSA/00010502/201807

Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201807

Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201807

Europe - EMA - European Medicines Agency

20-2-2019


Rizatriptan: List of nationally authorised medicinal products - PSUSA/00002655/201806

Rizatriptan: List of nationally authorised medicinal products - PSUSA/00002655/201806

Rizatriptan: List of nationally authorised medicinal products - PSUSA/00002655/201806

Europe - EMA - European Medicines Agency

20-2-2019


Urapidil: List of nationally authorised medicinal products - PSUSA/00003078/201807

Urapidil: List of nationally authorised medicinal products - PSUSA/00003078/201807

Urapidil: List of nationally authorised medicinal products - PSUSA/00003078/201807

Europe - EMA - European Medicines Agency

19-2-2019


Aciclovir: List of nationally authorised medicinal products - PSUSA/00000048/201806

Aciclovir: List of nationally authorised medicinal products - PSUSA/00000048/201806

Aciclovir: List of nationally authorised medicinal products - PSUSA/00000048/201806

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid, Treatment of cystic fibrosis, 19/11/2014, Positive

Orphan designation: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid, Treatment of cystic fibrosis, 19/11/2014, Positive

Orphan designation: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid, Treatment of cystic fibrosis, 19/11/2014, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Oxycodone: List of nationally authorised medicinal products - PSUSA/00002254/201804

Oxycodone: List of nationally authorised medicinal products - PSUSA/00002254/201804

Oxycodone: List of nationally authorised medicinal products - PSUSA/00002254/201804

Europe - EMA - European Medicines Agency

18-2-2019


Nortriptyline: List of nationally authorised medicinal products - PSUSA/00002192/201803

Nortriptyline: List of nationally authorised medicinal products - PSUSA/00002192/201803

Nortriptyline: List of nationally authorised medicinal products - PSUSA/00002192/201803

Europe - EMA - European Medicines Agency

18-2-2019


Pelargonium sidoides dc and/or pelargonium reniforme curt. / radix: List of nationally authorised medicinal products - PSUSA/00002329/201806

Pelargonium sidoides dc and/or pelargonium reniforme curt. / radix: List of nationally authorised medicinal products - PSUSA/00002329/201806

Pelargonium sidoides dc and/or pelargonium reniforme curt. / radix: List of nationally authorised medicinal products - PSUSA/00002329/201806

Europe - EMA - European Medicines Agency

18-2-2019


Pholcodine / biclotymol / chlorphenamine maleate : List of nationally authorised medicinal products - PSUSA/00010437201804

Pholcodine / biclotymol / chlorphenamine maleate : List of nationally authorised medicinal products - PSUSA/00010437201804

Pholcodine / biclotymol / chlorphenamine maleate : List of nationally authorised medicinal products - PSUSA/00010437201804

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide, Treatment of cystic fibrosis, 21/05/2015, Positive

Orphan designation: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide, Treatment of cystic fibrosis, 21/05/2015, Positive

Orphan designation: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide, Treatment of cystic fibrosis, 21/05/2015, Positive

Europe - EMA - European Medicines Agency

8-2-2019


Pamidronate: List of nationally authorised medicinal products - PSUSA/00002269/201805

Pamidronate: List of nationally authorised medicinal products - PSUSA/00002269/201805

Pamidronate: List of nationally authorised medicinal products - PSUSA/00002269/201805

Europe - EMA - European Medicines Agency

8-2-2019


Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201805

Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201805

Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201805

Europe - EMA - European Medicines Agency