CTO-6GF

Informazioni principali

  • Nome commerciale:
  • CTO-6GF
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
  • 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.


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  • per i professionisti:
  • 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 i professionisti.

Localizzazione

  • Disponibile in:
  • CTO-6GF
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • GUIDE CORONARICHE INTERVENTISTICHE IDROFILE

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • N
  • Data dell'autorizzazione:
  • 30-03-2010
  • 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.

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

29-11-2018


Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

22-11-2018


Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Europe - EMA - European Medicines Agency

5-11-2018

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

FDA - U.S. Food and Drug Administration

31-10-2018

Enforcement Report for the Week of October 31, 2018

Enforcement Report for the Week of October 31, 2018

Recently Updated Records for the Week of October 31, 2018 Last Modified Date: Monday, October 29, 2018

FDA - U.S. Food and Drug Administration

30-10-2018

ANSES Newsletter in English - N°49 - October 2018

ANSES Newsletter in English - N°49 - October 2018

France - Agence Nationale du Médicament Vétérinaire

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Enforcement Report for the Week of October 24, 2018

Enforcement Report for the Week of October 24, 2018

Recently Updated Records for the Week of October 24, 2018 Last Modified Date: Monday, October 22, 2018

FDA - U.S. Food and Drug Administration

23-10-2018

October 22, 2018: Oklahoma Orthopedic Company to Pay $455,000 to Settle Claims of False Medical Billing

October 22, 2018: Oklahoma Orthopedic Company to Pay $455,000 to Settle Claims of False Medical Billing

October 22, 2018: Oklahoma Orthopedic Company to Pay $455,000 to Settle Claims of False Medical Billing

FDA - U.S. Food and Drug Administration

23-10-2018

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

October 23, 2018 For immediate release

Health Canada

22-10-2018

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

FDA - U.S. Food and Drug Administration

22-10-2018

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

FDA - U.S. Food and Drug Administration

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

18-10-2018

October 18, 2018: Pharmacist Indicted for Taking Drugs, Carrying Firearm in Violation of Court Order

October 18, 2018: Pharmacist Indicted for Taking Drugs, Carrying Firearm in Violation of Court Order

October 18, 2018: Pharmacist Indicted for Taking Drugs, Carrying Firearm in Violation of Court Order

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

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

FDA - U.S. Food and Drug Administration

16-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

16-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

15-10-2018

October 11, 2018: Two Companies Ordered to Pay More Than $7 Million for Adulterated and Misbranded Pet Food Ingredients

October 11, 2018: Two Companies Ordered to Pay More Than $7 Million for Adulterated and Misbranded Pet Food Ingredients

October 11, 2018: Two Companies Ordered to Pay More Than $7 Million for Adulterated and Misbranded Pet Food Ingredients

FDA - U.S. Food and Drug Administration

10-10-2018

October 4, 2018: Troutdale Doctor Sentenced for Purchasing and Administering Foreign-Sourced Botox and Juvaderm

October 4, 2018: Troutdale Doctor Sentenced for Purchasing and Administering Foreign-Sourced Botox and Juvaderm

October 4, 2018: Troutdale Doctor Sentenced for Purchasing and Administering Foreign-Sourced Botox and Juvaderm

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

FDA - U.S. Food and Drug Administration

3-10-2018

Enforcement Report for the Week of October 03, 2018

Enforcement Report for the Week of October 03, 2018

Recently Updated Records for the Week of October 03, 2018 Last Modified Date: Thursday, September 27, 2018

FDA - U.S. Food and Drug Administration

2-10-2018

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

FDA - U.S. Food and Drug Administration

1-10-2018

Enforcement Report for the Week of September 05, 2018

Enforcement Report for the Week of September 05, 2018

Recently Updated Records for the Week of September 05, 2018 Last Modified Date: Monday, October 01, 2018

FDA - U.S. Food and Drug Administration

28-9-2018

Debate on research dissemination at the Danish Medicines Agency

Debate on research dissemination at the Danish Medicines Agency

On 1 October, the Danish Medicines Agency and the Danish Society for Pharmacoepidemiology have invited a number of researchers, doctors and communication officers from research institutions throughout Denmark to a debate on how the findings of new health research can be disseminated most responsibly. The debate meeting can be followed live on the Danish Medicines Agency’s Facebook profile.

