Ապիդրա

main_info

  • trade_name:
  • Ապիդրա ներարկման լուծույթ նախալցված գրչում
  • dosage:
  • 100Մ/մլ(5) սոլոստար նախալցված գրիչներ 3մլ
  • pharmaceutical_form:
  • լուծույթ ե/մ ներարկման
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Ապիդրա ներարկման լուծույթ նախալցված գրչում
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

25-4-2019

Safety and efficacy of Levucell®SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for turkeys for fattening

Safety and efficacy of Levucell®SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for turkeys for fattening

Published on: Wed, 24 Apr 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 Levucell® SB when used in feed for turkeys for fattening. The additive is intended for use as a zootechnical additive (functional group: other additives) for the reduction of Salmonella contamination on carcasses through its decrease in faeces. In the context of a previo...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

17-4-2019

Assessment of the application for renewal of authorisation of GalliPro® (Bacillus subtilis DSM 17299) for chickens for fattening

Assessment of the application for renewal of authorisation of GalliPro® (Bacillus subtilis DSM 17299) for chickens for fattening

Published on: Tue, 16 Apr 2019 GalliPro® is the trade name for a feed additive based on viable cells of a strain of Bacillus subtilis intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. The product is currently authorised for use in chickens for fattening. This opinion concerns the renewal of this authorisation. Bacillus subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish the safety for the t...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

Pest survey card on Synchytrium endobioticum

Pest survey card on Synchytrium endobioticum

Published on: Wed, 03 Apr 2019 This pest survey card was prepared in the context of the EFSA mandate on plant pest surveillance (M‐2017‐0137), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, i...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

Pest survey card on Xanthomonas citri pv. citri and pv. aurantifolii

Pest survey card on Xanthomonas citri pv. citri and pv. aurantifolii

Published on: Wed, 03 Apr 2019 This pest survey card was prepared in the context of the EFSA mandate on plant pest surveillance (M‐2017‐0137), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, i...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

Pest survey card on non‐European isolates of citrus tristeza virus

Pest survey card on non‐European isolates of citrus tristeza virus

Published on: Wed, 03 Apr 2019 This pest survey card was prepared in the context of the EFSA mandate on plant pest surveillance (M‐2017‐0137), at the request of the European Commission. The purpose of the document is to assist the Member States to plan annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with current international standards. The data requirements for such an activity include the pest distribution, its host range, its b...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

Pest survey card on Huanglongbing and its vectors

Pest survey card on Huanglongbing and its vectors

Published on: Wed, 03 Apr 2019 This pest survey card was prepared in the context of the EFSA mandate on plant pest surveillance (M‐2017‐0137), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, i...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-4-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

FDA is announcing a public hearing to discuss access to affordable insulin products.

FDA - U.S. Food and Drug Administration

2-4-2019

Safety and efficacy of Hemicell®‐L (endo‐1,4‐β‐mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

Safety and efficacy of Hemicell®‐L (endo‐1,4‐β‐mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

Published on: Mon, 01 Apr 2019 The additive Hemicell®‐L is a liquid preparation of endo‐1,4‐β‐mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and cons...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-3-2019

Safety and efficacy of sorbitan monolaurate as a feed additive for all animal species

Safety and efficacy of sorbitan monolaurate as a feed additive for all animal species

Published on: Wed, 27 Mar 2019 The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. It is intended to be used as a technological additive, functional group: emulsifier, in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that sorbitan monolaurate is safe for all animal species at the proposed ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Assessment of the application for renewal of authorisation of Levucell SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for lambs and horses

Assessment of the application for renewal of authorisation of Levucell SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for lambs and horses

Published on: Thu, 21 Mar 2019 Levucell® SC is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae. The product is currently authorised for use in feed for horses, lambs, dairy sheep and dairy goats, dairy cows and cattle for fattening. This opinion concerns the renewal of the authorisation of Levucell® SC as a zootechnical additive for lambs and horses. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Published on: Wed, 20 Mar 2019 The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be establ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Probiotic Lactina® for chickens and rabbits

Probiotic Lactina® for chickens and rabbits

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the European Food Safety Authority 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 Probiotic Lactina® for chickens for fattening and rabbits. The additive is a preparation containing viable cells of six strains of lactic acid bacteria intended for use in feed at the proposed dose of 2.5 × 109CFU/kg complete feedingstuffs. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Assessment of the application for renewal of authorisation of Bonvital® (Enterococcus faecium DSM 7134) as a feed additive for weaned piglets and pigs for fattening

Assessment of the application for renewal of authorisation of Bonvital® (Enterococcus faecium DSM 7134) as a feed additive for weaned piglets and pigs for fattening

Published on: Tue, 19 Mar 2019 Bonvital® is the trade name for a feed additive based on Enterococcus faecium DSM 7134 currently authorised for use in piglets, pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. This opinion concerns the renewal of the authorisation of Bonvital® as a zootechnical additive for weaned piglets and pigs for fattening. The applicant is proposing to increase the minimum and maximum inclusion level of the additive in feed for ...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-3-2019

Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products

Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products

Out of an abundance of caution, today Claire’s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences.

FDA - U.S. Food and Drug Administration

8-3-2019

Safety and efficacy of Actisaf® Sc47 (Saccharomyces cerevisiae CNCM I‐4407) as a feed additive for cattle for fattening, dairy cows, weaned piglets and sows

Safety and efficacy of Actisaf® Sc47 (Saccharomyces cerevisiae CNCM I‐4407) as a feed additive for cattle for fattening, dairy cows, weaned piglets and sows

Published on: Thu, 07 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 Actisaf® Sc47 for dairy cows, cattle for fattening, weaned piglets and sows when used as a zootechnical additive. Actisaf® Sc47 consists of viable cells of a strain Saccharomyces cerevisiae and is marketed in three formulations. The FEEDAP Panel considers that the three ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Pest survey card on Popillia japonica

Pest survey card on Popillia japonica

Published on: Wed, 06 Mar 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the 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 Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of l‐valine produced using Corynebacterium glutamicum CGMCC 11675 for all animal species

Safety and efficacy of l‐valine produced using Corynebacterium glutamicum CGMCC 11675 for all animal species

Published on: Mon, 04 Mar 2019 The product subject of this assessment is l‐valine produced by fermentation with a strain of Corynebacterium glutamicum (CGMCC 11675). It is intended to be used in feed and water for drinking for all animal species and categories. Owing to the uncertainties regarding the possible genetic modification of the original production strain, the FEEDAP Panel cannot conclude on the safety of the additive l‐valine produced with C. glutamicum CGMCC 11675 for the target species, the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Published on: Fri, 01 Mar 2019 The additive Calsporin® is a preparation of viable spores of Bacillus subtilis DSM 15544, at a minimum declared concentration of 1 × 1010 colony forming units (CFU)/g additive. The additive is authorised as a zootechnical additive (functional group: gut flora stabiliser) for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, laying hens and ornamental fish, dogs, in sows and in suckli...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species

Published on: Thu, 28 Feb 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation with a genetically modified strain of Escherichia coli CGMCC 7.248 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli CGMCC 7.248 and its recombinant DNA were not detected in the f...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Aleurocanthus spiniferus and Aleurocanthus woglumi

Pest survey card on Aleurocanthus spiniferus and Aleurocanthus woglumi

Published on: Thu, 28 Feb 2019 Abstract This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its hos...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Clavibacter michiganensis subsp. sepedonicus

Pest survey card on Clavibacter michiganensis subsp. sepedonicus

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Tecia solanivora

Pest survey card on Tecia solanivora

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species

Safety and efficacy of l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species

Published on: Thu, 28 Feb 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ when used as a nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l‐threonine produced by fermentation with a ■■■■■ strain of C. glutamicum (■■■■■). l‐Threo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on potato brown rot, Ralstonia solanacearum

Pest survey card on potato brown rot, Ralstonia solanacearum

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Scirtothrips aurantii, Scirtothrips citri and Scirtothrips dorsalis

Pest survey card on Scirtothrips aurantii, Scirtothrips citri and Scirtothrips dorsalis

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA-Q2017-00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk-based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, i...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Epitrix cucumeris, Epitrix papa, Epitrix subcrinita and Epitrix tuberis

