TRI-STAR SOUR VII

المعلومات الرئيسية

  • اسم تجاري:
  • TRI-STAR SOUR VII
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • الجهاز الطبي

المستندات

  • لعامة الناس:
  • النشرة المعلومات عن هذا المنتج غير متوفر حاليا، يمكنك إرسال طلب لخدمة العملاء لدينا، ونحن سوف يخطر لك في أقرب وقت ونحن قادرون على الحصول عليه.


    طلب نشرة المعلومات لعامة الناس.

الأقلمة

  • متاح في:
  • TRI-STAR SOUR VII
    كازاخستان
  • اللغة:
  • العربية

معلومات أخرى

الحالة

  • المصدر:
  • Ecolab
  • تخويل:
  • 959783-07
  • اخر تحديث:
  • 12-03-2018

ملخص خصائص المنتج: الجرعة، والتفاعلات والآثار الجانبية

TRI-STAR SOUR VII

959783-07

1 / 9

TRI-STAR SOUR VII

0.03 % - 0.06 %

00971 4 8014444

00971 48146800 00971 4 8014000

0020 2 25 37 1195

00212 22 58 25 30 - 35

00971 4 8014444 :

00971 48146800 00971 4 8014000

0020 2 25 37 1195 :

00212 22 58 25 30 - 35 :

17.08.2017

GHS

TRI-STAR SOUR VII

959783-07

2 / 9

:

:

:

:

:

:

:

(%)

fluorosilicic acid

16961-83-4

10 - 30

77-92-9

5 - 10

TRI-STAR SOUR VII

959783-07

3 / 9

TRI-STAR SOUR VII

959783-07

4 / 9

0 °C

50 °C

fluorosilicic acid

16961-83-4

TWA (8 Hour)

2.5 mg/m3

TRI-STAR SOUR VII

959783-07

5 / 9

1.0 - 2.0

100 %

5.5 - 7.5

> 100 °C

1.12 - 1.32

TRI-STAR SOUR VII

959783-07

6 / 9

TRI-STAR SOUR VII

959783-07

7 / 9

2,025 mg/kg :

fluorosilicic acid

96 h :

LC50

50 mg/l :

96 h :

TRI-STAR SOUR VII

959783-07

8 / 9

LC50

> 100 mg/l :

(ADR/ADN/RID)

1778

FLUOROSILICIC ACID

)

(

1778

Fluorosilicic acid

TRI-STAR SOUR VII

959783-07

9 / 9

)

/

(

1778

FLUOROSILICIC ACID

17.08.2017

Regulatory Affairs

  • النشرة المعلومات عن هذا المنتج غير متوفر حاليا، يمكنك إرسال طلب لخدمة العملاء لدينا، ونحن سوف يخطر لك في أقرب وقت ونحن قادرون على الحصول عليه.

    طلب نشرة المعلومات لعامة الناس.



  • وثائق في اللغات الأخرى المتاحة هنا

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

5-12-2018

Public health risks associated with food‐borne parasites

Public health risks associated with food‐borne parasites

Published on: Tue, 04 Dec 2018 Parasites are important food‐borne pathogens. Their complex lifecycles, varied transmission routes, and prolonged periods between infection and symptoms mean that the public health burden and relative importance of different transmission routes are often difficult to assess. Furthermore, there are challenges in detection and diagnostics, and variations in reporting. A Europe‐focused ranking exercise, using multicriteria decision analysis, identified potentially food‐borne ...

Europe - EFSA - European Food Safety Authority Publications

5-12-2018

Hiland Dairy Announces Voluntary Recall of Hiland Dairy Half-Gallon Whole Chocolate Milk

Hiland Dairy Announces Voluntary Recall of Hiland Dairy Half-Gallon Whole Chocolate Milk

Hiland Dairy is announcing a voluntary recall of half-gallon premium whole milk chocolate that is produced at the Kansas City, Missouri facility, over concerns the products may contain eggnog that could affect those individuals that have sensitivity to egg allergens. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

30-11-2018

Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals

Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals

Published on: Thu, 29 Nov 2018 The study described in this report was conducted with the aim of developing an unified database of ecological data and residue data to be used for the risk assessment of plant protection products for birds and mammals. The main sources of data were the information submitted in the context of approval of active substances and authorization of products and and additional information retrieved through a systematic literature review. The data were screened and organised in thr...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the E

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the E

Published on: Mon, 26 Nov 2018 In the framework of the project ‘Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2’ a compendium of representative processing techniques was prepared as a result of Objective 1. In Objective 2 the food / feed items and processes as described in the compendium of Objective 1 were coded using the FoodEx2 coding system. The coding covers the raw agricultural commodities and the food / feed item...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray

First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray

First Source of Tonawanda, NY, is voluntarily recalling Chocolate and Nut Tray because it contains undeclared tree nuts, pecan and cashew. People who have an allergy or sensitivity to tree nuts (Pecan & Cashew) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

Indigo Books & Music Inc. recalls American Girl WellieWishers Magic Theater Play Tent

Indigo Books & Music Inc. recalls American Girl WellieWishers Magic Theater Play Tent

The play tent does not meet the requirements for tent flammability under Canadian law. The tents could catch fire if exposed to a flame or other ignition source, and pose possible fire and burn hazards to consumers.

Health Canada

13-11-2018

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor In...

FDA - U.S. Food and Drug Administration

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

3-11-2018

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

Nutrisca, of Saint Louis, Missouri is voluntarily recalling one formula of Nutrisca dry dog food (described below) due to it containing elevated levels of vitamin D.

