Ֆինալգոն

main_info

  • trade_name:
  • Ֆինալգոն
  • dosage:
  • 4մգ/գ+25մգ/գ20գ ալյումինե պարկուճ և ներդրուկ
  • pharmaceutical_form:
  • քսուք
  • prescription_type:
  • Առանց դեղատոմսի
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Ֆինալգոն
    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

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

17-4-2019

Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection)

Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection)

Published on: Thu, 11 Apr 2019 According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-4-2019

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

FDA - U.S. Food and Drug Administration

11-4-2019

Evaluation of confirmatory data following the Article 12 MRL review for dimethenamid‐P

Evaluation of confirmatory data following the Article 12 MRL review for dimethenamid‐P

Published on: Wed, 10 Apr 2019 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethenamid‐P in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap refers to the submission of a plant metabolism study investigating the fate of dimethenamid‐P following foliar treatment with a short preharvest interval (PHI) in a leafy or bu...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-4-2019

FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

FDA approves a new treatment for osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).

FDA - U.S. Food and Drug Administration

9-4-2019

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who

Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects

FDA - U.S. Food and Drug Administration

9-4-2019

Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances

Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances

Published on: Mon, 08 Apr 2019 This document provides guidance to applicants submitting dossiers for approval of pesticide active substances, and to Member States preparing assessment reports on active substances within the scope of Regulation (EC) No 1107/2009 and Commission Implementing Regulation (EU) No 844/2012 and its subsequent amendments. It describes the administrative requirements for the preparation and submission of the dossier to support an application for the approval, the amendment of ap...

Europe - EFSA - European Food Safety Authority EFSA Journal

6-4-2019

Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Fri, 05 Apr 2019 In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the a...

Europe - EFSA - European Food Safety Authority EFSA Journal

6-4-2019

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)

Published on: Fri, 05 Apr 2019 Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead to modification of the original conclusions on their safety have been identified. The mol...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-4-2019

Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market

Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market

Published on: Thu, 04 Apr 2019 Guidance of the Panel on Genetically Modified Organisms (GMOs) of the European Food Safety Authority (EFSA) assists applicants in the preparation and presentation of their market registration applications by describing elements and information/data requirements for the risk assessment and monitoring of GMOs. This explanatory note to the guidance: (1) clarifies the scope and methodology for literature searching performed in the context of applications for market authorisati...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

3-4-2019

FDA takes new steps to increase access to adverse event report data for medical products used in animals

FDA takes new steps to increase access to adverse event report data for medical products used in animals

FDA takes new steps to increase access to adverse event report data for medical products used in animals

FDA - U.S. Food and Drug Administration

3-4-2019

Assessment of the application for renewal of the authorisation of Natuphos (3‐phytase) as a feed additive for poultry and pigs

Assessment of the application for renewal of the authorisation of Natuphos (3‐phytase) as a feed additive for poultry and pigs

Published on: Tue, 02 Apr 2019 Natuphos® is a feed additive that contains 3‐phytase which is produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, piglets (weaned) and pigs for fattening, laying hens and turkeys for fattening, ducks, sows, all minor avian species other than ducks and ornamental birds. This scientific opinion concerns the renewal of the authorisation of this additive for those species. The application also included chickens reared for la...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-4-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

FDA - U.S. Food and Drug Administration

2-4-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.

FDA - U.S. Food and Drug Administration

2-4-2019

FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications.

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

1-4-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes

FDA - U.S. Food and Drug Administration

29-3-2019

FDA approves new oral treatment for multiple sclerosis

FDA approves new oral treatment for multiple sclerosis

FDA approves Mayzent (cladribine), a new oral drug to treat multiple sclerosis

FDA - U.S. Food and Drug Administration

29-3-2019

End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency

End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency

The Danish Medicines Agency invites pharmaceutical companies, researchers and other interested parties to an end of day meeting on the new European recommendations on complex clinical trials which aim to support the development of personalised medicine.

Danish Medicines Agency

29-3-2019

Natugrain®Wheat TS/TS L

Natugrain®Wheat TS/TS L

Published on: Thu, 28 Mar 2019 Natugrain® Wheat TS is the trade name for a feed additive that contains endo‐1,4‐beta‐xylanase produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, turkeys for fattening or reared for breeding, ducks, ornamental birds and minor avian species (except ducks and laying birds). This scientific opinion concerns the renewal of the authorisation of this additive for those species. The applicant provided evidence that the additiv...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

FDA announced several new actions as part of our commitment to ensure sound regulatory oversight of tobacco products and an effective application review process that considers the impact on public health.

FDA - U.S. Food and Drug Administration

27-3-2019

FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

FDA approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.

FDA - U.S. Food and Drug Administration

27-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

FDA is taking new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

FDA - U.S. Food and Drug Administration

27-3-2019

Scientific advice on the Testbiotech's request for internal review of Commission Implementing Decision (EU) No 2018/2046 on maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations (application EFSA‐GMO‐BE‐2013‐118)

Scientific advice on the Testbiotech's request for internal review of Commission Implementing Decision (EU) No 2018/2046 on maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations (application EFSA‐GMO‐BE‐2013‐118)

Published on: Tue, 26 Mar 2019 Abstract Following a request of the European Commission, the European Food Safety Authority (EFSA) reviewed the scientific arguments raised by Testbiotech against the Commission Implementing Decision (EU) 2018/2046 authorising the placing on the market of products containing, consisting of, or produced from maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and its subcombinations (application EFSA‐GMO‐BE‐2013‐118). Testbiotech argued that the risk assessment of maize ...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-3-2019

FDA approves new oral drug to treat multiple sclerosis

FDA approves new oral drug to treat multiple sclerosis

The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

FDA - U.S. Food and Drug Administration

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

22-3-2019

Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and read across

Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and read across

Published on: Thu, 21 Mar 2019 To facilitate the practical implementation of the guidance on the residue definition for dietary risk assessment, EFSA has organized an evaluation of applicability of existing in silico models for predicting the genotoxicity of pesticides and their metabolites, including analysis of the impact on genotoxicity of the metabolic structural changes. The prediction ability of (Q)SARs for in vitro and in vivo tests were evaluated. For the Ames test, all (Q)SAR models generated s...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

FDA approves new device for treating moderate to severe chronic heart failure in patients

FDA approves new device for treating moderate to severe chronic heart failure in patients

Device to treat heart failure was given Breakthrough Device designation because it treats a life-threatening disease and addresses unmet clinical need.

FDA - U.S. Food and Drug Administration

21-3-2019

FDA Announces New Date for Webinar on Genome Editing in Animals

FDA Announces New Date for Webinar on Genome Editing in Animals

On April 25, 2019, FDA CVM, with participation from the CBER, will hold a public webinar about genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits.

FDA - U.S. Food and Drug Administration

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

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

19-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyond

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyond

New steps to strengthen FDA’s food safety program for 2020 and beyond

FDA - U.S. Food and Drug Administration

19-3-2019

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

Roger Genet, Director General of ANSES, and David Alis, President of the University of Rennes 1, today signed a scientific framework agreement aimed at strengthening their cooperation on environmental health, focused primarily on the "One Health" concept covering human, animal and plant health for the benefit of all. To mark this occasion, a conference and round table were organised on the theme of the exposome, one of the key issues at the heart of this new partnership between the two institutions.  

France - Agence Nationale du Médicament Vétérinaire

14-3-2019

FDA allows marketing of new device to help treat carbon monoxide poisoning

FDA allows marketing of new device to help treat carbon monoxide poisoning

FDA allows marketing of a new device, ClearMate, intended to be used with patients suffering from carbon monoxide poisoning. This is the first carbon monoxide poisoning device authorized for marketing by the FDA for use in an emergency room setting.

FDA - U.S. Food and Drug Administration

14-3-2019

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

FDA issues statement on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

FDA - U.S. Food and Drug Administration

14-3-2019

FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

Device is for treatment of patients to reduce mitral regurgitation in certain patients with heart failure symptoms who fail to respond to traditional therapy

FDA - U.S. Food and Drug Administration

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars.

FDA - U.S. Food and Drug Administration

13-3-2019

Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

Published on: Tue, 12 Mar 2019 An outbreak of 32 Salmonella enterica serotype Poona cases in infants and young children has recently been identified in France (30 cases), Belgium (one case) and Luxembourg (one case). All 32 patients were infected with the same bacterial strain based on core genome multilocus sequence typing analysis. All patients had onset of symptoms between August 2018 and February 2019. Information from interviews was available for 30 patients. All consumed one of three rice-based in...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-4-2019

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Active substance: Canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2964 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3683/R/11

Europe -DG Health and Food Safety

12-4-2019

Learn the latest news from @US_FDA about #MedicalDevices sterilized with ethylene oxide    https://go.usa.gov/xm47G  #FDA #Safety

Learn the latest news from @US_FDA about #MedicalDevices sterilized with ethylene oxide https://go.usa.gov/xm47G  #FDA #Safety

Learn the latest news from @US_FDA about #MedicalDevices sterilized with ethylene oxide https://go.usa.gov/xm47G  #FDA #Safety

FDA - U.S. Food and Drug Administration

10-4-2019

Versican Plus DHPPi/L4R (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4R (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4R (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis and rabies vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2850 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2759/R/14

Europe -DG Health and Food Safety

10-4-2019

Versican Plus L4 (Zoetis Belgium S.A.)

Versican Plus L4 (Zoetis Belgium S.A.)

Versican Plus L4 (Active substance: Canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2848 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3680/R/07

Europe -DG Health and Food Safety

10-4-2019

Versican Plus DHPPi/L4 (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4 (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4 (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2849 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3678/R/13

Europe -DG Health and Food Safety

10-4-2019

DuoResp Spiromax (Teva Pharma B.V.)

DuoResp Spiromax (Teva Pharma B.V.)

DuoResp Spiromax (Active substance: budesonide / formoterol) - Centralised - Renewal - Commission Decision (2019)2810 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002348/R/0027

Europe -DG Health and Food Safety

10-4-2019

BiResp Spiromax (Teva Pharma B.V.)

BiResp Spiromax (Teva Pharma B.V.)

BiResp Spiromax (Active substance: budesonide / formoterol) - Centralised - Renewal - Commission Decision (2019)2811 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/003890/R/0027

Europe -DG Health and Food Safety

4-4-2019

As FDA Commissioner, Dr. Gottlieb routinely played an integral role in unveiling newly-approved #MedicalDevices and the FDA’s plans to foster innovation and regulate #DigitalHealth technologies safely.pic.twitter.com/JX8Mi7up9t

As FDA Commissioner, Dr. Gottlieb routinely played an integral role in unveiling newly-approved #MedicalDevices and the FDA’s plans to foster innovation and regulate #DigitalHealth technologies safely.pic.twitter.com/JX8Mi7up9t

As FDA Commissioner, Dr. Gottlieb routinely played an integral role in unveiling newly-approved #MedicalDevices and the FDA’s plans to foster innovation and regulate #DigitalHealth technologies safely. pic.twitter.com/JX8Mi7up9t

FDA - U.S. Food and Drug Administration

4-4-2019

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Active substance: delamanid) - Centralised - Annual renewal - Commission Decision (2019)2687 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002552/R/0033

Europe -DG Health and Food Safety

4-4-2019

Sylvant (Janssen-Cilag International NV)

Sylvant (Janssen-Cilag International NV)

Sylvant (Active substance: siltuximab) - Centralised - Renewal - Commission Decision (2019)2713 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3708/R/0029

Europe -DG Health and Food Safety

4-4-2019

Gazyvaro (Roche Registration GmbH)

