Բենդամուստինի

main_info

  • trade_name:
  • Բենդամուստինի հիդրոքլորիդ 2.5մգ/մլ կաթիլաներարկման լուծույթի խտանյութի դեղափոշի
  • dosage:
  • 2,5մգ/մլ(1) և (5) ապակե սրվակ 50մլ
  • pharmaceutical_form:
  • դեղափոշի կաթիլաներարկման լուծույթի խտանյութի
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Բենդամուստինի հիդրոքլորիդ 2.5մգ/մլ կաթիլաներարկման լուծույթի խտանյութի դեղափոշի
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

23-4-2019

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

FDA - U.S. Food and Drug Administration

23-4-2019

Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls

Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls

New steps to strengthen the process of initiating voluntary recalls

FDA - U.S. Food and Drug Administration

22-4-2019

Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

The FDA wants to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella ...

FDA - U.S. Food and Drug Administration

19-4-2019

FDA approves first generic naloxone nasal spray to treat opioid overdose

FDA approves first generic naloxone nasal spray to treat opioid overdose

FDA granted approval of the 1st generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose

FDA - U.S. Food and Drug Administration

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

12-4-2019

Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

FDA - U.S. Food and Drug Administration

12-4-2019

Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk

Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk

FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices.

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

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

Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in

Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in

FDA issues statement on agency’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults

FDA - U.S. Food and Drug Administration

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

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

1-4-2019

FDA Approves PROIN ER Tablets for Controlling Urinary Incontinence in Dogs

FDA Approves PROIN ER Tablets for Controlling Urinary Incontinence in Dogs

The FDA’s Center for Veterinary Medicine announced today the approval of PROIN ER (phenylpropanolamine hydrochloride extended-release) tablets for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

FDA - U.S. Food and Drug Administration

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

Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

Helping to facilitate access to promising medicines for patients with serious or immediately life-threatening diseases or conditions when no comparable or satisfactory alternative therapy options are available is a high priority for the FDA.

FDA - U.S. Food and Drug Administration

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

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

26-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility. The FDA has been closely monitoring the situation and working with device manufacturers affected by the c...

FDA - U.S. Food and Drug Administration

22-3-2019

Safety and efficacy of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species

Safety and efficacy of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species

Published on: Thu, 21 Mar 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‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). O...

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

15-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

The FDA is working to further evaluate materials like metals that are used in medical devices to learn more about how these materials interact with the immune system.

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

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

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

8-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon

Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon

Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon

FDA - U.S. Food and Drug Administration

7-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

FDA updates draft guidance to set a clear path for the nonproprietary naming of interchangeable biosimilars.

FDA - U.S. Food and Drug Administration

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

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

FDA - U.S. Food and Drug Administration

4-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan.

FDA - U.S. Food and Drug Administration

28-2-2019


Call for scientific data for use in HMPC assessment work on ‘Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids (EMA/HMPC/328782/2016)’

Call for scientific data for use in HMPC assessment work on ‘Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids (EMA/HMPC/328782/2016)’

Call for scientific data for use in HMPC assessment work on ‘Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids (EMA/HMPC/328782/2016)’

Europe - EMA - European Medicines Agency

27-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony before the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations

Statement from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony before the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations

FDA addresses the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations

FDA - U.S. Food and Drug Administration

26-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

FDA outlines 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse.

FDA - U.S. Food and Drug Administration

25-2-2019

B&G Foods Voluntarily Recalls a Limited Number of Jars of Victoria® Marinara Sauce Due to Possible Undeclared Cashew

B&G Foods Voluntarily Recalls a Limited Number of Jars of Victoria® Marinara Sauce Due to Possible Undeclared Cashew

B&G Foods announced today it is voluntarily recalling 1,280 cases of a single date code of 40 oz. Victoria Marinara Sauce, with a “best by” date of 03/06/2022, after learning that the product may contain cashew allergens that are not declared on the product’s ingredient statement. People who have an allergy or severe sensitivity to cashew run the risk of serious or life-threatening allergic reaction if they consume this product. There is no health risk associated with this product for individuals without...

