ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

المعلومات الرئيسية

  • اسم تجاري:
  • ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT
  • 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:
  • ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT
    كازاخستان
  • اللغة:
  • العربية

معلومات أخرى

الحالة

  • المصدر:
  • Ecolab
  • تخويل:
  • 913510
  • اخر تحديث:
  • 12-03-2018

ملخص خصائص المنتج: الجرعة، والتفاعلات والآثار الجانبية

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

1 / 9

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

0.58 % - 0.78 %

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 :

09.08.2017

GHS

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

2 / 9

:

:

:

:

:

(%)

Lactic acid

79-33-4

10 - 30

Sodium bisulfate

7681-38-1

5 - 10

25155-30-0

1 - 5

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

3 / 9

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

4 / 9

0 °C

50 °C

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

5 / 9

0.5 - 1.0

100 %

2.1 - 3.2

> 100 °C

1.069 - 1.135

907.757 mm2/s (40 °C)

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

6 / 9

> 5,000 mg/kg :

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

7 / 9

4 h :

> 2 mg/l :

5,000 mg/kg :

Lactic acid

96 h :

LC50

130 mg/l :

Sodium bisulfate

96 h :

LC50

7,960 mg/l :

96 h :

LC50

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

8 / 9

3.2 mg/l :

(ADR/ADN/RID)

)

(

)

ANTIMICROBIAL FRUIT & VEGETABLE TREATMENT

913510

9 / 9

IMDG/

(

09.08.2017

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

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

29-11-2018

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

FDA - U.S. Food and Drug Administration

26-11-2018

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).

FDA - U.S. Food and Drug Administration

21-11-2018

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

The FDA approved Gamifant (emapalumab-lzsg) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

FDA - U.S. Food and Drug Administration

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

FDA approves new drug to treat travelers’ diarrhea

FDA approves new drug to treat travelers’ diarrhea

FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

FDA - U.S. Food and Drug Administration

16-11-2018

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

FDA - U.S. Food and Drug Administration

14-11-2018

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.

FDA - U.S. Food and Drug Administration

13-11-2018

Questions on antimicrobial resistance

Questions on antimicrobial resistance

Antimicrobial resistance is a major public health issue in France: resistance to antibiotics calls into question the efficacy of treatments for infections occurring in humans and animals alike. At its annual symposium on this issue, ANSES will be presenting the result of its two reports on national trends in resistance in animals (Resapath report) and sales of veterinary antimicrobials.

France - Agence Nationale du Médicament Vétérinaire

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

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

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Manage Your Asthma: Know Your Triggers and Treatment Options

Manage Your Asthma: Know Your Triggers and Treatment Options

You can manage your asthma by taking medications approved by the FDA. Before going to the pharmacy, get a proper diagnosis from a doctor and together develop an asthma action plan.

FDA - U.S. Food and Drug Administration

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Sirob Imports, Inc. Issues Recall Due to Elevated Lead in Spices

Sirob Imports, Inc. Issues Recall Due to Elevated Lead in Spices

Sirob Imports, Inc of Lindenhurst, NY is recalling, Corrado, Orlando Imports, Nouri’s Syrian Bakery, Mediterranean Specialty Foods Brand and Butera Fruit Market Curry Powder because it contains elevated levels of lead.

FDA - U.S. Food and Drug Administration

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”

Feel Good Foods Inc. of Brooklyn, NY is recalling six lots of “Vegetable Fried Rice” frozen meals, UPC 00899039002129 because they may contain undeclared egg. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

15-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.

FDA - U.S. Food and Drug Administration

28-9-2018

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

FDA - U.S. Food and Drug Administration

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

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

14-9-2018

FDA approves device for treatment of acute coronary artery perforations

FDA approves device for treatment of acute coronary artery perforations

FDA approves device for treatment of acute coronary artery perforations

FDA - U.S. Food and Drug Administration

14-9-2018

FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings

FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings

CVM’s five-year action plan for supporting antimicrobial stewardship in veterinary settings builds upon the important steps CVM has taken to eliminate production uses of medically important antimicrobials.

FDA - U.S. Food and Drug Administration

13-9-2018

FDA approves new kind of treatment for hairy cell leukemia

FDA approves new kind of treatment for hairy cell leukemia

FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia

FDA - U.S. Food and Drug Administration

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

"My Medicines" ... This Brochure Can be a Lifesaver

"My Medicines" ... This Brochure Can be a Lifesaver

"My Medicines" a brochure offered by FDA's Office of Women's Health, can play a vital role in the medical treatment you receive during an emergency.

FDA - U.S. Food and Drug Administration

7-9-2018

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence.

FDA - U.S. Food and Drug Administration

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

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

13-11-2018

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA  encourages patients and caregivers to beware of illegally markets  diabetes treatments. Check out our Consumer Update on this issue  http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue http

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx  pic.twitter.com/OGwOusdP1w

FDA - U.S. Food and Drug Administration

1-11-2018

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here:  https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.usa.gov/xPysF  #MedicalDevice

FDA - U.S. Food and Drug Administration

26-10-2018

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options:  https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/aZBjgCGsB1

FDA - U.S. Food and Drug Administration

16-10-2018

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults:  https://go.usa.gov/xPNnH .pic.twitter.com/5mo0xuGCcK

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults: https://go.usa.gov/xPNnH .pic.twitter.com/5mo0xuGCcK

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults: https://go.usa.gov/xPNnH . pic.twitter.com/5mo0xuGCcK

FDA - U.S. Food and Drug Administration

10-10-2018

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIHpic.twitter.com/AwYhetCBiw

Diversity in research means more treatments work for more people. Join #ResearchDiversity Day on October 23rd for a day-long discussion of diversity in study recruitment and research. Join us! @Alzheimers_NIH pic.twitter.com/AwYhetCBiw

FDA - U.S. Food and Drug Administration

21-9-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

14-9-2018

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here:  https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

FDA - U.S. Food and Drug Administration

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

3-9-2018

Webinar: TGA fast track approval of prescription medicines: Information for health professionals

Webinar: TGA fast track approval of prescription medicines: Information for health professionals

To provide health professionals with information on how new pathways will contribute to providing treatment for patients with serious and life threatening conditions

Therapeutic Goods Administration - Australia