Gazyvaro (Roche Registration GmbH)

Gazyvaro (Active substance: obinutuzumab) - Centralised - Renewal - Commission Decision (2019)2712 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2799/R/0031

Europe -DG Health and Food Safety

3-4-2019

Read the FDA’s new discussion paper on a potential #TPLC approach to regulating #artificialintelligence and #machinelearning software as a medical device  https://go.usa.gov/xmc9J  #digitalhealth #healthtech

Read the FDA’s new discussion paper on a potential #TPLC approach to regulating #artificialintelligence and #machinelearning software as a medical device https://go.usa.gov/xmc9J  #digitalhealth #healthtech

Read the FDA’s new discussion paper on a potential #TPLC approach to regulating #artificialintelligence and #machinelearning software as a medical device https://go.usa.gov/xmc9J  #digitalhealth #healthtech

FDA - U.S. Food and Drug Administration

3-4-2019

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2673 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003473

Europe -DG Health and Food Safety

3-4-2019

EU/3/14/1378 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/14/1378 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/14/1378 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2672 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003420

Europe -DG Health and Food Safety

2-4-2019

Therapeutic Goods Order 54 - Standard for Disinfectants and Sterilants  (TGO 54)

Therapeutic Goods Order 54 - Standard for Disinfectants and Sterilants (TGO 54)

The new Standard for Disinfectants and Sanitary Products (TGO 104) came into effect on Monday 1 April 2019. It replaced TGO 54.

Therapeutic Goods Administration - Australia

29-3-2019

Versican Plus Pi (Zoetis Belgium S.A.)

Versican Plus Pi (Zoetis Belgium S.A.)

Versican Plus Pi (Active substance: Canine parainfluenza virus vaccine (live)) - Centralised - Renewal - Commission Decision (2019)2542 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3681/R/11

Europe -DG Health and Food Safety

29-3-2019

Versican Plus DHPPi (Zoetis Belgium S.A.)

Versican Plus DHPPi (Zoetis Belgium S.A.)

Versican Plus DHPPi (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live)) - Centralised - Renewal - Commission Decision (2019)2543 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3679/R/13

Europe -DG Health and Food Safety

29-3-2019


New gene therapy to treat rare inherited blood condition

New gene therapy to treat rare inherited blood condition

New gene therapy to treat rare inherited blood condition

Europe - EMA - European Medicines Agency

29-3-2019

Risk management plans for medicines and biologicals

Risk management plans for medicines and biologicals

Risk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form

Therapeutic Goods Administration - Australia

27-3-2019

The new proposed rule on mammography will require, for the first time under federal rules, that women receive information about breast density to better inform their healthcare decisions https://www.nytimes.com/2019/03/27/health/mammogram-dense-breast-can

The new proposed rule on mammography will require, for the first time under federal rules, that women receive information about breast density to better inform their healthcare decisions https://www.nytimes.com/2019/03/27/health/mammogram-dense-breast-can

The new proposed rule on mammography will require, for the first time under federal rules, that women receive information about breast density to better inform their healthcare decisions https://www.nytimes.com/2019/03/27/health/mammogram-dense-breast-cancer.html …

FDA - U.S. Food and Drug Administration

27-3-2019


New EudraVigilance system improves reporting of side effects and detection of safety signals

New EudraVigilance system improves reporting of side effects and detection of safety signals

New EudraVigilance system improves reporting of side effects and detection of safety signals

Europe - EMA - European Medicines Agency

19-3-2019

Fungitraxx (Avimedical B.V.)

Fungitraxx (Avimedical B.V.)

Fungitraxx (Active substance: Itraconazole) - Centralised - Renewal - Commission Decision (2019)2180 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/002722/R/0004

Europe -DG Health and Food Safety

14-3-2019

Webinar: Permitted indications for listed medicines

Webinar: Permitted indications for listed medicines

Webinar for small to medium businesses, start-ups, researchers and those new to regulation

Therapeutic Goods Administration - Australia