Accessibility Statement Skip Navigation
  • Resources
  • Investor Relations
  • Journalists
  • Agencies
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • All Public Company
      • English-only
      • News Releases Overview

      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
      • Multimedia Gallery Overview

      • Trending Topics

      • All Trending Topics
  • Business & Money
      • Auto & Transportation

      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • Auto & Transportation Overview

      • View All Auto & Transportation

      • Business Technology

      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • Business Technology Overview

      • View All Business Technology

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Financial Services & Investing

      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • Financial Services & Investing Overview

      • View All Financial Services & Investing

      • General Business

      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • General Business Overview

      • View All General Business

  • Science & Tech
      • Consumer Technology

      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • Consumer Technology Overview

      • View All Consumer Technology

      • Energy & Natural Resources

      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • Energy & Natural Resources Overview

      • View All Energy & Natural Resources

      • Environ­ment

      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • Environ­ment Overview

      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • Heavy Industry & Manufacturing Overview

      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • Telecomm­unications Overview

      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • Consumer Products & Retail Overview

      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Health

      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • Health Overview

      • View All Health

      • Sports

      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • Sports Overview

      • View All Sports

      • Travel

      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • Travel Overview

      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • Policy & Public Interest Overview

      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • People & Culture Overview

      • View All People & Culture

      • In-Language News

      • Arabic
      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Explore Our Platform
  • Plan Campaigns
  • Create with AI
  • Distribute Press Releases
  • Amplify Content
  • All Products
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Hamburger menu
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO
    • Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • Explore Our Platform
  • Plan Campaigns
  • Create with AI
  • Distribute Press Releases
  • Amplify Content
  • All Products
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS

Taffix® obtém novamente aprovação para ser comercializado na Espanha
  • USA - English
  • Israel - English
  • Latin America - español
  • France - Français
  • Italia - Italiano
  • España - español
  • Deutschland - Deutsch

Nasus Pharma anuncia que a AEMPS espanhola suspendeu a restrição de comercialização do Taffix® na Espanha, aceitando a posição do órgão autorizado pela UE na classificação, segurança e comprovação clínica do Taffix

Nasus Pharma Logo

News provided by

Nasus Pharma

Aug 17, 2021, 07:00 ET

Share this article

Share toX

Share this article

Share toX

TEL AVIV, Israel, 17 de agosto de 2021 /PRNewswire/ -- A Nasus Pharma, empresa biofarmacêutica privada de estágio clínico que desenvolve uma solução terapêutica intranasal em pó (PBI), anunciou hoje  que a Agência Espanhola de Medicamentos e Dispositivos Médicos (AEMPS) permitiu, em 13 de agosto, que o Taffix seja comercializado na Espanha, suspendendo sua restrição de comercialização emitida em 12 de março.

Em 12 de março de 2021, a AEMPS publicou o alerta 2021-140, em que foi relatado que o distribuidor do TAFFIX na Espanha tinha sido incitado a interromper a comercialização e a retirar o produto do mercado espanhol, já que a AEMPS tinha preocupações quanto à classificação do Taffix como dispositivo médico de classe 1 e quanto à comprovação das alegações clínicas.

Após uma investigação e reavaliação da documentação e dos dados do dispositivo, a AEMPS aceitou a posição do Staatliches Gewerbeaufsichtsamt  em Hannover, o órgão autorizado na UE, de que a classificação do Taffix como dispositivo médico de classe 1 é justificada e de que o Taffix pode ser comercializado na Espanha como tal sob a Diretiva 93/42/EC. A AEMPS também validou que os dados clínicos do Taffix comprovam seu uso como barreira mecânica de proteção contra vírus dentro da cavidade nasal.

A Dra. Dalia Megiddo, CEO da Nasus Pharma, comentou: "Estamos felizes que a AEMPS tenha aceito a posição do órgão responsável da UE em relação à classificação e validade de nossos dados. O Taffix é um dispositivo médico de proteção viral seguro e eficaz, e esperamos que esteja novamente disponível para o povo espanhol, já que está disponível para muitas pessoas em todo o mundo."

