Equation Pro

Hauptinformation

  • Handelsname:
  • Equation Pro
  • Darreichungsform:
  • WG Wasserdispergierbares 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:
  • Equation Pro
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Fungizid

Weitere Informationen

Status

  • Quelle:
  • UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
  • Zulassungsnummer:
  • D-3931
  • Letzte Änderung:
  • 14-11-2018

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

Handelsbezeichnung: Equation Pro

(Parallelimport)

Pflanzenschutzmittelverzeichnis (Stand: 06.11.2018)

Produktkategorie:

Ausl. Bewilligungsinhaber:

Eidg. Zulassungsnummer:

Fungizid

DuPont de Nemours (Deutschland) GmbH D-3931

Stoff(e):

Gehalt:

Formulierungscode:

Wirkstoff: Cymoxanil

Wirkstoff: Famoxadone

30 % 22.5 %

WG Wasserdispergierbares Granulat

Anwendungen

A Kultur

Schaderreger/

Wirkung

Dosierungshinweise

Auflagen

W Reben

Falscher Mehltau der

Rebe

Konzentration: 0.04 %

Aufwandmenge: 0.64 kg/ha

Anwendung: Vom Stadium G (BBCH 53) bis

spätestens Mitte August.

1, 2, 3, 4, 5

Auflagen und Bemerkungen:

Maximal 3 Behandlungen pro Parzelle und Jahr.

SPe 3: Zum Schutz von Gewässerorganismen vor den Folgen von Drift eine unbehandelte

Pufferzone von 20 m zu Oberflächengewässern einhalten. Diese Distanz kann beim Einsatz von

driftreduzierenden Massnahmen gemäss den Weisungen des BLW reduziert werden.

Die angegebene Aufwandmenge bezieht sich auf Stadium BBCH 71-81 (J-M, Nachblüte) und eine

Referenzbrühemenge von 1600 l/ha (Berechnungsgrundlage) oder auf ein Laubwandvolumen von

4500 m³ pro ha.

Nachfolgearbeiten in behandelten Kulturen: bis 48 Stunden nach Ausbringung des Mittels

Schutzhandschuhe + Schutzanzug tragen.

Ansetzen der Spritzbrühe: Schutzhandschuhe tragen. Ausbringen der Spritzbrühe:

Schutzhandschuhe + Schutzanzug tragen. Technische Schutzvorrichtungen während des

Ausbringens (z.B. geschlossene Traktorkabine) können die vorgeschriebene persönliche

Schutzausrüstung ersetzen, wenn gewährleistet ist, dass sie einen vergleichbaren oder höheren

Schutz bieten.

Gefahrenkennzeichnungen:

Es gilt die Einstufung und Kennzeichnung der ausländischen Originaletikette..

Zusätzliche Schweizerische Gefahrenkennzeichnungen:

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

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.

22-1-2019

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-1-2019

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

ANSES has examined the ruling of 15 January 2019 by the French administrative court of Lyon overriding the marketing authorisation decision for Roundup Pro 360. It should be noted that, in order to protect human and environmental health, ANSES is responsible for implementing European regulations on the national level with regard to the marketing authorisation of regulated products (plant protection products, biocides and veterinary medicinal products). It also contributes to improving these regulations b...

France - Agence Nationale du Médicament Vétérinaire

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Products

Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Products

Ottogi America, Inc. announced today it is recalling below 21 items due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products.

FDA - U.S. Food and Drug Administration

18-1-2019

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

-- Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

FDA - U.S. Food and Drug Administration

18-1-2019

Updating of summaries of product characteristics due to changed ATC codes for 2019

Updating of summaries of product characteristics due to changed ATC codes for 2019

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2019.

Danish Medicines Agency

18-1-2019

Conair Consumer Products ULC recalls Cuisinart Vertical Waffle Iron

Conair Consumer Products ULC recalls Cuisinart Vertical Waffle Iron

A small number of the waffle irons may have been assembled improperly, which could cause the unit to malfunction and/or pose a risk of shock to consumers.

