TRACOE LARYNX PHON ASSIST I

Informazioni principali

  • Nome commerciale:
  • TRACOE LARYNX PHON ASSIST I
  • 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.


    Richiedi il foglio illustrativo per il pubblico.

  • 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:
  • TRACOE LARYNX PHON ASSIST I
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • CANNULE PER TRACHEOSTOMIA E PER LARINGECTOMIA - ACCESSORI

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 19-12-2009
  • 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.

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Published on: Wed, 19 Dec 2018 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recove

Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recove

The SUPPORT Act grants FDA additional authorities to meaningfully advance efforts to combat the crisis of opioid addiction plaguing our nation.

FDA - U.S. Food and Drug Administration

18-10-2018

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

The Flushmate II 501-B system can burst at or near the vessel weld seam releasing stored pressure. This pressure can lift the tank lid and shatter the tank, posing impact and laceration hazards to consumers and property damage.

Health Canada

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

5-10-2018

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on his or her own, without assistance from a health care provider.

FDA - U.S. Food and Drug Administration

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

6-8-2018

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

FDA - U.S. Food and Drug Administration

13-7-2018

FDA warns of imposters sending consumers fake warning letters

FDA warns of imposters sending consumers fake warning letters

FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.

FDA - U.S. Food and Drug Administration

6-7-2018

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

29-6-2018

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling certain lots of Prescript-Assist, a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, dairy, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

6-6-2018

Manufacturers Assistance and Technical Training Branch (MATTB)

Manufacturers Assistance and Technical Training Branch (MATTB)

CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide timely, accurate and useful information to stakeholders.

FDA - U.S. Food and Drug Administration

31-5-2018

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.

FDA - U.S. Food and Drug Administration

25-5-2018

Medical Devices Safety Update Volume 6, Number 3, May 2018

Medical Devices Safety Update Volume 6, Number 3, May 2018

How TGA uses joint replacement registry data; Focus on skills for vacuum-assisted births; TGA reviews product safety of ventilators

Therapeutic Goods Administration - Australia

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

22-5-2018

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

31-1-2017

We are extending our opening hours

We are extending our opening hours

From Wednesday 1 February 2017, we are extending our opening hours. This means that the reception will be open Monday to Friday from 8.30am to 3.30pm. You can also call us on our main telephone number during these hours.

Danish Medicines Agency

22-9-2016

Manufacturers and wholesale distributors must be contactable outside opening hours

Manufacturers and wholesale distributors must be contactable outside opening hours

The Danish Medicines Agency will make calls to companies' main phone numbers, or emergency lines, to check that wholesale distributors and pharmaceutical manufacturers are contactable outside normal opening hours and during holidays.

Danish Medicines Agency

9-1-2019

SME Assist workshop: 'Meeting Your Obligations' (Adelaide)

SME Assist workshop: 'Meeting Your Obligations' (Adelaide)

A face-to-face workshop covering the basics of regulation

Therapeutic Goods Administration - Australia

29-11-2018

Boxed Warning guidance

Boxed Warning guidance

Guidance to assist sponsors to understand their obligations and prescribers to understand the rationale

Therapeutic Goods Administration - Australia

27-11-2018

Reclassification of surgical mesh medical devices

Reclassification of surgical mesh medical devices

New guidance to assist sponsors with the reclassification of surgical mesh devices

Therapeutic Goods Administration - Australia

2-11-2018

How to determine if your product should be included in the ARTG

How to determine if your product should be included in the ARTG

Assistance for sponsors with products included in the ARTG as Class I medical devices to decide if their products are included correctly

Therapeutic Goods Administration - Australia

10-10-2018

As Hurricane #Michael nears land, take shelter & stay safe.

Follow weather updates on your phone or radio.

 In a tornado WARNING, go to an interior, windowless room.

 If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a closed attic. pic.twitter.com/KD5WZ7gamP

FDA - U.S. Food and Drug Administration

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration

19-9-2018

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding:  https://go

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding: https://go

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding: https://go.usa.gov/xP2y6  pic.twitter.com/r3c0i4pose

FDA - U.S. Food and Drug Administration

19-9-2018

Every disaster is different & each person has unique needs after #Florence. A variety of resources may be available to help with recovery:

Call 2-1-1 to connect with local sources of help.
 http://DisasterAssistance.gov  connects you with federal or volu

Every disaster is different & each person has unique needs after #Florence. A variety of resources may be available to help with recovery: Call 2-1-1 to connect with local sources of help. http://DisasterAssistance.gov  connects you with federal or volu

Every disaster is different & each person has unique needs after #Florence. A variety of resources may be available to help with recovery: Call 2-1-1 to connect with local sources of help. http://DisasterAssistance.gov  connects you with federal or voluntary organization resources. pic.twitter.com/UYuxr0yvF0

FDA - U.S. Food and Drug Administration

23-8-2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

MMDR implementation, SME Assist, GMP reforms, medicinal cannabis and international cooperation

Therapeutic Goods Administration - Australia

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

25-6-2018

Rapporto nazionale sull’uso dei farmaci in Italia 2017

Rapporto nazionale sull’uso dei farmaci in Italia 2017

È stato presentato oggi in AIFA il Rapporto Nazionale sull’uso dei Farmaci, che propone anche quest’anno una descrizione dettagliata dell’assistenza farmaceutica in Italia, fotografando un incremento rispetto al 2016 pari al 4,3% per i consumi e all’1,2% per la spesa farmaceutica nazionale totale.

Italia - AIFA - Agenzia Italiana del Farmaco

11-6-2018

.@CMSGov is issuing guidance today to make sure patients who use Continuous Glucose Monitors (CGMs) to help control their #diabetes can use apps on their smartphones in conjunction with CGM receivers. Learn more:  http://go.cms.gov/1jc4cdC 

.@CMSGov is issuing guidance today to make sure patients who use Continuous Glucose Monitors (CGMs) to help control their #diabetes can use apps on their smartphones in conjunction with CGM receivers. Learn more: http://go.cms.gov/1jc4cdC 

. @CMSGov is issuing guidance today to make sure patients who use Continuous Glucose Monitors (CGMs) to help control their #diabetes can use apps on their smartphones in conjunction with CGM receivers. Learn more: http://go.cms.gov/1jc4cdC 

FDA - U.S. Food and Drug Administration

29-5-2018

Ensure that you have optimised your Class I medical device ARTG entries

Ensure that you have optimised your Class I medical device ARTG entries

Information sheet to assist sponsors to optimise their Class I ARTG

Therapeutic Goods Administration - Australia

24-5-2018

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

FDA - U.S. Food and Drug Administration

8-5-2018

Child-resistant packaging requirements for medicines - Guidance on TGO 95

Child-resistant packaging requirements for medicines - Guidance on TGO 95

New guidance document published to assist medicine sponsors in meeting the requirements for child-resistant packaging (TGO 95)

Therapeutic Goods Administration - Australia

17-4-2018

Autologous skeletal myoblasts expanded ex vivo (Assistance Publique - Hopitaux de Paris (APHP))

Autologous skeletal myoblasts expanded ex vivo (Assistance Publique - Hopitaux de Paris (APHP))

Autologous skeletal myoblasts expanded ex vivo (Active substance: Autologous skeletal myoblasts expanded ex vivo) - Refusal of orphan designation - Commission Decision (2018)2354 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/144/17

Europe -DG Health and Food Safety