Pest survey card on Epitrix cucumeris, Epitrix papa, Epitrix subcrinita and Epitrix tuberis

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Ceratitis rosa and Ceratitis quilicii

Pest survey card on Ceratitis rosa and Ceratitis quilicii

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Meloidogyne chitwoodi and Meloidogyne fallax

Pest survey card on Meloidogyne chitwoodi and Meloidogyne fallax

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Toxoptera citricida

Pest survey card on Toxoptera citricida

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Globodera rostochiensis and Globodera pallida

Pest survey card on Globodera rostochiensis and Globodera pallida

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA - U.S. Food and Drug Administration

8-2-2019

FDA Announces Second Approved Insulin for Use in Dogs with Diabetes

FDA Announces Second Approved Insulin for Use in Dogs with Diabetes

The FDA’s Center for Veterinary Medicine announced today the approval of ProZinc (protamine zinc recombinant human insulin) for managing diabetes mellitus in dogs, the second approved insulin for use in dogs with diabetes.

FDA - U.S. Food and Drug Administration

1-2-2019

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-4-2019


Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Europe - EMA - European Medicines Agency

10-4-2019

Lantus (Sanofi-Aventis Deutschland GmbH)

Lantus (Sanofi-Aventis Deutschland GmbH)

Lantus (Active substance: insulin glargine) - Centralised - Yearly update - Commission Decision (2019)2815 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Actraphane (Novo Nordisk A/S)

Actraphane (Novo Nordisk A/S)

Actraphane (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2813 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

4-4-2019

Under Dr. Gottlieb, CDRH continued bringing innovative devices to market using a total product life-cycle approach. For example, expanded approval of an automated insulin dosing system for people age 7 and up with diabetes and the world’s smallest heart v

Under Dr. Gottlieb, CDRH continued bringing innovative devices to market using a total product life-cycle approach. For example, expanded approval of an automated insulin dosing system for people age 7 and up with diabetes and the world’s smallest heart v

Under Dr. Gottlieb, CDRH continued bringing innovative devices to market using a total product life-cycle approach. For example, expanded approval of an automated insulin dosing system for people age 7 and up with diabetes and the world’s smallest heart valve for newborns. pic.twitter.com/SNokx8QVXW

FDA - U.S. Food and Drug Administration

1-4-2019

NovoRapid (Novo Nordisk A/S)

NovoRapid (Novo Nordisk A/S)

NovoRapid (Active substance: Insulin aspart) - Centralised - Yearly update - Commission Decision (2019)2596 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

1-4-2019

Mixtard (Novo Nordisk A/S)

Mixtard (Novo Nordisk A/S)

Mixtard (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2598 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

1-4-2019

Insulatard (Novo Nordisk A/S)

Insulatard (Novo Nordisk A/S)

Insulatard (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2597 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

27-3-2019

Levemir (Novo Nordisk A/S)

Levemir (Novo Nordisk A/S)

Levemir (Active substance: insulin detemir) - Centralised - Yearly update - Commission Decision (2019)2389 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

22-3-2019


Summary of opinion: ProZinc,insulin human,  21/03/2019,  Positive

Summary of opinion: ProZinc,insulin human, 21/03/2019, Positive

Summary of opinion: ProZinc,insulin human, 21/03/2019, Positive

Europe - EMA - European Medicines Agency

15-3-2019

NovoMix (Novo Nordisk A/S)

NovoMix (Novo Nordisk A/S)

NovoMix (Active substance: Insulin aspart) - Centralised - 2-Monthly update - Commission Decision (2019)2114 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/000308/II/0095

Europe -DG Health and Food Safety

13-3-2019

Actrapid (Novo Nordisk A/S)

Actrapid (Novo Nordisk A/S)

Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2070 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

6-3-2019

Swimming is a fun way to enjoy your vacation. But keep your contact lenses out of the mix. Take lenses out before you swim to avoid getting germs in your eye that can lead to an infection.  https://go.usa.gov/pjwz  #SpringBreakpic.twitter.com/Bzanbae4iD