Udi Gilboa, presidente ativo da diretoria da Nasus Pharma, acrescentou: "Gostaríamos de agradecer à AEMPS por seu processo de análise colaborativa e diligente e por sua atitude profissional e atenção dedicada durante toda a análise investigativa que realizou. Esperamos trazer o Taffix de volta ao mercado espanhol, para colaborar com comunidades espanholas e trabalhar em estreita colaboração com as partes interessadas da saúde para o benefício do povo e dos consumidores espanhóis." 

O Taffix®, atualmente presente em mais de 25 países em toda a Europa, América Latina, Ásia e Oriente Médio, foi desenvolvido para criar um microambiente ácido no nariz, que comprovadamente impede que vírus entrem e infectem as células nasais. Agora está bem estabelecido que o nariz é a principal porta de entrada do corpo para infecções virais transmitidas pelo ar. O Taffix® em pó cria um gel fino acidificado único acima da mucosa nasal que dura 5 horas, protegendo significativamente as células nasais de vírus inalados por meio de proteção mecânica e química. Como tal, o Taffix® pode ser uma ferramenta adicional de proteção importante, além das diversas medidas preventivas tomadas atualmente para prevenir a propagação de infecções virais.

Sobre a Nasus Pharma: 

Com base em sua tecnologia única de microesferas, a Nasus Pharma está desenvolvendo uma série de produtos intranasais em pó com o objetivo de auxiliar pacientes em várias situações de emergência agudas, como overdose opioide e choque anafilático.

A administração intranasal é mais adequada para situações em que é necessária a aplicação rápida do medicamento e oferece várias vantagens, como aplicação rápida de medicamentos, facilidade de uso, caráter não invasivo e segurança. O portfólio da Nasus compreende uma série de programas: Intranasal Naloxone (estudo central concluído) e epinefrina Intranasal (Fase 2 concluída), bem como vários programas pré-clínicos em pontos de atendimento.

Logotipo - https://mma.prnewswire.com/media/1485582/Nasus_Pharma_Logo.jpg

www.Taffixprotect.com 

Contato: [email protected] 

FONTE Nasus Pharma

WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?

icon3
440k+
Newsrooms &
Influencers
icon1
9k+
Digital Media
Outlets
icon2
270k+
Journalists
Opted In
GET STARTED

Modal title

Also from this source

Nasus Pharma Announces the Publication of Positive Clinical Results from its Phase 2 Study of FMXIN002 (NS002) Intranasal Epinephrine Powder

Nasus Pharma Announces the Publication of Positive Clinical Results from its Phase 2 Study of FMXIN002 (NS002) Intranasal Epinephrine Powder

Nasus Pharma Ltd. ("Nasus Pharma" or the "Company"), a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based...

Nasus Pharma To Present Positive Clinical Results From Recent studies of FMXIN002 (NS002) Intranasal Epinephrine at the 2025 AAAAI Annual Meeting

Nasus Pharma To Present Positive Clinical Results From Recent studies of FMXIN002 (NS002) Intranasal Epinephrine at the 2025 AAAAI Annual Meeting

Nasus Pharma Ltd. ("Nasus Pharma" or the "Company"), a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Biotechnology

Biotechnology

Medical Pharmaceuticals

Medical Pharmaceuticals

Pharmaceuticals

Pharmaceuticals

News Releases in Similar Topics

Contact PR Newswire

  • Call PR Newswire at 888-776-0942
    from 8 AM - 9 PM ET
  • Chat with an Expert
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Italy
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom
  • Vietnam

My Services

  • All New Releases
  • Platform Login
  • ProfNet
  • Data Privacy

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Platform Login
  • ProfNet
Call PR Newswire at
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookies
Copyright © 2025 Cision US Inc.