FDA - U.S. Food and Drug Administration

25-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food

American consumers expect a diverse, robust and fresh food supply that’s affordable and safe all year round. Since not all food products can be produced solely by domestic facilities, to help meet these demands, the U.S. imports about 15 percent of its overall food supply from more than 200 countries or territories representing about 125,000 international food facilities and farms. Over the past 15 years alone, we’ve seen a trend of rising imported foods. Other countries now supply about 32 percent of th...

FDA - U.S. Food and Drug Administration

22-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

FDA - U.S. Food and Drug Administration

24-4-2019


European Immunization Week 2019: statement by Executive Director Guido Rasi

European Immunization Week 2019: statement by Executive Director Guido Rasi

European Immunization Week 2019: statement by Executive Director Guido Rasi

Europe - EMA - European Medicines Agency

17-4-2019

ACCM meeting statement, Meeting 21, 28 March 2019

ACCM meeting statement, Meeting 21, 28 March 2019

Advisory Committee on Complementary Medicines meeting statement for 28 March 2019

Therapeutic Goods Administration - Australia

15-4-2019

EU/3/06/428 (Mundipharma Corporation (Ireland) Limited)

EU/3/06/428 (Mundipharma Corporation (Ireland) Limited)

EU/3/06/428 (Active substance: Forodesine hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2966 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004893

Europe -DG Health and Food Safety

15-4-2019

EU/3/06/421 (Mundipharma Corporation (Ireland) Limited)

EU/3/06/421 (Mundipharma Corporation (Ireland) Limited)

EU/3/06/421 (Active substance: Forodesine hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2965 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005745

Europe -DG Health and Food Safety

8-4-2019

ACV meeting statement, Meeting 11, 5 December 2018

ACV meeting statement, Meeting 11, 5 December 2018

Advisory Committee on Vaccines meeting statement is now available

Therapeutic Goods Administration - Australia

5-4-2019

ACSS public statement, 29-30 October 2018

ACSS public statement, 29-30 October 2018

The Public Statement for the Generic Medicines Working Group face-to-face meeting in Canberra, October 2018

Therapeutic Goods Administration - Australia

1-4-2019

EU/3/06/368 (Amicus Therapeutics Europe Limited)

EU/3/06/368 (Amicus Therapeutics Europe Limited)

EU/3/06/368 (Active substance: 1-deoxygalactonojirimycin hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2421 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004426

Europe -DG Health and Food Safety

27-3-2019


Orphan designation: Benserazide hydrochloride, The treatment of sickle cell disease, 11/01/2019, Positive

Orphan designation: Benserazide hydrochloride, The treatment of sickle cell disease, 11/01/2019, Positive

Orphan designation: Benserazide hydrochloride, The treatment of sickle cell disease, 11/01/2019, Positive

Europe - EMA - European Medicines Agency

22-3-2019

ACSS public statement, 14-15 May 2018

ACSS public statement, 14-15 May 2018

Public statement for the Generic Medicines Working Group face-to-face meeting in Switzerland, May 2018

Therapeutic Goods Administration - Australia

18-3-2019

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Active substance: Acebutolol hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2157 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004715

Europe -DG Health and Food Safety

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

15-3-2019

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Active substance: Apomorphine hydrochloride (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)2115 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004495

Europe -DG Health and Food Safety

6-3-2019

Fortekor and associated names

Fortekor and associated names

Fortekor and associated names (Active substance: Benazepril hydrochloride) - Corrigendum - Commission Decision (2012)772 of Wed, 06 Mar 2019

Europe -DG Health and Food Safety

1-3-2019

Medicines Advisory Statements Specification updates

Medicines Advisory Statements Specification updates

The new Therapeutic Goods (Medicines Advisory Statements) Specification 2019 commences 1 March 2019

Therapeutic Goods Administration - Australia

1-3-2019

ACV meeting statement, Meeting 10, 3 October 2018

ACV meeting statement, Meeting 10, 3 October 2018

Advisory Committee on Vaccines meeting statement is now available

Therapeutic Goods Administration - Australia

26-2-2019

EU/3/11/888 (DLRC Pharma Services Ltd)

EU/3/11/888 (DLRC Pharma Services Ltd)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1623 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003766

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/887 (DLRC Pharma Services Ltd)

EU/3/11/887 (DLRC Pharma Services Ltd)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1622 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003764

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/886 (DLRC Pharma Services Ltd)

EU/3/11/886 (DLRC Pharma Services Ltd)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1621 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003767

Europe -DG Health and Food Safety