FDA - U.S. Food and Drug Administration

3-11-2018

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

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

26-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

New Seasons Market is recalling 193 jars of New Seasons Market Hot & Sour Broth because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

10-10-2018

Resources for Animal Food Producers in Flooded Areas of Gulf Coast

Resources for Animal Food Producers in Flooded Areas of Gulf Coast

As Hurricane Michael makes landfall along the Florida Gulf Coast, FDA’s Center for Veterinary Medicine reminds those who may be affected by weather events about resources available for animal food producers who may be harvesting, mixing, storing or distributing grains and other foods for animals.

FDA - U.S. Food and Drug Administration

10-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

2-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

13-9-2018

Resources for Animal Food Producers in Flooded Areas

Resources for Animal Food Producers in Flooded Areas

FDA’s Center for Veterinary Medicine reminds those who may be affected by Hurricane Florence about resources available for animal food producers who may be harvesting, mixing, storing or distributing grains and other foods for animals.

FDA - U.S. Food and Drug Administration

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

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

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

15-8-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide in support of responsible opioid prescribing for safe, effective pain management in animals

FDA - U.S. Food and Drug Administration

14-8-2018

Koehler-Bright Star recalls WorkSafe 3-D cell flashlights

Koehler-Bright Star recalls WorkSafe 3-D cell flashlights

The flashlights are missing an encapsulation on the circuit board component which could allow the flashlight to ignite in an explosive environment, posing a burn hazard and risk of personal injury to the user or bystander.

Health Canada

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

8-8-2018

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

FDA approves first generic drug under Competitive Generic Therapy (CGT) designation for products with inadequate generic competition

FDA - U.S. Food and Drug Administration

27-7-2018

TeaSource Issues Allergy Alert on Undeclared Almonds in Product

TeaSource Issues Allergy Alert on Undeclared Almonds in Product

TeaSource of Roseville, MN is recalling Roasted Chestnut loose leaf tea, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product

FDA - U.S. Food and Drug Administration

19-7-2018

Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns

Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns

Portland French Bakery of Portland, OR is recalling 26,635 units of Seattle Sourdough Pub Bun 6pk and 8,022 units of Franz Premium Pub Buns 12pk, because it may contain undeclared SOY. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

20-11-2018

School administrators/teachers share the vital mission of educating today's youth. Their guidance and leadership develops our young people into tomorrow's leaders. We hope these resources are helpful in getting students/educators talking about the risks o

School administrators/teachers share the vital mission of educating today's youth. Their guidance and leadership develops our young people into tomorrow's leaders. We hope these resources are helpful in getting students/educators talking about the risks o

School administrators/teachers share the vital mission of educating today's youth. Their guidance and leadership develops our young people into tomorrow's leaders. We hope these resources are helpful in getting students/educators talking about the risks of e-cigarette use. pic.twitter.com/v4YHpyORXl

FDA - U.S. Food and Drug Administration

9-11-2018

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks.  http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4  pic.twitter.com/o2I1dYUQCx

FDA - U.S. Food and Drug Administration

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

17-10-2018

Save the date & Join the @US_FDA’s  Patient Engagement Advisory Committee on Nov 15th to discuss  patient-generated health data from sources like social media, activity  trackers, and patient-driven registries. Learn more:  https://go.usa.gov/xPRau  #Digi

Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #Digi

Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #DigitalHealth #PEAC2018 pic.twitter.com/NU61Snpxxw

FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

2-10-2018

Trizivir (ViiV Healthcare BV)

Trizivir (ViiV Healthcare BV)

Trizivir (Active substance: abacavir, lamivudine, zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6483 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/338/T/108

Europe -DG Health and Food Safety

2-10-2018

Telzir (ViiV Healthcare BV)

Telzir (ViiV Healthcare BV)

Telzir (Active substance: Fosamprenavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6468 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/534/T/93

Europe -DG Health and Food Safety

2-10-2018

Celsentri (ViiV Healthcare BV)

Celsentri (ViiV Healthcare BV)

Celsentri (Active substance: maraviroc) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6467 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/811/T/56

Europe -DG Health and Food Safety

27-9-2018

Read about how the FDA is seeking more resources in FY2019 to help  advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while  protecting patients. Click here:  https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.gov/xPWZ3  #mobilehealth

FDA - U.S. Food and Drug Administration

21-9-2018

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like  activity trackers, social media, and patient registries to better  understand their needs.  Click the link for more information about the upcoming meeting:  https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https://bit.ly/2MUNqhU 

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

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Active substance: vestronidase alfa) - Centralised - Authorisation - Commission Decision (2018)5714 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4438

Europe -DG Health and Food Safety

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

Among our efforts, one approach: the possible development of a public-private partnership – a CyberMed Safety Analysis Board - to complement existing device vulnerability and response mechanisms and serve as a resource for device makers and #FDA

Among our efforts, one approach: the possible development of a public-private partnership – a CyberMed Safety Analysis Board - to complement existing device vulnerability and response mechanisms and serve as a resource for device makers and #FDA

Among our efforts, one approach: the possible development of a public-private partnership – a CyberMed Safety Analysis Board - to complement existing device vulnerability and response mechanisms and serve as a resource for device makers and #FDA

FDA - U.S. Food and Drug Administration

22-7-2018

We'll consider regulatory options to speed up requiring companies to mitigate safety problems identified postmarket. Currently, mitigations such as new user training or new labeling can require rulemaking, which takes time and resources

We'll consider regulatory options to speed up requiring companies to mitigate safety problems identified postmarket. Currently, mitigations such as new user training or new labeling can require rulemaking, which takes time and resources

We'll consider regulatory options to speed up requiring companies to mitigate safety problems identified postmarket. Currently, mitigations such as new user training or new labeling can require rulemaking, which takes time and resources

FDA - U.S. Food and Drug Administration