Դեվիտ

main_info

  • trade_name:
  • Դեվիտ 50000
  • dosage:
  • 1,25մգ (50 000ՄՄ)(15/1x15/) և (8/1x8/) բլիստերում
  • pharmaceutical_form:
  • դեղահատեր թաղանթապատ
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Դեվիտ 50000
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

  • source:
  • Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում - Armenia
  • last_update:
  • 31-05-2018

17-4-2019

Safety and efficacy of Biomin®DC‐C as a zootechnical feed additive for weaned piglets

Safety and efficacy of Biomin®DC‐C as a zootechnical feed additive for weaned piglets

Published on: Tue, 16 Apr 2019 The additive (trade name Biomin® DC‐C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l‐menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-4-2019

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with <em>Salmonella</em>

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with <em>Salmonella</em>

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella. The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272.

FDA - U.S. Food and Drug Administration

7-4-2019

Thorgensen Family Farm Recalls Raw Frozen Ground Pet Food (Rabbit; Duck; Llama; Pork) Because of Possible <em>Listeria Monocytogenes</em> Health Risk

Thorgensen Family Farm Recalls Raw Frozen Ground Pet Food (Rabbit; Duck; Llama; Pork) Because of Possible <em>Listeria Monocytogenes</em> Health Risk

Thogersen Family Farm of Stanwood, WA is voluntarily recalling raw frozen ground pet food because it has the potential to be contaminated with Listeria monocytogenes. The following varieties, packaged in two pound packs, are included in this recall: course ground rabbit, course ground mallard duck, ground llama, and ground pork frozen raw pet food

FDA - U.S. Food and Drug Administration

3-4-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

FDA shares its 2019 compounding priorities as the agency works to improve the quality of compounded drugs

FDA - U.S. Food and Drug Administration

29-3-2019

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Published on: Thu, 28 Mar 2019 This study applied a procedure for the identification of potential emerging chemical risks in the food chain to substances registered under the REACH Regulation that was previously developed and tested in an EFSA‐sponsored pilot study. The selection was limited to substances that (a) were registered with a full registration, (b) met eligibility criteria (e.g. availability of a CAS number and a SMILES notation) and (c) were considered to be inside the applicability domain o...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-3-2019

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA - U.S. Food and Drug Administration

11-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance

FDA is requesting new funding to continue to advance robust regulatory framework for oversight of e-cigarettes and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply.

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Published on: Mon, 25 Feb 2019 No abstract available. © European Food Safety Authority, 2015 Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Europe - EFSA - European Food Safety Authority EFSA Journal

21-2-2019

Gilda Industries, Inc. Issues Allergy Alert on Undeclared Milk in Butter Pound Cake

Gilda Industries, Inc. Issues Allergy Alert on Undeclared Milk in Butter Pound Cake

Gilda Industries, Inc voluntarily recalls select code dates and manufacturing lot numbers of Panque – Butter pound cake because they may contain undeclared milk . People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled panque –butter pound cake

FDA - U.S. Food and Drug Administration

25-1-2019

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Published on: Thu, 24 Jan 2019 The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain lev...

Europe - EFSA - European Food Safety Authority EFSA Journal

24-1-2019

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product.

FDA - U.S. Food and Drug Administration

22-1-2019

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

FDA - U.S. Food and Drug Administration

17-12-2018

December 13, 2018: Owner and Four Former Employees of New England Compounding Center Convicted Following Trial

December 13, 2018: Owner and Four Former Employees of New England Compounding Center Convicted Following Trial

December 13, 2018: Owner and Four Former Employees of New England Compounding Center Convicted Following Trial

FDA - U.S. Food and Drug Administration

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

10-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.

FDA - U.S. Food and Drug Administration

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

22-10-2018

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

FDA - U.S. Food and Drug Administration

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

FDA - U.S. Food and Drug Administration

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding

FDA - U.S. Food and Drug Administration

21-9-2018

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

CVM Update describing FDA Dear Veterinarian Letter about the differences between FDA-approved Mirataz (mirtazapine transdermal ointment), an animal drug with demonstrated safety and effectiveness to manage undesired weight loss in cats, and compounded formulations of transdermal mirtazapine.

FDA - U.S. Food and Drug Administration

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

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

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

7-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

16-8-2018

FDA approves first generic version of EpiPen

FDA approves first generic version of EpiPen

FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.

FDA - U.S. Food and Drug Administration

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues making progress on bulk drug substances for compounding

FDA - U.S. Food and Drug Administration

18-7-2018

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) an...

FDA - U.S. Food and Drug Administration

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)

Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)

Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066), decision type: , therapeutic area: , PIP number: P/0183/2014

Europe - EMA - European Medicines Agency

26-2-2019

&#039;Sartan&#039; blood pressure medicines

&#039;Sartan&#039; blood pressure medicines

TGA investigation - potential contamination with N-nitroso compounds

Therapeutic Goods Administration - Australia