CARDI-O-FIX PDA OCCLUDER

Informazioni principali

  • Nome commerciale:
  • CARDI-O-FIX PDA OCCLUDER
  • 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:
  • CARDI-O-FIX PDA OCCLUDER
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • PROTESI PER FORAMI OVALI PERVI E PER DOTTO DI BOTALLO

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 20-03-2010
  • 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.

22-1-2019

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

Published on: Mon, 21 Jan 2019 The European Commission is routinely asking EFSA for scientific and technical support in the epidemiological analysis of animal disease outbreaks (i.e. African swine fever, lumpy skin disease and avian influenza) and to report or assess surveillance data (i.e. Echinococcus multilocularis and avian influenza). For this purpose, EFSA has over the last years carried out several data collections and gathered specific information on outbreaks, surveillance activities and concer...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

17-1-2019

Updated Recall: HP Inc. Canada recalls Third-party Lithium-ion Batteries in Notebook Computers and Mobile Workstations

Updated Recall: HP Inc. Canada recalls Third-party Lithium-ion Batteries in Notebook Computers and Mobile Workstations

The battery can overheat, posing a potential burn and fire hazard.

Health Canada

17-1-2019

Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures

Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures

Published on: Wed, 16 Jan 2019 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the genotoxicity assessment of chemical mixtures. The draft statement was prepared by a dedicated working group of the Scientific Committee and endorsed by the Scientific Committee for public consultation at its 89th plenary meeting of 28‐29 May 2018. The public consultation for this document was open from 26 June until 9 ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Enforcement Report for the Week of January 16, 2019

Enforcement Report for the Week of January 16, 2019

Recently Updated Records for the Week of January 16, 2019 Last Modified Date: Tuesday, January 15, 2019

FDA - U.S. Food and Drug Administration

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

7-1-2019

Enforcement Report for the Week of January 02, 2019

Enforcement Report for the Week of January 02, 2019

Recently Updated Records for the Week of January 02, 2019 Last Modified Date: Monday, January 07, 2019

FDA - U.S. Food and Drug Administration

4-1-2019

Bee health

Bee health

For several years now, a phenomenon resulting in the weakening and mortality of bee colonies has been seen in many countries. In this context, the impact of various factors that may act alone or in combination on the health of bee colonies (infectious and parasitic diseases, stress related to changes in food resources, plant protection products, climate conditions, etc.) has regularly been demonstrated through different scientific studies. Below is an update on this issue and details of the Agency's work.

France - Agence Nationale du Médicament Vétérinaire

26-12-2018

Enforcement Report for the Week of December 26, 2018

Enforcement Report for the Week of December 26, 2018

Recently Updated Records for the Week of December 26, 2018 Last Modified Date: Friday, December 21, 2018

FDA - U.S. Food and Drug Administration

20-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.

FDA - U.S. Food and Drug Administration

19-12-2018

Enforcement Report for the Week of December 19, 2018

Enforcement Report for the Week of December 19, 2018

Recently Updated Records for the Week of December 19, 2018 Last Modified Date: Monday, December 17, 2018

FDA - U.S. Food and Drug Administration

19-12-2018

Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett™ 980 (Pb980) Ventilator Series

Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett™ 980 (Pb980) Ventilator Series

Medtronic (NYSE:MDT) is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett™ 980 (PB980) ventilator series. Medtronic initiated this field action on September 19, 2018.

FDA - U.S. Food and Drug Administration

18-12-2018

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

[07-26-2016] The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection).

FDA - U.S. Food and Drug Administration

18-12-2018

Medicines Safety Update, Volume 9, Number 4, December 2018

Medicines Safety Update, Volume 9, Number 4, December 2018

Infliximab and mycosis fungoides, infliximab and lupus-like syndrome, and medicine shortages mandatory reporting

Therapeutic Goods Administration - Australia

17-12-2018

Duodenoscope reprocessing

Duodenoscope reprocessing

Update - interim results from FDA surveillance studies

Therapeutic Goods Administration - Australia

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

13-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce <i>E. coli</i> O157:H7 outbreak investigation

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce <i>E. coli</i> O157:H7 outbreak investigation

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation

FDA - U.S. Food and Drug Administration

13-12-2018

Contaminants update: first of two opinions on PFAS in food

Contaminants update: first of two opinions on PFAS in food

Contaminants update: first of two opinions on PFAS in food

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

12-12-2018

Spilling the Beans: How Much Caffeine is Too Much?

Spilling the Beans: How Much Caffeine is Too Much?

In what foods is caffeine found? Can caffeine pose a danger to your health? This Consumer Update answers these and other key questions about caffeine.

FDA - U.S. Food and Drug Administration

12-12-2018

Enforcement Report for the Week of December 12, 2018

Enforcement Report for the Week of December 12, 2018

Recently Updated Records for the Week of December 12, 2018 Last Modified Date: Wednesday, December 12, 2018

FDA - U.S. Food and Drug Administration

11-12-2018

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

FDA - U.S. Food and Drug Administration

10-12-2018

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.