Health Canada

18-1-2019

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Published on: Thu, 17 Jan 2019 Open government data are about wide and free availability of public information created or collected by public entities. The International Open Data Charter and Findable, Accessible, Interoperable And Reusable Data (FAIR) data principles were selected as the guiding principles for the development of this report. A review of open data maturity reports indicated that most of the EU28+ are making significant progress in open government data, however there are different levels...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Auswirkungen des Brexit: Vorbereitungen des BfArM

Auswirkungen des Brexit: Vorbereitungen des BfArM

Nach dem sogenannten Brexit stehen die Arzneimittelagenturen des Vereinigten Königreichs für Human- und für Tierarzneimittel (Medicines and Healthcare Products Regulatory Agency, MHRA und Veterinary Medicines Directorate, VMD) voraussichtlich nicht mehr für Arzneimittelzulassungsverfahren innerhalb der Europäischen Union (EU) zur Verfügung. Betroffen vom Brexit sind insbesondere die Arzneimittelbewertung bei Herstellung, Entwicklung, Zulassung und Pharmakovigilanz . Die Experten des Bundesinstituts für A...

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen

RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen

RXBAR is voluntarily recalling certain varieties of bars because they may contain undeclared peanuts. People who have peanut allergies run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

15-1-2019

Specialized Bicycle Components Canada, Inc. recalls select Specialized-Branded Bicycles with Steerer Tube Collars

Specialized Bicycle Components Canada, Inc. recalls select Specialized-Branded Bicycles with Steerer Tube Collars

The steerer tube collar on the affected products may crack if exposed to corrosion which may cause the rider to loose control, posing fall and injury hazards. As of December 18, 2018, the company has not received any reports of incidents in Canada, and no report of injuries.

Health Canada

15-1-2019

EFSA's activities on emerging risks in 2017

EFSA's activities on emerging risks in 2017

Published on: Mon, 14 Jan 2019 The main objectives of EFSA's activities on emerging risks are: (i) to carry out activities to identify emerging risks in the areas within the remit of EFSA; and (ii) to develop and improve emerging risk identification methodologies and approaches. The current technical report summarises the activities of all groups involved in the emerging risk identification procedure, the issues identified in the course of 2017, a description of methodologies being developed and collabo...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2019


Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man

Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man

Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man

Europe - EMA - European Medicines Agency

14-1-2019


Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

Europe - EMA - European Medicines Agency

12-1-2019

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of Lactobacillus reuteri NBF‐2 (DSM 32264) as a feed additive for cats

Safety and efficacy of Lactobacillus reuteri NBF‐2 (DSM 32264) as a feed additive for cats

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the 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 Lactobacillus reuteri NBF‐2 when used in feed for cats at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32264. This species is considered by EFSA to be suitable for the qualified presum...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs

Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the 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 Lactobacillus reuteri NBF‐1 when used in feed for dogs at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32203. This species is considered by the European Food Safety Authority to be sui...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the 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 HOSTAZYM® X as a feed additive for rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys f...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-1-2019

Up Cannabis Inc. recalls one lot of Eldo dried cannabis

Up Cannabis Inc. recalls one lot of Eldo dried cannabis

The affected product may contain mould. In certain individuals, exposure to mould can result in allergic symptoms such as sneezing, coughing, wheezing, runny nose or nasal congestion, and watery eyes or itchy eyes.

Health Canada

10-1-2019

Public Notification: Slimina contains hidden drug ingredient

Public Notification: Slimina contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Slimina, a product promoted and sold for weight loss on various websites, including www.effectivehealthyproducts.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

10-1-2019

Public Notification: The Silver Bullet contains hidden drug ingredients

Public Notification: The Silver Bullet contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use The Silver Bullet, a product promoted for sexual enhancement and sold on various websites, including www.ebay.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

8-1-2019

Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil

Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil

Happy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall.

FDA - U.S. Food and Drug Administration

22-1-2019


Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201805

Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201805

Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201805

Europe - EMA - European Medicines Agency

22-1-2019


Acemetacin: List of nationally authorised medicinal products - PSUSA/00000026/201805

Acemetacin: List of nationally authorised medicinal products - PSUSA/00000026/201805

Acemetacin: List of nationally authorised medicinal products - PSUSA/00000026/201805

Europe - EMA - European Medicines Agency

22-1-2019


Fenspiride: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001368/201804

Fenspiride: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001368/201804

Fenspiride: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001368/201804

Europe - EMA - European Medicines Agency

22-1-2019


Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201804

Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201804

Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201804

Europe - EMA - European Medicines Agency

22-1-2019


Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805

Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805

Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805

Europe - EMA - European Medicines Agency

22-1-2019


Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Europe - EMA - European Medicines Agency

22-1-2019


EMA/2018/15/CO – Ex-ante publicity of a negotiated procedure - On demand supply of books

EMA/2018/15/CO – Ex-ante publicity of a negotiated procedure - On demand supply of books

EMA/2018/15/CO – Ex-ante publicity of a negotiated procedure - On demand supply of books

Europe - EMA - European Medicines Agency

21-1-2019


Nitrofurantoin, nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201802

Nitrofurantoin, nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201802

Nitrofurantoin, nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201802

Europe - EMA - European Medicines Agency

21-1-2019


Nitrofurantoin, nifurtoinol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002174/201802

Nitrofurantoin, nifurtoinol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002174/201802

Nitrofurantoin, nifurtoinol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002174/201802

Europe - EMA - European Medicines Agency

21-1-2019


Ciprofloxacin (systemic use):  List of nationally authorised medicinal products - PSUSA/00000775/201801

Ciprofloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00000775/201801

Ciprofloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00000775/201801

Europe - EMA - European Medicines Agency

21-1-2019


Ciprofloxacin (systemic use):  CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801

Ciprofloxacin (systemic use): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801

Ciprofloxacin (systemic use): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801

Europe - EMA - European Medicines Agency

18-1-2019


Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Europe - EMA - European Medicines Agency

18-1-2019


Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Europe - EMA - European Medicines Agency

18-1-2019


European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

Europe - EMA - European Medicines Agency

18-1-2019


Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Europe - EMA - European Medicines Agency

16-1-2019

Erleada (Janssen-Cilag International NV)

Erleada (Janssen-Cilag International NV)

Erleada (Active substance: apalutamide) - New authorisation - Commission Decision (2019)257 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4452

Europe -DG Health and Food Safety

16-1-2019

Product Quality Reviews (PQRs) for listed and complementary medicines

Product Quality Reviews (PQRs) for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

15-1-2019

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Active substance: macimorelin) - New authorisation - Commission Decision (2019)203 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4660

Europe -DG Health and Food Safety

14-1-2019

Paclitaxel Hetero and associated names

Paclitaxel Hetero and associated names

Paclitaxel Hetero and associated names (Active substance: paclitaxel) - Community Referrals - Art 29 - Commission Decision (2019)205 of Mon, 14 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H//A-29(4)/1466

Europe -DG Health and Food Safety

11-1-2019

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)) - New authorisation - Commission Decision (2019)135 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/V/C/4611

Europe -DG Health and Food Safety

11-1-2019

Isemid (Ceva SantE Animale)

Isemid (Ceva SantE Animale)

Isemid (Active substance: Torasemide) - New authorisation - Commission Decision (2019)134 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4345

Europe -DG Health and Food Safety

10-1-2019


BCG vaccine (freeze-dried): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation  - PSUSA/00000304/201803

BCG vaccine (freeze-dried): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000304/201803

BCG vaccine (freeze-dried): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000304/201803

Europe - EMA - European Medicines Agency

10-1-2019


BCG vaccine (freeze-dried): List of nationally authorised medicinal products - PSUSA/00000304/201803

BCG vaccine (freeze-dried): List of nationally authorised medicinal products - PSUSA/00000304/201803

BCG vaccine (freeze-dried): List of nationally authorised medicinal products - PSUSA/00000304/201803

Europe - EMA - European Medicines Agency

10-1-2019


Lorazepam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001909/201801

Lorazepam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001909/201801

Lorazepam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001909/201801

Europe - EMA - European Medicines Agency

10-1-2019


Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/201801

Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/201801

Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/201801

Europe - EMA - European Medicines Agency

9-1-2019


Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Europe - EMA - European Medicines Agency

9-1-2019

Silodosin Recordati (Recordati Ireland Ltd)

Silodosin Recordati (Recordati Ireland Ltd)

Silodosin Recordati (Active substance: silodosin) - New authorisation - Commission Decision (2019)73 of Wed, 09 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4964

Europe -DG Health and Food Safety

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Europe - EMA - European Medicines Agency

7-1-2019


Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products

Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products

Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products

Europe - EMA - European Medicines Agency

7-1-2019

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

The TGA is seeking your comments on the proposal to introduce new and amended definitions, and a revised scope of the products regulated as medical devices in Australia. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia