ISODUR TESTINA DI PROTESI 12/14 26MM L

Informazioni principali

  • Nome commerciale:
  • ISODUR TESTINA DI PROTESI 12/14 26MM L
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
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  • per i professionisti:
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Localizzazione

  • Disponibile in:
  • ISODUR TESTINA DI PROTESI 12/14 26MM L
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • TESTE FEMORALI IN MATERIALE METALLICO PER PROTESI TOTALI

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 28-09-2010
  • Ultimo aggiornamento:
  • 09-08-2016
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.

    Richiedi il foglio illustrativo per il pubblico.

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

16-1-2019

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

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

Software for Benchmark Dose Modelling

Software for Benchmark Dose Modelling

Published on: Mon, 14 Jan 2019 In specific contract No 7 issued under the framework agreement OC/EFSA/AMU/2015/02, EFSA requested Open Analytics to extend the Web application for Benchmark Dose Modelling built under specific contracts No 3 and No 4. The Web application is further developed in R with focus on creating a graphical module to evaluate model fit and to modify specific plot settings, as specified in the Technical Annex to Specific Contract No 7. The web application includes the latest develop...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Voorstelling van Zaken “GOED SCHEIDEN” in Internationaal Theater Amsterdam

Voorstelling van Zaken “GOED SCHEIDEN” in Internationaal Theater Amsterdam

De komende Voorstelling van Zaken GOED SCHEIDEN vindt plaats op dinsdag 26 februari 2019 van 14.00-17.15 uur in Internationaal Theater Amsterdam (voorheen Stadsschouwburg Amsterdam). De voorstelling is bedoeld voor professionals betrokken bij scheidingen. Phaedra Werkhoven, journalist en ervaringsdeskundige, leidt de gesprekken op het toneel. Acteurs Gijs Scholten van Aschat, Jacob Derwig en Hannah van Lunteren spelen scènes die de scheidingsproblematiek op unieke wijze zullen laten zien. Scheiden is pij...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Published on: Mon, 14 Jan 2019 Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify the original conclusions on their safety were identified. Th...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Published on: Mon, 14 Jan 2019 Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority 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 soybean A2704‐12, for food and feed uses, import and processing, excluding cultivation within th...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

15-1-2019

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

24-12-2018

Bonify recalls 14 lots of dried cannabis products

Bonify recalls 14 lots of dried cannabis products

The recalled products have record keeping issues with production documents that may not meet the requirements under theCannabis Regulations. As a result, Bonify has issued a recall as a precautionary measure.

Health Canada

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

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

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

On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results.

FDA - U.S. Food and Drug Administration

20-12-2018

Pest categorisation of Gymnosporangium spp. (non‐EU)

Pest categorisation of Gymnosporangium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Gymnosporangium spp. (non‐EU), a well‐defined and distinguishable group of fungal plant pathogens of the family Pucciniaceae affecting woody species. Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in th...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called He...

FDA - U.S. Food and Drug Administration

18-12-2018


eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

Europe - EMA - European Medicines Agency

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

18-12-2018

Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”

Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”

ATHERSTONE FOODS INC of Richmond, CA is recalling 14.6 ounce (414g) Greens and Grains Hummus and Quinoa Tabouleh Wrap, because it may contain undeclared soy, people who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

17-12-2018

Vijf jaar NIX brengt normverandering roken en drinken op gang

Vijf jaar NIX brengt normverandering roken en drinken op gang

Op 1 januari is het precies vijf jaar geleden dat de leeftijdsgrens voor roken en drinken werd verhoogd naar 18 jaar. In deze periode is er veel veranderd, blijkt uit een recente peiling in opdracht van het ministerie van VWS. Zo vindt ongeveer driekwart van de ouders en tieners het ‘normaal’ dat je pas mag roken en drinken vanaf 18 jaar. 78,2% van de ouders vindt dit tegenover 75,4% van de jongeren. De afgelopen jaren is het gebruik van alcohol onder tieners teruggelopen. Sinds 2011 gaat het in de total...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-12-2018

Teva Canada Product Recall (2018-12-17)

Teva Canada Product Recall (2018-12-17)

Health Canada

16-12-2018

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, 2018 tested positive for Listeria Monocytogenes. As a precautionary measure, we are recalling all products produced on the same day, same production line, as the ...

FDA - U.S. Food and Drug Administration

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018


Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Europe - EMA - European Medicines Agency

14-12-2018


European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

Europe - EMA - European Medicines Agency

18-1-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Europe - EMA - European Medicines Agency

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

Consultation: Good Clinical Practice Inspections Program

Consultation: Good Clinical Practice Inspections Program

The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019

Therapeutic Goods Administration - Australia

20-12-2018

TGA presentations: CAPSIG Seminar, 12 September 2018

TGA presentations: CAPSIG Seminar, 12 September 2018

Overview of regulatory requirements introduced as part of PIC/s PE009-13 Guide to GMP and a summary of the new PI041-1 Data Integrity

Therapeutic Goods Administration - Australia

19-12-2018

Consultation: Medical device cyber security

Consultation: Medical device cyber security

The TGA is seeking comments from interested parties on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. Closing date: 14 February 2019

Therapeutic Goods Administration - Australia

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

18-12-2018


Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

TGA is seeking comments on the expansion and amendment of TGO 54. Closing date: 12 February 2019

Therapeutic Goods Administration - Australia

17-12-2018


Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Adcetris,brentuximab vedotin,  13/12/2018,  Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trecondi,treosulfan,  13/12/2018,  Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2018)8912 of Fri, 14 Dec 2018

Europe -DG Health and Food Safety

14-12-2018

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8927 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2745/T/38

Europe -DG Health and Food Safety

14-12-2018

Valdoxan (Les Laboratoires Servier)

Valdoxan (Les Laboratoires Servier)

Valdoxan (Active substance: agomelatine) - Centralised - Renewal - Commission Decision (2018)8932 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/915/R/42

Europe -DG Health and Food Safety

14-12-2018

Ogivri (Mylan S.A.S.)

Ogivri (Mylan S.A.S.)

Ogivri (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)8913 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4916

Europe -DG Health and Food Safety

14-12-2018

LONGRANGE (Merial)

LONGRANGE (Merial)

LONGRANGE (Active substance: eprinomectin) - Refusal of authorisation - Commission Decision (2018)8905 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4291

Europe -DG Health and Food Safety

14-12-2018

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (Active substance: fluticasone furoate/vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8928 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2673/T/40

Europe -DG Health and Food Safety

14-12-2018

Dengvaxia (Sanofi Pasteur)

Dengvaxia (Sanofi Pasteur)

Dengvaxia (Active substance: dengue tetravalent vaccine (live, attenuated)) - Centralised - Authorisation - Commission Decision (2018)8933 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4171

Europe -DG Health and Food Safety

14-12-2018

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Active substance: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - Centralised - Authorisation - Commission Decision (2018)8911 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4814

Europe -DG Health and Food Safety

14-12-2018

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Renewal - Commission Decision (2018)8908 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/R/25

Europe -DG Health and Food Safety

14-12-2018


Summary of opinion: Besremi,ropeginterferon alfa-2b,  13/12/2018,  Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Lusutrombopag Shionogi,lusutrombopag,  13/12/2018,  Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rapiscan,regadenoson,  13/12/2018,  Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Miglustat Dipharma,miglustat,  13/12/2018,  Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Tobramycin PARI,tobramycin,  13/12/2018,  Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


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

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

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

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide,  13/12/2018,  Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Simponi,golimumab,  13/12/2018,  Positive

Summary of opinion: Simponi,golimumab, 13/12/2018, Positive

Summary of opinion: Simponi,golimumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Sprycel,dasatinib,  13/12/2018,  Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency