FCP TTM STR PLAIN

Informazioni principali

  • Nome commerciale:
  • FCP TTM STR PLAIN
  • 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:
  • FCP TTM STR PLAIN
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • PINZE DA PRESA OFTALMICHE

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 14-11-2009
  • 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.

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Outcome of the Public Consultation on the draft Guidance on Communication of Uncertainty in Scientific Assessments

Outcome of the Public Consultation on the draft Guidance on Communication of Uncertainty in Scientific Assessments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 The draft Guidance document on communication of uncertainty underwent a web‐based public consultation from 4 May to 24 June 2018.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

20-12-2018

Pest categorisation of Grapholita inopinata

Pest categorisation of Grapholita inopinata

Published on: Wed, 19 Dec 2018 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Grapholita inopinata, (Lepidoptera: Tortricidae), the Manchurian fruit moth, for the territory of the EU. G. inopinata is a well‐defined species that is recognised as a major pest of Malus spp. in Far East Russia, Eastern Siberia and northern China. G. inopinata is less common in Japan where it is not a serious pest. G. inopinata is not known to occur in the EU. G. inopinata is listed in Annex IIAI of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-11-2018

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Since August 2014, the French Caribbean and French Guiana have been experiencing successive waves of Sargassum seaweed washing up on their coastlines. Despite the efforts made to clean it up, the seaweed decomposes in situ. This leads to the production of hydrogen sulphide (H2S), which can sometimes be detected at high concentrations. Doctors' reports concerning the health effects suffered by people exposed to H2S, and complaints from the general public relating to the problem of odours, have increased s...

France - Agence Nationale du Médicament Vétérinaire

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Nutrition Facts Label Reboot: A Tale of Two Labels

Nutrition Facts Label Reboot: A Tale of Two Labels

The Nutrition Facts Label (NFL) on packages consumers look at when they’re buying groceries or preparing a meal has undergone a makeover. The U.S. Food and Drug Administration (FDA) has changed it to reflect updated scientific findings and help consumers make better-informed choices about the foods their families eat. Until the deadlines, consumers may see two different versions on the products they buy: the original label they’ve been using, as well as the new label. The Consumer Update will emphasize...

FDA - U.S. Food and Drug Administration

13-9-2018

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

Danish Medicines Agency

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

28-8-2018

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

2-7-2018

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

FDA - U.S. Food and Drug Administration

29-6-2018

Talking Rain® Voluntarily Recalls Sparkling Ice® Cherry Limeade in Response to Customer Complaints

Talking Rain® Voluntarily Recalls Sparkling Ice® Cherry Limeade in Response to Customer Complaints

Talking Rain® (the Company) is voluntarily recalling specific lot codes of bottles of its Sparkling Ice® Cherry Limeade beverage in response to a small number of customer complaints that reported an off-taste and off-odor of the affected product. The Company made the decision to recall the product out of an abundance of caution.

FDA - U.S. Food and Drug Administration

26-6-2018

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

Huish Outdoors recalls Oceanic and Hollis Scuba Diving Regulators

The scuba diving regulators can restrict airflow at low tank pressures (below 500 psi), posing a drowning hazard to divers.

Health Canada

1-6-2018

Demulen 30 birth control pills: Packages containing broken or chipped pills

Demulen 30 birth control pills: Packages containing broken or chipped pills

Pfizer Canada Inc. has notified Health Canada that it has received complaints of broken or chipped pills involving Demulen 30, a prescription birth control pill. Health Canada has previously communicated on similar issues involving two other brands of birth control pills. Health Canada continues to remind women to check their packages of birth control pills and to report problems if they see them. If you notice anything unusual in the package, such as missing or damaged pills, you should return the packa...

Health Canada

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

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

16-4-2018

Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual

Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual

In light of continuing complaints of quality issues involving certain prescription birth control pills, Health Canada is reminding women to check their packages of birth control pills. If you notice anything unusual in the package, such as missing or damaged pills, you should return the package to the pharmacy for replacement as soon as possible. Skipping a dose because the pill is missing, or taking a damaged (for example, chipped or fragmented) pill, may increase the risk of pregnancy because less acti...

Health Canada

3-5-2016

New video graphics about the HPV vaccine

New video graphics about the HPV vaccine

The Danish Medicines Agency has made a video which explains how the authorities monitor the safety of the HPV vaccine.

Danish Medicines Agency

17-10-2014

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Danish Medicines Agency

1-4-2014

Danish Pharmacovigilance Update 27 February 2014

Danish Pharmacovigilance Update 27 February 2014

In this issue of Danish Pharmacovigilance Update: Further restrictions on the use of osteoporosis medicine strontium ranelate (Protelos®), Anticoagulant therapy to be stopped before initiating treatment with the new oral anticoagulants (NOACs).

Danish Medicines Agency

25-2-2014

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

The European Medicines Agency (EMA) recommends to restrict the use of the osteoporosis medicine strontium ranelate (Protelos®) to patients with severe osteoporosis who cannot be treated with other medicines approved for osteoporosis.

Danish Medicines Agency

6-9-2012

Danish Pharmacovigilance Update, 16 August 2012

Danish Pharmacovigilance Update, 16 August 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Maximum single dose of intravenous ondansetron (Zofran® and others) now restricted to 16 mg.

Danish Medicines Agency

19-6-2012

Danish Pharmacovigilance Update, 15 March 2012

Danish Pharmacovigilance Update, 15 March 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: A new registry study has investigated the frequency of malformations in newborns after treating the mother with antidepressants (SSRI) during the pregnancy.

Danish Medicines Agency

29-11-2018

TGA presentation: Advertising Therapeutic Goods to consumers - Complaints handling

TGA presentation: Advertising Therapeutic Goods to consumers - Complaints handling

An overview of the TGA's new advertising complaints handling framework.

Therapeutic Goods Administration - Australia

26-9-2018

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants https://bit.ly/2OU7wKX 

FDA - U.S. Food and Drug Administration

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

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration

22-7-2018

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market  https://bit.ly/2vnc1Zl   may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial equivalence.

FDA - U.S. Food and Drug Administration

22-7-2018

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network  https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting reversible contraception pic.twitter.com/TAWmVh99oL

FDA - U.S. Food and Drug Administration

12-7-2018

TGA presentations: The new Code - where are we at? 12 & 13 June 2018

TGA presentations: The new Code - where are we at? 12 & 13 June 2018

These presentations provided an update on the implementation of the new Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia

2-7-2018

Launch of new advertising hub and online complaints form

Launch of new advertising hub and online complaints form

Consumers can now report dodgy ads for medicines and medical devices through a single online form

Therapeutic Goods Administration - Australia

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

5-6-2018

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovation

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovation

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovationChallenge pic.twitter.com/QI0mrJactV

FDA - U.S. Food and Drug Administration

25-5-2018

The new Code - where are we at?

The new Code - where are we at?

Webinar and information session on the implementation of the Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia

2-5-2018

Consultation: Complaints handling - Advertising therapeutic goods to the public

Consultation: Complaints handling - Advertising therapeutic goods to the public

Consultation on proposed advertising complaints handling model. Closing date: 4 June 2018

Therapeutic Goods Administration - Australia

20-4-2018

The Poisons Standard and medical devices

The Poisons Standard and medical devices

New guidance explaining the labelling requirements of medical devices containing poisons

Therapeutic Goods Administration - Australia