Endex 19

Hauptinformation

  • Handelsname:
  • Endex® 19,5% ad us. vet., orale Suspension
  • Darreichungsform:
  • 5% ad us. vet., orale Suspension
  • Verwenden für:
  • Tiere
  • Art der Medizin:
  • allopathic Droge

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:
  • Endex® 19,5% ad us. vet., orale Suspension
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Oral anwendbares Breitband-Anthelminthikum gegen Nematoden und Leberegelbefall bei Rindern

Weitere Informationen

Status

  • Quelle:
  • Institut für Veterinärpharmakologie
  • Zulassungsnummer:
  • 51377
  • Letzte Änderung:
  • 03-11-2018

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

Endex

19,5% ad us. vet., orale Suspension

Elanco Tiergesundheit AG

Oral anwendbares Breitband-Anthelminthikum gegen Nematoden und

Leberegelbefall bei Rindern

ATCvet: QP52AE51

Zusammensetzung

1 ml Suspension enthält:

Wirkstoff: Triclabendazol 120 mg, Levamisolhydrochlorid 75 mg. Konservierungsmittel:

E 210, E 216, E 218. Antioxidantien: E 223. Excipiens ad suspensionem

Fachinformationen Wirkstoffe (CliniPharm)

Levamisol - Triclabendazol

Eigenschaften / Wirkungen

Levamisol wirkt gegen Nematoden und Triclabendazol gegen Leberegel. Der

Wirkmechanismus von Levamisol beruht auf der cholinergen Aktivität, die zu spastischen

Lähmungen der Nematoden führt. Ausserdem hemmt Levamisol die Fumarat-Reduktase.

Pharmakokinetik

Levamisol und Triclabendazol werden nach oraler Verabreichung rasch resorbiert. Das

resorbierte Triclabendazol wird sehr schnell zu Sulfoxiden und Sulfonen oxidiert. Maximale

Plasmakonzentrationen von Levamisol werden bereits nach 0,5 - 1 Stunde und für

Triclabendazol 24 - 36 Stunden nach der Verabreichung erreicht. Die Ausscheidung von

Levamisol erfolgt über den Urin und Kot und diejenige von Triclabendazol hauptsächlich

über den Kot.

Indikationen

Endex 19.5% eignet sich zur gleichzeitigen Behandlung reifer und sich entwickelnder

unreifer Stadien von Magenwürmern (Haemonchus, Ostertagia, T. axei), Darmwürmern

(Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum) und

Lungenwürmern (Dictyocaulus) sowie allen Formen der Infektion durch den grossen

Leberegel (frühe unreife, unreife und geschlechtsreife Stadien von Fasciola hepatica und

F. gigantica) bei Rindern.

Endex 19,5% wird oral mit Hilfe der üblichen Eingabegeräte oder einer Plastikspritze

verabreicht.

Empfohlene Dosis

12,0 mg Triclabendazol / kg Körpergewicht

7,5 mg Levamisolhydrochlorid / kg Körpergewicht

Praktische Dosierungsanleitung

1 ml/10 kg Körpergewicht.

Körpergewicht

Dosierung

50 kg

5,0 ml

100 kg

10,0 ml

150 kg

15,0 ml

200 kg

20,0 ml

250 kg

25,0 ml

300 kg

30,0 ml

für jeweils 50 kg mehr5,0 ml

Behandlungsprogramm

Endex 19.5% wird bei gleichzeitigem Befall mit Nematoden und grossem Leberegel

verabreicht.

Die Behandlung vor Beginn der Weidesaison beseitigt Würmer, die im Tier überwintert

haben und verhindert eine Verseuchung der Weide.

Die Behandlung während der Weidezeit eliminiert inzwischen erworbene Infektionen und

verringert die Kontamination der Weide mit Wurmeiern, die später zu Infektionen und

Erkrankungen führen würden.

Die Behandlung nach der Weideperiode wird empfohlen, um inzwischen neu erworbene

Infektionen zu eliminieren.

-Alle zugekauften Tiere sollten behandelt werden, bevor sie zur Herde stossen.

Anwendungseinschränkungen

Kontraindikationen

Das Produkt ist gegen geschlechtsreife Ostertagia-Stadien und sich entwickelnde Larven

wirksam. Es ist aber nicht zur Bekämpfung inhibierter Larven indiziert.

Vorsichtsmassnahmen

Keine.

Unerwünschte Wirkungen

VetVigilance: Pharmacovigilance-Meldung erstatten

Überdosierung kann zu vorübergehenden Nebenwirkungen führen (Muskelzittern,

Speichelfluss).

Essbare Gewebe: 28 Tage. Milch: 12 Tage, Behandlungen während der Trächtigkeit

sollten spätestens 7 Tage vor dem Abkalben erfolgen.

Wechselwirkungen

Keine bekannt.

Sonstige Hinweise

Nur für Tiere. Für Kinder unzugänglich aufbewahren. Nach Gebrauch Hände waschen.

Jegliche Verunreinigung mit dem Produkt oder dem leeren Behälter von stehenden und

fliessenden Gewässern sowie Wasserläufen vermeiden. Entleerte Behälter unschädlich

beseitigen. Bei Raumtemperatur (15 - 25°C) aufbewahren. Vor Feuchtigkeit, Frost und

Hitze schützen. Vor Gebrauch gut schütteln. Verabreichungsspritze vor und nach

Gebrauch gut reinigen.

Packungen

Flasche zu 800 ml.

Abgabekategorie: B

Swissmedic Nr. 51'377

Informationsstand: 03/2006

Dieser Text ist behördlich genehmigt.

12-1-2019

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FDA - U.S. Food and Drug Administration

4-1-2019

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds

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Shamrock Farms of Phoenix, Arizona is issuing a voluntary recall of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Best Before Date 3/16/2019. The recall comes after a product retain of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Use By 03/16/19 Time Stamp 08:18-11:13 04-05 #1, tested positive for an undeclared tree nut (almond) allergen.

FDA - U.S. Food and Drug Administration

3-1-2019

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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Das BfArM veröffentlicht den Umsetzungsbescheid für den Wirkstoff Levonorgestrel des Europäischen PSUR Single Assessment Verfahrens nach Artikel 107d) bis g) der Richtlinie 2001/83/EG.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

19-12-2018

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FDA - U.S. Food and Drug Administration

11-12-2018


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11-12-2018

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

11-12-2018

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

11-12-2018

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Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

22-11-2018


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Europe - EMA - European Medicines Agency

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

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Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Pest categorisation of non‐EU Monochamus spp.

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Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

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Europe - EFSA - European Food Safety Authority Publications

19-11-2018

November 19, 2018: Georgia Man Charged with Social Security and Wire Fraud

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FDA - U.S. Food and Drug Administration

20-10-2018

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

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

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Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

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

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

FDA - U.S. Food and Drug Administration

19-9-2018

Enforcement Report for the Week of September 19, 2018

Enforcement Report for the Week of September 19, 2018

Recently Updated Records for the Week of September 19, 2018 Last Modified Date: Tuesday, September 18, 2018

FDA - U.S. Food and Drug Administration

10-9-2018

FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series

FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series

On September 19, 2018, the FDA will host the third of a three-part eSubmitter webinar series. This session will provide a platform to answer any remaining questions participants may have after attending or viewing the first two webinars on the use of CVM’s electronic submission tool, eSubmitter.

FDA - U.S. Food and Drug Administration

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

Perlinring and associated names

Perlinring and associated names

Perlinring and associated names (Active substance: etonogestrel/ethinylestradiol) - Community Referrals - Art 29 - Commission Decision (2018)9141 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1473

Europe -DG Health and Food Safety

12-12-2018

TGA operations over the holiday period 2018-19

TGA operations over the holiday period 2018-19

The TGA will have limited operations from Monday 24 December 2018 until Wednesday 2 January 2018

Therapeutic Goods Administration - Australia

30-11-2018

Public submissions on scheduling matters referred to the ACMS #24 and Joint ACMS-ACCS #19 meetings held in June 2018

Public submissions on scheduling matters referred to the ACMS #24 and Joint ACMS-ACCS #19 meetings held in June 2018

Public submissions on the delegate's interim decision for alkyl nitrites

Therapeutic Goods Administration - Australia

26-11-2018

Levetiracetam Hospira (Pfizer Europe MA EEIG)

Levetiracetam Hospira (Pfizer Europe MA EEIG)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7985 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/T/19

Europe -DG Health and Food Safety

22-11-2018

Brintellix (H. Lundbeck A/S)

Brintellix (H. Lundbeck A/S)

Brintellix (Active substance: vortioxetine) - Centralised - Renewal - Commission Decision (2018)7896 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2717/R/19

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

2-10-2018

Uptravi (Janssen-Cilag International NV)

Uptravi (Janssen-Cilag International NV)

Uptravi (Active substance: selexipag) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6470 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3774/T/19

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

19-9-2018

Ilumetri (Almirall, S.A.)

Ilumetri (Almirall, S.A.)

Ilumetri (Active substance: tildrakizumab) - Centralised - Authorisation - Commission Decision (2018)6106 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4514

Europe -DG Health and Food Safety

19-9-2018

Hulio (Mylan S.A.S.)

Hulio (Mylan S.A.S.)

Hulio (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)6107 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004429/0000

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

19-9-2018

Fortacin (Recordati Ireland Ltd)

Fortacin (Recordati Ireland Ltd)

Fortacin (Active substance: lidocaine / prilocaine) - Centralised - Renewal - Commission Decision (2018)6103 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2693/R/23

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Stelara (Janssen-Cilag International NV)

Stelara (Janssen-Cilag International NV)

Stelara (Active substance: ustekinumab) - PSUSA - Modification - Commission Decision (2018)6102 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00003085/201712

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

CRYSVITA (Kyowa Kirin Holdings B.V.)

CRYSVITA (Kyowa Kirin Holdings B.V.)

CRYSVITA (Active substance: Burosumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6096 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4275/T/01

Europe -DG Health and Food Safety

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

28-8-2018

ACCM meeting statement, Meeting 19, 22 March 2018

ACCM meeting statement, Meeting 19, 22 March 2018

Advisory Committee on Complementary Medicines Meeting 19 meeting statement

Therapeutic Goods Administration - Australia