Danish Medicines Agency

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

7-8-2018

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

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

On August 22, 2018, FDA-CVM will host the second of a three-part webinar series on using eSubmitter, CVM’s electronic submission tool for the animal drug approval process. Sponsors must use eSubmitter to submit applications as of October 1, 2018.

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

20-6-2018

Signature of the framework agreement for the ESA Platform: strengthening epidemiological surveillance in animal health

Signature of the framework agreement for the ESA Platform: strengthening epidemiological surveillance in animal health

The signing of the new framework agreement for the Epidemiological Surveillance Platform for Animal Health (ESA Platform) on 20 June 2018 by the Director General for Food in the presence of Roger Genet, Director General of ANSES, and eight other members, signals a new departure for this platform, which has demonstrated its usefulness and effectiveness ever since it was set up in October 2011.  

France - Agence Nationale du Médicament Vétérinaire

19-6-2018

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Testing by the CSA Group has shown that glasses distributed between October 2017 and April 2018 do not comply with the side impact requirements of the safety standard for eye and face protectors. The affected safety glasses may not provide adequate protection against side impact, posing a risk of eye injury.

Health Canada

14-1-2019

Consultation: Benzocaine: proposed advisory statements for medicines

Consultation: Benzocaine: proposed advisory statements for medicines

The TGA is seeking comments on proposed new required label statements for medicines containing benzocaine. Closing date: 16 October 2018

Therapeutic Goods Administration - Australia

3-1-2019

Submissions received and high level summary: Transition to eCTD only for prescription medicines

Submissions received and high level summary: Transition to eCTD only for prescription medicines

The TGA would like to thank respondents who provided submissions in response to the October 2018 public consultation paper

Therapeutic Goods Administration - Australia

9-11-2018

ACM meeting statement, Meeting 11, 4 October 2018

ACM meeting statement, Meeting 11, 4 October 2018

The Advisory Committee on Medicines meeting statement for Meeting 11 is now available

Therapeutic Goods Administration - Australia

7-11-2018

ACMD meeting statement, Meeting 43, 11 October 2018

ACMD meeting statement, Meeting 43, 11 October 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

31-10-2018

Therapeutic goods advertising: Update 31 October 2018

Therapeutic goods advertising: Update 31 October 2018

The 2018 Code No.2 made today replaces the code that was made on 29 June 2018, and will take effect on 1 January 2019

Therapeutic Goods Administration - Australia

17-10-2018

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms:   http://go.usa.gov/xPkDE pic.twitter.com/IdHFDQ7dAW

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms: http://go.usa.gov/xPkDE pic.twitter.com/IdHFDQ7dAW

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms: http://go.usa.gov/xPkDE  pic.twitter.com/IdHFDQ7dAW

FDA - U.S. Food and Drug Administration

11-10-2018

October is #SIDSAwarenessMonth.  Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at  https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobacco pic.twitter.com/i37QX61Bb7

FDA - U.S. Food and Drug Administration

10-10-2018

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIH pic.twitter.com/AwYhetCBiw

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here:  https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

FDA - U.S. Food and Drug Administration

11-9-2018

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

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

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

Europe - EMA - European Medicines Agency

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

9-8-2018

Consultation: Proposed therapeutic goods advertising code guidance

Consultation: Proposed therapeutic goods advertising code guidance

The TGA is seeking input from interested parties on the revised version of the guidance to support the Code. Closing date: 4 October 2018

Therapeutic Goods Administration - Australia

6-8-2018

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Active substance: Moroctocog alfa ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5374 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/232/T/146

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

14-6-2018

ACSS public statement, 27-28 October 2017

ACSS public statement, 27-28 October 2017

ACSS Consortium Generic Medicines Working Group public statement for Brazil meeting, October 2017

Therapeutic Goods Administration - Australia

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety