Topik 15 WP

Hauptinformation

  • Handelsname:
  • Topik 15 WP
  • 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.


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Lokalisierung

  • Erhältlich in:
  • Topik 15 WP
    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-5613
  • Letzte Änderung:
  • 06-09-2017

Packungsbeilage

Produkt:

Handelsbezeichnung: Topik 15 WP

Produktekategorie

Bewilligungsinhaber Eidg. Zulassungsnummer

Herbizid

Syngenta Agro AG

W-5613

Stoff(e)

Gehalt

Formulierungscode

Wirkstoff: Clodinafop-

propargyl

15 %

WP Wasserdispergierbares Pulver

Wirkstoff: Cloquintocet-mexyl

3.75 %

Anwendungen

A Kultur

Schaderreger/Wirkung

Dosierungshinweise

Auflagen

Sommerroggen

Sommerweize

Einjährige Monocotyledonen (Ungräser)

Aufwandmenge: 0.3 - 0.6

kg/ha

Triticale

Winterroggen

Winterweizen

Einjährige Monocotyledonen (Ungräser)

Aufwandmenge: 0.4 - 0.6

kg/ha

Gefahrenkennzeichnungen:

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

R 36 Reizt die Augen.

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

haben.

S 02 Darf nicht in die Hände von Kindern gelangen.

S 13 Von Nahrungsmitteln, Getränken und Futtermitteln fernhalten.

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

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

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

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

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

Gefahrensymbole und -bezeichnungen:

Kurzkennzeichnung

Symbol

Gefahrenbezeichnung Umweltgefährlich Reizend

Im Zweifelsfall gelten einzig die Originaldokumente der Zulassung. Die Erwähnung eines Produktes,

Wirkstoffes oder einer Firma stellt keine Empfehlung dar und bedeutet nicht, dass sich das Produkt im

Verkauf befindet.

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

Recently Updated Records for the Week of October 17, 2018 Last Modified Date: Monday, October 15, 2018

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

23-8-2018

Rote-Hand-Brief zu THIOPENTAL ROTEXMEDICA 500 mg und THIOPENTAL ROTEXMEDICA 1000 mg vom 15.08.2018

Rote-Hand-Brief zu THIOPENTAL ROTEXMEDICA 500 mg und THIOPENTAL ROTEXMEDICA 1000 mg vom 15.08.2018

Rote-Hand-Brief zu THIOPENTAL ROTEXMEDICA 500 mg und THIOPENTAL ROTEXMEDICA 1000 mg

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-8-2018

Enforcement Report for the Week of August 15, 2018

Enforcement Report for the Week of August 15, 2018

Recently Updated Records for the Week of August 15, 2018 Last Modified Date: Monday, August 13, 2018

FDA - U.S. Food and Drug Administration

14-8-2018

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte neemt woensdagmiddag 15 augustus 2018 deel aan de herdenking van de capitulatie van Japan op 15 augustus 1945. De herdenking vindt plaats bij het Indisch Monument in Den Haag.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

9-8-2018

Stronghold Plus ad us. vet. 15 mg / 2,5 mg, Loesung zum Auftropfen fuer Katzen

Stronghold Plus ad us. vet. 15 mg / 2,5 mg, Loesung zum Auftropfen fuer Katzen

● Die Neuzulassung erfolgte am 09.08.2018.

Institut für Veterinärpharmakologie und toxikologie

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

27-7-2018

Dringende Sicherheitsinformation zu VIDAS CA 15-3 von bioMérieux S. (Marcy- l'Etoile)

Dringende Sicherheitsinformation zu VIDAS CA 15-3 von bioMérieux S. (Marcy- l'Etoile)

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

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

18-7-2018

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

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

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

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

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

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

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

Europe -DG Health and Food Safety

15-8-2018

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

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

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

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Agopton® 15 mg/30 mg Kapseln

Rote - Liste

30-7-2018

Xarelto® 15 mg Filmtabletten

Rote - Liste

27-7-2018

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

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

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

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

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

Europe -DG Health and Food Safety

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4080 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/287/14/T/01

Europe -DG Health and Food Safety