FDA - U.S. Food and Drug Administration

9-12-2018

TachoSil

TachoSil

Product approval information is indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

FDA - U.S. Food and Drug Administration

5-12-2018

Enforcement Report for the Week of December 05, 2018

Enforcement Report for the Week of December 05, 2018

Recently Updated Records for the Week of December 05, 2018 Last Modified Date: Friday, November 30, 2018

FDA - U.S. Food and Drug Administration

30-11-2018

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Published on: Thu, 29 Nov 2018 This update on the African swine fever (ASF) outbreaks in the EU demonstrated that out of all tested wild boar found dead, the proportion of positive samples peaked in winter and summer. For domestic pigs only, a summer peak was evident. Despite the existence of several plausible factors that could result in the observed seasonality, there is no evidence to prove causality. Wild boar density was the most influential risk factor for the occurrence of ASF in wild boar. In th...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

Updates on the presence of TSEs in the EU

Updates on the presence of TSEs in the EU

Updates on the presence of TSEs in the EU

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

28-11-2018

Enforcement Report for the Week of November 28, 2018

Enforcement Report for the Week of November 28, 2018

Recently Updated Records for the Week of November 28, 2018 Last Modified Date: Tuesday, November 27, 2018

FDA - U.S. Food and Drug Administration

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

17-1-2019

Supplier assessment, approval and qualification for listed and complementary medicines

Supplier assessment, approval and qualification for listed and complementary medicines

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

Therapeutic Goods Administration - Australia

16-1-2019

Sampling and testing for listed and complementary medicines

Sampling and testing for listed and complementary medicines

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

Therapeutic Goods Administration - Australia

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

16-1-2019

Process validation for listed and complementary medicines

Process validation 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

Ongoing stability testing for listed and complementary medicines

Ongoing stability testing 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

Medicinal gases guidance

Medicinal gases guidance

Medicinal gases guidance has been updated to reflect expectations of the new PIC/S guide to GMP PE009-13

Therapeutic Goods Administration - Australia

14-1-2019


Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Europe - EMA - European Medicines Agency

4-1-2019

GMP clearance guidance update - Version 18.1

GMP clearance guidance update - Version 18.1

Updated version of GMP clearance guidance (Version 18.1)

Therapeutic Goods Administration - Australia

4-1-2019

GMP clearance guidance

GMP clearance guidance

Updated version of GMP clearance guidance (Version 18.1)

Therapeutic Goods Administration - Australia

3-1-2019

Reformatting Product Information: Frequently asked questions

Reformatting Product Information: Frequently asked questions

Updated to include new and revised FAQs

Therapeutic Goods Administration - Australia

20-12-2018

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here:  https://go.usa.gov/

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/

. @US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB  #MedicalDevice

FDA - U.S. Food and Drug Administration

18-12-2018

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers:  https://go.usa.gov/xEx2r  #FDApic.twitter.com/57pZAmSb9r

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDApic.twitter.com/57pZAmSb9r

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDA pic.twitter.com/57pZAmSb9r

FDA - U.S. Food and Drug Administration

14-12-2018

#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological  Health, released a statement on updated safety  communication about  rates of duodenoscope contamination from  preliminary postmarket data.  Read the statement here:  https://go.usa.g

#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.g

#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.gov/xE3kf  #MedicalDevice

FDA - U.S. Food and Drug Administration

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

12-12-2018

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Active substance: daclatasvir) - Centralised - Yearly update - Commission Decision (2018)8758 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Active substance: atazanavir / cobicistat) - Centralised - Yearly update - Commission Decision (2018)8679 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

11-12-2018

Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Tenofovir disoproxil Zentiva (Active substance: tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)8683 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

11-12-2018

Xermelo (Ipsen Pharma)

Xermelo (Ipsen Pharma)

Xermelo (Active substance: telotristat) - Centralised - Yearly update - Commission Decision (2018)8684 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

11-12-2018

Aivlosin (ECO Animal Health Ltd)

Aivlosin (ECO Animal Health Ltd)

Aivlosin (Active substance: Tylvalosin) - Centralised - Yearly update - Commission Decision (2018)8687 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

11-12-2018

Regulation of Software as a Medical Device

Regulation of Software as a Medical Device

Updated information on the regulation of Software as a Medical Device

Therapeutic Goods Administration - Australia

5-12-2018

Updates to the Database of TGA laboratory testing results

Updates to the Database of TGA laboratory testing results

New release of results published

Therapeutic Goods Administration - Australia

4-12-2018


Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Europe - EMA - European Medicines Agency

30-11-2018

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2018)8149 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8159 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Keppra (UCB Pharma S.A.)

Keppra (UCB Pharma S.A.)

Keppra (Active substance: levetiracetam) - Centralised - Yearly update - Commission Decision (2018)8160 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8158 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

28-11-2018

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8044 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/242/T/73

Europe -DG Health and Food Safety

28-11-2018

Leflunomide ratiopharm (ratiopharm GmbH)

Leflunomide ratiopharm (ratiopharm GmbH)

Leflunomide ratiopharm (Active substance: leflunomide) - Centralised - Yearly update - Commission Decision (2018)8045 of Wed, 28 Nov 2018

Europe -DG Health and Food Safety

28-11-2018

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Active substance: darunavir) - Centralised - 2-Monthly update - Commission Decision (2018)8046 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4891/IB/2/G

Europe -DG Health and Food Safety

28-11-2018

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Yearly update - Commission Decision (2018)8049 of Wed, 28 Nov 2018

Europe -DG Health and Food Safety

27-11-2018

Soliris (Alexion Europe SAS)

Soliris (Alexion Europe SAS)

Soliris (Active substance: Eculizumab) - Centralised - Yearly update - Commission Decision (2018)7968 of Tue, 27 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Active substance: efavirenz / emtricitabine / tenofovir disoproxil fumarate) - Centralised - 2-Monthly update - Commission Decision (2018)7982 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/797/II/130

Europe -DG Health and Food Safety

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Kyprolis (Amgen Europe B.V.)

Kyprolis (Amgen Europe B.V.)

Kyprolis (Active substance: carfilzomib) - Centralised - Yearly update - Commission Decision (2018)7965 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety