Կուրիոզին

main_info

  • trade_name:
  • Կուրիոզին
  • dosage:
  • 1,027մգ/գ15գ ալյումինե պարկուճ
  • pharmaceutical_form:
  • դոնդող
  • prescription_type:
  • Առանց դեղատոմսի
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Կուրիոզին
    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

Start pilots logeerzorg om mantelzorgers te ontlasten

Start pilots logeerzorg om mantelzorgers te ontlasten

Tien gemeenten starten met een pilot logeerzorg om mantelzorgers te ontlasten. Door logeerzorg kunnen ouderen die thuis zorg krijgen van bijvoorbeeld een partner tijdelijk in een zorginstelling ‘logeren’ zodat de mantelzorger even op adem kan komen. Het ministerie van VWS ondersteunt de gemeenten met 1 miljoen euro vanuit het programma Langer Thuis. Met het geld kunnen gemeenten onder meer een coördinator voor de logeerzorg aanstellen. Deze brengt de mogelijkheden voor logeerzorg onder de aandacht van ma...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-4-2019

Report on suspected side effects reported for medicinal cannabis

Report on suspected side effects reported for medicinal cannabis

Dizziness, nausea and concentration problems are some of the suspected side effects that have been reported to the Danish Medicines Agency in the first year of the medicinal cannabis pilot programme.

Danish Medicines Agency

29-3-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

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

7-2-2019

FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines

FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines

FDA announces pilot program to improve ability to trace prescription drugs at all points in the drug distribution chain.

FDA - U.S. Food and Drug Administration

16-1-2019

Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019

Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019

On 1 January 2019, a special reimbursement scheme for medicinal cannabis in the four-year pilot programme entered into force. Reimbursement is retroactive for purchases made in 2018.

Danish Medicines Agency

7-1-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications.

FDA - U.S. Food and Drug Administration

21-12-2018

3 miljoen voor pilots centra huiselijk geweld en kindermishandeling

3 miljoen voor pilots centra huiselijk geweld en kindermishandeling

In de strijd tegen huiselijk geweld maakt het kabinet 3 miljoen euro vrij voor de ontwikkeling van drie centra voor slachtoffers en plegers van huiselijk geweld en kindermishandeling. De centra komen in de regio’s Hart van Brabant, Rotterdam-Rijnmond en Kennemerland. Met het geld gaan zij hun aanpak verbreden. De pilots zullen in het eerste kwartaal van 2019 starten. Dat maken ministers Hugo de Jonge (VWS) en Sander Dekker (Rechtsbescherming) bekend.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

12-12-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in France and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in France and EFSA – Final report

Published on: Tue, 11 Dec 2018 The main goal of the Framework Partnership Agreement project is to put in place a relevant organisation in order to improve gathering, checking, storage and providing of data from national monitoring programs to EFSA. By accepting to participate in the pilot project, France has committed to implement several enhancement actions on the overall system of data collection and submission. This report describes the results of the implementations of these measures and presents th...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 This report describes the framework of collection, management and transmission of food safety data in the Federal Republic of Germany. To adjust optimally the data governance processes to the requirements defined by the EFSA, measures had been agreed upon in order to improve the specified situation. Subsequent methodological system enhancements related to data quality are given as well as structural adjustments and the development and implementation of suppo...

Europe - EFSA - European Food Safety Authority Publications

18-7-2018

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA - U.S. Food and Drug Administration

30-5-2018

12 applications for allocation of special funds related to medicinal cannabis

12 applications for allocation of special funds related to medicinal cannabis

The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.

Danish Medicines Agency

21-5-2018

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity

FDA - U.S. Food and Drug Administration

18-5-2018

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

FDA - U.S. Food and Drug Administration

21-3-2018

Infographic on the medicinal cannabis pilot programme

Infographic on the medicinal cannabis pilot programme

The Danish Medicines Agency has produced a short infographic film about the medicinal cannabis pilot programme. The film gives a brief introduction to the programme and is intended for sharing on social media.

Danish Medicines Agency

9-1-2018

DKMA Update December 2017

DKMA Update December 2017

In this issue of DKMA Update, you can read about the new medicinal cannabis pilot programme, about how to read the summary of product characteristics, and about two new studies on the use of contraceptive pills and adverse reactions.

Danish Medicines Agency

28-11-2017

The Icelandic Medicines
Agency starts publishing educational materials on its medicinal product
information website

The Icelandic Medicines Agency starts publishing educational materials on its medicinal product information website

Following a successful pilot project, the Icelandic Medicines Agency has decided to start publishing aRMM educational materials on its website: www.serlyfjaskra.is.

IMA - Icelandic Medicines Agency

5-10-2017

Collection of scientific experience for medicinal cannabis pilot programme

Collection of scientific experience for medicinal cannabis pilot programme

One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.

Danish Medicines Agency

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

5-1-2017

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

4-4-2019

During Dr. Gottlieb’s tenure, the #FDA made major strides in #DigitalHealth, launching a first-of-its-kind Software Precertification Pilot Program – a collaborative approach to building regulatory framework for rapidly-evolving technology #PreCert:  https

During Dr. Gottlieb’s tenure, the #FDA made major strides in #DigitalHealth, launching a first-of-its-kind Software Precertification Pilot Program – a collaborative approach to building regulatory framework for rapidly-evolving technology #PreCert: https

During Dr. Gottlieb’s tenure, the #FDA made major strides in #DigitalHealth, launching a first-of-its-kind Software Precertification Pilot Program – a collaborative approach to building regulatory framework for rapidly-evolving technology #PreCert: https://go.usa.gov/xmcFa .

FDA - U.S. Food and Drug Administration

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

8-3-2019

Today is the last day to provide comments to the #DigitalHealth #FDAPrecertPilot working model. Input will help shape the @US_FDA's next steps to build the #Pre-Cert program. Submit comments to the docket:  https://www.regulations.gov/docket?D=FDA-2017-N-

Today is the last day to provide comments to the #DigitalHealth #FDAPrecertPilot working model. Input will help shape the @US_FDA's next steps to build the #Pre-Cert program. Submit comments to the docket: https://www.regulations.gov/docket?D=FDA-2017-N-

Today is the last day to provide comments to the #DigitalHealth #FDAPrecertPilot working model. Input will help shape the @US_FDA's next steps to build the #Pre-Cert program. Submit comments to the docket: https://www.regulations.gov/docket?D=FDA-2017-N-4301 … #DigitalMedicine #HealthTech pic.twitter.com/iUsLNtkjTx

FDA - U.S. Food and Drug Administration

22-2-2019

A4. Patients & caregivers can share their stories and experiences living with a rare disease directly with #FDA through Rare Disease Listening Session pilot program. Learn more:  https://go.usa.gov/xEECU  #NIHchatpic.twitter.com/mVptIt3bTI

A4. Patients & caregivers can share their stories and experiences living with a rare disease directly with #FDA through Rare Disease Listening Session pilot program. Learn more: https://go.usa.gov/xEECU  #NIHchatpic.twitter.com/mVptIt3bTI

A4. Patients & caregivers can share their stories and experiences living with a rare disease directly with #FDA through Rare Disease Listening Session pilot program. Learn more: https://go.usa.gov/xEECU  #NIHchat pic.twitter.com/mVptIt3bTI

FDA - U.S. Food and Drug Administration

18-2-2019

EU/3/17/1956 (TxCell S.A.)

EU/3/17/1956 (TxCell S.A.)

EU/3/17/1956 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene) - Transfer of orphan designation - Commission Decision (2019)1371 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003578

Europe -DG Health and Food Safety

18-2-2019

EU/3/17/1955 (TxCell S.A.)

EU/3/17/1955 (TxCell S.A.)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2019)1370 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003576

Europe -DG Health and Food Safety

11-1-2019

Consultation: Good Clinical Practice Inspections Program

Consultation: Good Clinical Practice Inspections Program

The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019

Therapeutic Goods Administration - Australia

7-1-2019

Send your input on the #FDAPrecertPilot working model by March 8, 2019  https://go.usa.gov/xE2fZ  #DigitalMedicine #HealthTech

Send your input on the #FDAPrecertPilot working model by March 8, 2019 https://go.usa.gov/xE2fZ  #DigitalMedicine #HealthTech

Send your input on the #FDAPrecertPilot working model by March 8, 2019 https://go.usa.gov/xE2fZ  #DigitalMedicine #HealthTech

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

6-9-2018

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program:  https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa  #MedicalDevice pic.twitter.com/dOcFpbed9K

FDA - U.S. Food and Drug Administration

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

5-7-2018

International work-sharing pilot - Apalutamide (Erlyand)

International work-sharing pilot - Apalutamide (Erlyand)

Apalutamide (Erlyand) is the first medicine approved via ACSS Consortium’s NCE working group

Therapeutic Goods Administration - Australia

12-6-2018

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene) - Transfer of orphan designation - Commission Decision (2018)3811 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/168/17/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2018)3810 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/167/17/T/01

Europe -DG Health and Food Safety