FALCO 202 EVO

Informazioni principali

  • Nome commerciale:
  • FALCO 202 EVO
  • 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:
  • FALCO 202 EVO
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • VENTILATORI POLMONARI PER USO EXTRAOSPEDALIERO

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • N
  • 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.

17-1-2019

Outcome of the Public Consultation on the draft Guidance on Communication of Uncertainty in Scientific Assessments

Outcome of the Public Consultation on the draft Guidance on Communication of Uncertainty in Scientific Assessments

Published on: Wed, 16 Jan 2019 The first strategic objective of EFSA's strategy 2020 ‘Trusted science for safe food’ is the prioritisation of public and stakeholder engagement in the development of scientific assessment. To achieve this, objective public consultations are a key step for such a strategic framework. The draft Guidance document on communication of uncertainty underwent a web‐based public consultation from 4 May to 24 June 2018. The document provides guidance for communicators on how to com...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-12-2018

 Occupational health: aiming to take better account of multiple exposure

Occupational health: aiming to take better account of multiple exposure

Workers can potentially be exposed to numerous health risk factors through their occupations. The question of multiple exposure is a major challenge for all those active in the field of occupational health, safety and prevention. As part of the 2016-2020 National Occupational Health Plan, a review of the measures taken by the main players to address the question of multiple exposure in France and abroad is being published today. This work has helped determine the state of knowledge and the issues surroun...

France - Agence Nationale du Médicament Vétérinaire

3-12-2018


Agenda - Regulatory science to 2025: launch of veterinary stakeholder consultation

Agenda - Regulatory science to 2025: launch of veterinary stakeholder consultation

Agenda - Regulatory science to 2025: launch of veterinary stakeholder consultation

Europe - EMA - European Medicines Agency

29-11-2018


Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025, European Medicines Agency, London, UK, from 06/12/2018 to 06/12/2018

Europe - EMA - European Medicines Agency

24-11-2018

Blokhuis: 1,25 miljoen euro voor educatie Tweede Wereldoorlog

Blokhuis: 1,25 miljoen euro voor educatie Tweede Wereldoorlog

Staatssecretaris Paul Blokhuis van Volksgezondheid, Welzijn en Sport heeft 1,25 miljoen euro beschikbaar gesteld voor educatieprojecten over de Tweede Wereldoorlog. In 2019 en 2020 vieren we dat Nederland 75 jaar is bevrijd, eerst het zuidelijke deel in 1944 en daarna de rest van Nederland en Nederlands-Indië in 1945. Dit lustrumjaar wordt de bevrijding nog groter gevierd dan anders en wordt er extra nadruk gelegd op het herinneren van de oorlog. De 1,25 miljoen euro komt boven op de 3,5 miljoen voor ond...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-11-2018

Publiekscampagne Ik Zorg van start

Publiekscampagne Ik Zorg van start

Vandaag gaven minister Hugo de Jonge, minister Bruno Bruins en staatssecretaris Paul Blokhuis het startsein voor de publiekscampagne Ik Zorg. Hiermee willen de sector Zorg en Welzijn en de overheid nieuwe werknemers aantrekken. Dat is hard nodig, om ook in de toekomst iedereen goede zorg te kunnen blijven bieden. Als we nu niks doen, hebben we in 2022 een tekort van 125.000 mensen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-11-2018

Three research projects to increase our knowledge of medicinal cannabis

Three research projects to increase our knowledge of medicinal cannabis

Three projects have just been granted funds to give us more knowledge about the efficacy of medicinal cannabis. A total of DKK 5 million have been distributed of the funds that were appropriated by the negotiating parliamentary parties under the special funds agreement 2018-2021 to accumulate scientific knowledge of medicinal cannabis.

Danish Medicines Agency

6-10-2018

Nederland organiseert volgende wereldwijde WHO conferentie tegen tabak

Nederland organiseert volgende wereldwijde WHO conferentie tegen tabak

In 2020 organiseert Nederland de volgende wereldwijde conferentie van de Wereldgezondheidsorganisatie tegen tabak. Het gaat om de negende editie van de zogenaamde Conference of the Parties (COP) van het WHO FCTC verdrag. Dat is vandaag bekendgemaakt in Genève tijdens de sluitingsceremonie van de achtste COP. Staatssecretaris Paul Blokhuis (VWS) heeft het initiatief genomen om de conferentie naar Nederland te halen en was op 1 oktober in Genève om de Nederlandse kandidatuur kracht bij te zetten.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch, because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

31-8-2018

La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos

La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos

La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos

FDA - U.S. Food and Drug Administration

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

On 8/14/18, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 was signed into law to reauthorize ADUFA and AGDUFA. These programs help FDA maintain a predictable and timely animal drug review process, foster innovation, and expedite access to new therapies for animals.

FDA - U.S. Food and Drug Administration

16-8-2018

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weak...

FDA - U.S. Food and Drug Administration

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

11-7-2018

Yakima Products Inc. recalls Yakima HoldUp EVO Bicycle Carriers

Yakima Products Inc. recalls Yakima HoldUp EVO Bicycle Carriers

The snap pins can become loose and fall out causing the rear wheel cup (and rear wheel) to detach from the main frame. Prior warnings of this defect may include sliding or banging noises when the rear wheel and wheel cup hits the ground. This can result in a bicycle ejection, causing a crash or personal injury to persons outside the vehicle.

Health Canada

6-7-2018

Bekrachtiging besluit tot zelfstandige bevoegdheden voor mondhygiënisten

Bekrachtiging besluit tot zelfstandige bevoegdheden voor mondhygiënisten

De ministerraad heeft ingestemd met het besluit van minister Bruins voor Medische zorg om mondhygiënisten vanaf 1 januari 2020 zelfstandige bevoegdheden te geven. Het gaat om een  experiment voor een periode van vijf jaar. Ze mogen zelfstandig verdoven, röntgenfoto’s maken en eerste gaatjes vullen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

6-7-2018

Revocation of S-classification status for certain
medicinal products: lists

Revocation of S-classification status for certain medicinal products: lists

The Icelandic Medicines Agency (IMA) has decided to revoke the S-classified status of medicinal products that have also been used outside the hospital  environment as well as for products which are now not considered to be limited to hospital use.

IMA - Icelandic Medicines Agency

5-7-2018

Blokhuis: jaarlijks 4 miljoen euro naar onderzoek Lifelines tot 2024

Blokhuis: jaarlijks 4 miljoen euro naar onderzoek Lifelines tot 2024

Derde onderzoeksronde Lifelines in 2019 van start Lifelines, de data- en biobank waarin informatie over de gezondheid van drie generaties inwoners in de noordelijke provincies gedurende dertig jaar wordt verzameld, start in 2019 met de derde onderzoeksronde onder alle Lifelines-deelnemers. Dit wordt mogelijk gemaakt door het Ministerie van VWS, de RUG en het UMCG en de provincies Groningen, Friesland en Drenthe. Deze gezamenlijke inzet weerspiegelt het belang van Lifelines voor zowel volksgezondheid, wet...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

2-7-2018

€ 70 miljoen voor uitkomstgerichte zorg

€ 70 miljoen voor uitkomstgerichte zorg

Minister Bruno Bruins voor Medische Zorg en Sport investeert € 70 miljoen in uitkomstgerichte zorg (2018-2022). Uitgangspunt is dat een goede behandeling moet passen bij de persoonlijke situatie van de patiënt. En dat kan voor iedereen anders zijn. Arts en patiënt moeten samen kunnen beslissen wat voor die persoon de beste behandeling is en waar de kwaliteit het beste is. Om die ontwikkeling te stimuleren worden de komende jaren stappen gezet.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-6-2018

Bruins bereikt onderhandelaarsakkoord huisartsen 2019-2022

Bruins bereikt onderhandelaarsakkoord huisartsen 2019-2022

Minister Bruno Bruins voor Medische Zorg en Sport heeft een onderhandelaarsakkoord bereikt met partijen uit de huisartszorg. De komende jaren wordt  € 471 miljoen beschikbaar gesteld voor het versterken van de huisartsenzorg. Dit budget is onder andere beschikbaar om meer tijd te hebben voor en met de patiënt, de zorg in de avond-, nacht- en weekenduren, het versterken van de organisatiegraad van de eerste lijn, de zorg voor kwetsbare groepen en  ICT-infrastructuur. Huisartsen(organisaties) en verzekeraa...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-6-2018

Ministers: voedselveiligheid verder versterken urgent

Ministers: voedselveiligheid verder versterken urgent

De Commissie Sorgdrager heeft een grondige analyse gemaakt van de wijze waarop de fipronilcrisis is afgehandeld en spreekt alle relevante actoren –het bedrijfsleven, de toezichthouders en departementen– aan op hun functioneren. Het beeld dat het rapport schetst is niet fraai. De pluimveehouders die nog steeds met de gevolgen van de crisis kampen, voelen het als geen ander.  De aanbevelingen om de voedselveiligheid verder te versterken worden opgevolgd. Dat schrijven de ministers Bruno Bruins en Carola Sc...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

22-6-2018

Cliënten geestelijke gezondheidszorg vanaf 2021 toegang tot Wet langdurige zorg

Cliënten geestelijke gezondheidszorg vanaf 2021 toegang tot Wet langdurige zorg

Mensen die hun leven lang intensieve geestelijke gezondheidszorg (GGZ) nodig hebben, kunnen vanaf 2021 toegang krijgen tot de Wet langdurige zorg (Wlz). Staatssecretaris Blokhuis van Volksgezondheid, Welzijn en Sport heeft de Tweede Kamer vandaag geïnformeerd dat dit wetsvoorstel deze zomer in consultatie zal zijn. Dat betekent dat alle betrokkenen - zoals instellingen, professionals, cliënten en hun naasten - in en om de geestelijke gezondheidszorg hun mening erover kunnen geven.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Pevonedistat, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Pevonedistat, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

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

6-6-2018

Hoofdlijnenakkoord wijkverpleging ondertekend

Hoofdlijnenakkoord wijkverpleging ondertekend

Minister Hugo de Jonge van VWS en de partijen in de wijkverpleging hebben vandaag het hoofdlijnenakkoord wijkverpleging ondertekend. Daarmee worden de door de onderhandelaars gemaakte eerdere afspraken definitief van kracht. Het akkoord betekent onder meer dat er € 435 miljoen extra beschikbaar gesteld wordt voor de wijkverpleging voor de periode 2019-2022.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

26-5-2018

Giant/Martin’s Voluntarily Recalls Private Brand Frozen Broccoli Cuts

Giant/Martin’s Voluntarily Recalls Private Brand Frozen Broccoli Cuts

GIANT Food Stores, LLC is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution following a supplier notification that the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

26-5-2018

Stop & Shop Voluntarily Recalls Stop & Shop Frozen Broccoli Cuts

Stop & Shop Voluntarily Recalls Stop & Shop Frozen Broccoli Cuts

Stop & Shop is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution due to our supplier notifying us the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

25-5-2018

Giant Food Voluntarily Recalls Giant Food Frozen Broccoli Cuts

Giant Food Voluntarily Recalls Giant Food Frozen Broccoli Cuts

Giant Food, LLC is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution due to our supplier notifying us the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

24-5-2018

Deere & Company recalls John Deere Front Loader

Deere & Company recalls John Deere Front Loader

The ballasting information for the loader when attached to a John Deere model 2025R tractor is missing from the operator’s manual. If improperly ballasted, the tractor may be unstable and cause injury to the operator or bystanders.

Health Canada

23-6-2017

Substantial progress in cooperation with CFDA only six weeks after state visit

Substantial progress in cooperation with CFDA only six weeks after state visit

During the official state visit at the beginning of May, the Chinese and Danish Ministers for Health and Food signed a Memorandum of Understanding about the establishment of the China-Denmark Food and Drug Regulatory Cooperation Centre. Only six weeks after the state visit, the China Food and Drug Administration (CFDA) and the Danish Medicines Agency held a successful seminar on 20 and 21 June in Beijing on the licensing of medicines and the drafting of a work programme with common activities up to and i...

Danish Medicines Agency

8-8-2016

Efficacy of emergency contraception may be reduced when taken with other medicines

Efficacy of emergency contraception may be reduced when taken with other medicines

Women seeking the Norlevo or Levodonna emergency contraceptives should be aware that the efficacy may be reduced when taken with other medicines.

Danish Medicines Agency

15-1-2014

Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products with the authorisation IDs 25081 and 25082 granted to Singad Pharma ApS (company number 255894).

Danish Medicines Agency

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

19-12-2018


Regulatory Science to 2025 – launch of six-month public consultation

Regulatory Science to 2025 – launch of six-month public consultation

Regulatory Science to 2025 – launch of six-month public consultation

Europe - EMA - European Medicines Agency

28-11-2018

GILENYA (Novartis Europharm Limited)

GILENYA (Novartis Europharm Limited)

GILENYA (Active substance: Fingolimod) - Centralised - Variation - Commission Decision (2018)7969 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2202/X/44

Europe -DG Health and Food Safety

20-11-2018

Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration

Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration

Philips has agreed to notify any actual or anticipated shortages of accessories, repair parts and consumables of the HeartStart MRx in Australia until 31 December 2022

Therapeutic Goods Administration - Australia

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

29-8-2018

BYDUREON (AstraZeneca AB)

BYDUREON (AstraZeneca AB)

BYDUREON (Active substance: exenatide) - Centralised - Variation - Commission Decision (2018)5776 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2020/X/48/G

Europe -DG Health and Food Safety

1-8-2018

Viagra (Pfizer Europe MA EEIG)

Viagra (Pfizer Europe MA EEIG)

Viagra (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5203 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/202/T/98

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2029 (Klinikum der UniversitAt MUnchen)

EU/3/18/2029 (Klinikum der UniversitAt MUnchen)

EU/3/18/2029 (Active substance: 2-[(2S)-2-methyl-1,4-dioxa-8-azaspiro[4.5]dec-8-yl]-8-nitro-6-trifluoromethyl-4H-1,3-benzothiazin-4-one) - Orphan designation - Commission Decision (2018)4174 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/004/18

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

4-6-2018

Accordi transattivi 2013-2015 - Determina AIFA n° 854/2018

Accordi transattivi 2013-2015 - Determina AIFA n° 854/2018

Si comunica che in data 30 maggio 2018 è stata adottata la Determina n. 854/2018 avente per oggetto “Riepilogo degli importi a carico di ciascuna azienda farmaceutica titolare di AIC per ciascuno degli anni 2013, 2014 e 2015", ai sensi dell’articolo 1, comma 391, della legge 27 dicembre 2017, n. 205, recante “Bilancio di previsione dello Stato per l’anno finanziario 2018 e bilancio pluriennale per il triennio 2018-2020”.Continua

Italia - AIFA - Agenzia Italiana del Farmaco

29-5-2018

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Active substance: Three human monoclonal antibodies against the Ebola virus glycoprotein) - Orphan designation - Commission Decision (2018)3395 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/18

Europe -DG Health and Food Safety

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

29-5-2018

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Active substance: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles) - Orphan designation - Commission Decision (2018)3393 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/017/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2024 (Galephar M/F)

EU/3/18/2024 (Galephar M/F)

EU/3/18/2024 (Active substance: Itraconazole) - Orphan designation - Commission Decision (2018)3392 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/251/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2023 (Dr Regenold GmbH)

EU/3/18/2023 (Dr Regenold GmbH)

EU/3/18/2023 (Active substance: H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O2)-NH2-DOTA-225-actinium) - Orphan designation - Commission Decision (2018)3391 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/252/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2022 (Hanmi Europe Limited)

EU/3/18/2022 (Hanmi Europe Limited)

EU/3/18/2022 (Active substance: Glucagon analogue linked to a human immunoglobulin Fc fragment) - Orphan designation - Commission Decision (2018)3389 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/257/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2021 (Chemo Research S.L.)

EU/3/18/2021 (Chemo Research S.L.)

EU/3/18/2021 (Active substance: Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin) - Orphan designation - Commission Decision (2018)3388 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2020 (Janssen-Cilag International NV)

EU/3/18/2020 (Janssen-Cilag International NV)

EU/3/18/2020 (Active substance: Daratumumab) - Orphan designation - Commission Decision (2018)3387 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/207/17

Europe -DG Health and Food Safety

25-5-2018

Medical devices and IVDs: Suspensions from the ARTG

Medical devices and IVDs: Suspensions from the ARTG

Revocation of suspension of Device Embolisation Device ARTG entries 281030 and 281033

Therapeutic Goods Administration - Australia

22-3-2018

Comunicazione EMA sul ritiro dal commercio dell’antidolorifico flupirtina (23/03/2018)

Comunicazione EMA sul ritiro dal commercio dell’antidolorifico flupirtina (23/03/2018)

Il Gruppo di Coordinamento per le Procedure di Mutuo Riconoscimento e Decentrate (CMDh) ha approvato la raccomandazione dell'EMA di revocare l'autorizzazione all'immissione in commercio per il medicinale antidolorifico flupirtina, a causa del rischio di gravi danni epatici.

Italia - AIFA - Agenzia Italiana del Farmaco