Swimming is a fun way to enjoy your vacation. But keep your contact lenses out of the mix. Take lenses out before you swim to avoid getting germs in your eye that can lead to an infection. https://go.usa.gov/pjwz  #SpringBreakpic.twitter.com/Bzanbae4iD

Swimming is a fun way to enjoy your vacation. But keep your contact lenses out of the mix. Take lenses out before you swim to avoid getting germs in your eye that can lead to an infection. https://go.usa.gov/pjwz  #SpringBreak pic.twitter.com/Bzanbae4iD

FDA - U.S. Food and Drug Administration

4-3-2019

Packing contact lenses for your #SpringBreak adventure? Bring your contact lens supplies to help keep your eyes healthy.  https://go.usa.gov/xEgaz pic.twitter.com/TcuoRiFyCT

Packing contact lenses for your #SpringBreak adventure? Bring your contact lens supplies to help keep your eyes healthy. https://go.usa.gov/xEgaz pic.twitter.com/TcuoRiFyCT

Packing contact lenses for your #SpringBreak adventure? Bring your contact lens supplies to help keep your eyes healthy. https://go.usa.gov/xEgaz  pic.twitter.com/TcuoRiFyCT

FDA - U.S. Food and Drug Administration

4-3-2019

Going on a trip this #springbreak? Protect your eyes. Pack extra contact lens supplies in your #travel health kit just in case you need them.  https://bit.ly/2H7gX8X pic.twitter.com/u0KQl03Pax

Going on a trip this #springbreak? Protect your eyes. Pack extra contact lens supplies in your #travel health kit just in case you need them. https://bit.ly/2H7gX8X pic.twitter.com/u0KQl03Pax

Going on a trip this #springbreak? Protect your eyes. Pack extra contact lens supplies in your #travel health kit just in case you need them. https://bit.ly/2H7gX8X  pic.twitter.com/u0KQl03Pax

FDA - U.S. Food and Drug Administration

1-3-2019


New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Europe - EMA - European Medicines Agency

27-2-2019

Fiasp (Novo Nordisk A/S)

Fiasp (Novo Nordisk A/S)

Fiasp (Active substance: insulin aspart) - Centralised - Yearly update - Commission Decision (2019)1687 of Wed, 27 Feb 2019

Europe -DG Health and Food Safety

26-2-2019

Survey of human insulin products

Survey of human insulin products

The TGA has tested a range of human insulin products and all met the applicable quality standards

Therapeutic Goods Administration - Australia

25-2-2019

The FDA is alerting women, health care providers, and people getting  breast cancer screening, that thermography should not replace  mammography for breast cancer screening or diagnosis. Find out more  about the risks and #FDA Recommendations  https://go.

The FDA is alerting women, health care providers, and people getting breast cancer screening, that thermography should not replace mammography for breast cancer screening or diagnosis. Find out more about the risks and #FDA Recommendations https://go.

The FDA is alerting women, health care providers, and people getting breast cancer screening, that thermography should not replace mammography for breast cancer screening or diagnosis. Find out more about the risks and #FDA Recommendations https://go.usa.gov/xEyeh?utm_source=CDRHTwitterD … pic.twitter.com/hvKVSbHAOG

FDA - U.S. Food and Drug Administration

19-2-2019


Orphan designation: Glucagon, Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 19/11/2018, Positive

Orphan designation: Glucagon, Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 19/11/2018, Positive

Orphan designation: Glucagon, Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

15-2-2019

#ICYMI: FDA authorizes first interoperable insulin pump intended to  allow patients to customize treatment through their individual diabetes  management devices. Read more here:  https://go.usa.gov/xEUuM   #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

14-2-2019

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Active substance: Recombinant human monoclonal antibody to insulin receptor) - Transfer of orphan designation - Commission Decision (2019)1372 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003601

Europe -DG Health and Food Safety

14-2-2019

Liprolog (Eli Lilly Nederland B.V.)

Liprolog (Eli Lilly Nederland B.V.)

Liprolog (Active substance: Insulin lispro) - Centralised - Yearly update - Commission Decision (2019)1331 of Thu, 14 Feb 2019

Europe -DG Health and Food Safety

1-2-2019


First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency