Գազիվա

main_info

  • trade_name:
  • Գազիվա
  • dosage:
  • 1000մգ/40մլ(1) ապակե սրվակ 40մլ
  • pharmaceutical_form:
  • խտանյութ կաթիլաներարկման լուծույթի
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Գազիվա
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

25-4-2019

Software for National Risk Assessment Activities

Software for National Risk Assessment Activities

Published on: Wed, 24 Apr 2019 In specific contract No 9 issued under the framework agreement OC/EFSA/AMU/2015/02, EFSA requested Open Analytics to implement a web application for tracking national risk assessment activities. The web application has three modules: one for visualization of the data, one for editing risk assessment activities and one for managing purposes. Functionalities of the edit module are set according the type of user that has logged into the web application. There are three user t...

Europe - EFSA - European Food Safety Authority EFSA Journal

24-4-2019

Enforcement Report for the Week of April 24, 2019

Enforcement Report for the Week of April 24, 2019

Recently Updated Records for the Week of April 24, 2019 Last Modified Date: Tuesday, April 23, 2019

FDA - U.S. Food and Drug Administration

23-4-2019

Breakdown of FDAAA Completed Pediatric Studies

Breakdown of FDAAA Completed Pediatric Studies

(updated)

FDA - U.S. Food and Drug Administration

18-4-2019

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP

FDA - U.S. Food and Drug Administration

18-4-2019

Systematic review on health outcomes related to the age of introduction of complementary food

Systematic review on health outcomes related to the age of introduction of complementary food

Published on: Wed, 17 Apr 2019 In 2016, the European Commission gave EFSA a mandate to update its 2009 opinion on the appropriate age for introduction of complementary feeding of infants. In order to retrieve data on health outcomes related to the age of introduction of complementary food, a systematic literature review will be conducted by EFSA. This report presents the preparatory work that is performed by Pallas, with advice of Wageningen University, for the systematic literature review. It provides ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-4-2019

Enforcement Report for the Week of April 17, 2019

Enforcement Report for the Week of April 17, 2019

Recently Updated Records for the Week of April 17, 2019 Last Modified Date: Tuesday, April 16, 2019

FDA - U.S. Food and Drug Administration

15-4-2019

Enforcement Report for the Week of May 24, 2017

Enforcement Report for the Week of May 24, 2017

Recently Updated Records for the Week of May 24, 2017 Last Modified Date: Monday, April 15, 2019

FDA - U.S. Food and Drug Administration

15-4-2019

Food additive E171: ANSES reiterates its recommendations for consumer safety

Food additive E171: ANSES reiterates its recommendations for consumer safety

The food additive E171, which consists of titanium dioxide (TiO2) particles, mainly in nanoparticle form, is used in many different food products. Following the expert appraisal work it conducted in 2017, ANSES was asked in February 2019 to review the most recent studies on the oral toxicology of E171 and to update its recommendations. On completion of this expert appraisal, the Agency concluded that it had not obtained any new information to resolve the uncertainties regarding the safety of the additive...

France - Agence Nationale du Médicament Vétérinaire

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

12-4-2019

Fluoroquinolone antibiotics and risk of aortic aneurysm/dissection

Fluoroquinolone antibiotics and risk of aortic aneurysm/dissection

Medicines Safety Update - TGA investigating fluoroquinolone antibiotics and risk of aortic aneurysm/dissection

Therapeutic Goods Administration - Australia

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

10-4-2019

Outcome of the public consultation on the draft administrative guidance on the preparation and presentation of applications for authorisation of additives for use in animal nutrition

Outcome of the public consultation on the draft administrative guidance on the preparation and presentation of applications for authorisation of additives for use in animal nutrition

Published on: Tue, 09 Apr 2019 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft administrative guidance on the preparation and presentation of applications for authorisation of additives for use in animal nutrition (update 2019) prepared by the EFSA Applications Desk Unit to support applicants in preparing applications for authorisation of feed additive. The written public consultation for t...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-4-2019

Enforcement Report for the Week of April 03, 2019

Enforcement Report for the Week of April 03, 2019

Recently Updated Records for the Week of April 03, 2019 Last Modified Date: Monday, April 08, 2019

FDA - U.S. Food and Drug Administration

6-4-2019

Outcome of the public consultation on the draft guidance on the assessment of the safety of feed additives for the environment

Outcome of the public consultation on the draft guidance on the assessment of the safety of feed additives for the environment

Published on: Fri, 05 Apr 2019 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft guidance on the assessment of the safety of feed additives for the environment prepared by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and endorsed by the Panel for public consultation at its Plenary meeting on 2 October 2018. The written public consultation for this docume...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-4-2019


Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS, European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019

Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS, European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019

Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS, European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019

Europe - EMA - European Medicines Agency

30-3-2019

Pesticide Residue Intake Model‐ EFSA PRIMo revision 3.1

Pesticide Residue Intake Model‐ EFSA PRIMo revision 3.1

Published on: Fri, 29 Mar 2019 In January 2018, the guidance document on the use of EFSA PRIMo revision 3 was published in the EFSA Journal. Following feedback from users, the risk assessment tool has been updated, including editorial modifications and corrections of input values used for the calculation of the exposure assessments. This technical report summarises the modifications introduced in EFSA PRIMo revision 3.1. © European Food Safety Authority, 2015 Pesticide Residue Intake Model‐ EFSA PRIMo ...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-3-2019

Mammography: What You Need to Know

Mammography: What You Need to Know

Mammograms are still the best primary tool for breast cancer screening. To continue to protect women's health, the FDA is proposing updates to the mammography regulations to reflect advances in mammography technology and processes.

FDA - U.S. Food and Drug Administration

27-3-2019

Enforcement Report for the Week of March 27, 2019

Enforcement Report for the Week of March 27, 2019

Recently Updated Records for the Week of March 27, 2019 Last Modified Date: Wednesday, March 20, 2019

FDA - U.S. Food and Drug Administration

26-3-2019

Enforcement Report for the Week of October 26, 2016

Enforcement Report for the Week of October 26, 2016

Recently Updated Records for the Week of October 26, 2016 Last Modified Date: Tuesday, March 26, 2019

FDA - U.S. Food and Drug Administration

24-4-2019

Clopidogrel Apotex (Apotex Europe B.V.)

Clopidogrel Apotex (Apotex Europe B.V.)

Clopidogrel Apotex (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2019)3158 of Wed, 24 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Leganto (UCB Pharma S.A.)

Leganto (UCB Pharma S.A.)

Leganto (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2019)2992 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Lokelma (AstraZeneca AB)

Lokelma (AstraZeneca AB)

Lokelma (Active substance: sodium zirconium cyclosilicate) - Centralised - Yearly update - Commission Decision (2019)2987 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Convenia (Zoetis Belgium S.A.)

Convenia (Zoetis Belgium S.A.)

Convenia (Active substance: Cefovecin) - Centralised - Yearly update - Commission Decision (2019)2996 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Suvaxyn PRRS MLV (Zoetis Belgium S.A.)

Suvaxyn PRRS MLV (Zoetis Belgium S.A.)

Suvaxyn PRRS MLV (Active substance: Porcine respiratory and reproductive syndrome virus vaccine (live)) - Centralised - Yearly update - Commission Decision (2019)2995 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Lamivudine Teva (Teva B.V.)

Lamivudine Teva (Teva B.V.)

Lamivudine Teva (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2019)2994 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Pemetrexed Lilly (Eli Lilly Nederland B.V.)

Pemetrexed Lilly (Eli Lilly Nederland B.V.)

Pemetrexed Lilly (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2019)2986 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Zutectra (Biotest Pharma GmbH)

Zutectra (Biotest Pharma GmbH)

Zutectra (Active substance: Human Hepatitis B Immunoglobulin) - Centralised - Yearly update - Commission Decision (2019)2974 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Pregabalin Zentiva (Zentiva, k.s.)

Pregabalin Zentiva (Zentiva, k.s.)

Pregabalin Zentiva (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2019)2990 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Spherox (CO.DON AG)

Spherox (CO.DON AG)

Spherox (Active substance: spheroids of human autologous matrix-associated chondrocytes) - Centralised - Yearly update - Commission Decision (2019)2972 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Cervarix (GlaxoSmithKline Biologicals S.A.)

Cervarix (GlaxoSmithKline Biologicals S.A.)

Cervarix (Active substance: Human Papilloma Virus-16 and Human Papilloma Virus 18 L1 proteins) - Centralised - Yearly update - Commission Decision (2019)2973 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

12-4-2019


Update of EU recommendations for 2019/2020 seasonal flu vaccine composition

Update of EU recommendations for 2019/2020 seasonal flu vaccine composition

Update of EU recommendations for 2019/2020 seasonal flu vaccine composition

Europe - EMA - European Medicines Agency

11-4-2019

Esbriet (Roche Registration GmbH)

Esbriet (Roche Registration GmbH)

Esbriet (Active substance: Pirfenidone) - Centralised - Yearly update - Commission Decision (2019)2883 of Thu, 11 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Iressa (AstraZeneca AB)

Iressa (AstraZeneca AB)

Iressa (Active substance: gefitinib) - Centralised - Yearly update - Commission Decision (2019)2823 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Lantus (Sanofi-Aventis Deutschland GmbH)

Lantus (Sanofi-Aventis Deutschland GmbH)

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

Europe -DG Health and Food Safety

10-4-2019

Zerit (Bristol-Myers Squibb Pharma EEIG)

Zerit (Bristol-Myers Squibb Pharma EEIG)

Zerit (Active substance: Stavudine) - Centralised - Yearly update - Commission Decision (2019)2819 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Actraphane (Novo Nordisk A/S)

Actraphane (Novo Nordisk A/S)

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

Europe -DG Health and Food Safety

10-4-2019

Orencia (Bristol-Myers Squibb Pharma EEIG)

Orencia (Bristol-Myers Squibb Pharma EEIG)

Orencia (Active substance: abatacept) - Centralised - Yearly update - Commission Decision (2019)2818 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

5-4-2019

Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)

Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)

Update to BIA-ALCL health professional web page following banning of macro-textured and polyurethane-coated breast implants in France

Therapeutic Goods Administration - Australia

4-4-2019

Yervoy (Bristol-Myers Squibb/Pfizer EEIG)

Yervoy (Bristol-Myers Squibb/Pfizer EEIG)

Yervoy (Active substance: ipilimumab) - Centralised - Yearly update - Commission Decision (2019)2704 of Thu, 04 Apr 2019

Europe -DG Health and Food Safety

4-4-2019

NULOJIX (Bristol-Myers Squibb/Pfizer EEIG)

NULOJIX (Bristol-Myers Squibb/Pfizer EEIG)

NULOJIX (Active substance: belatacept) - Centralised - Yearly update - Commission Decision (2019)2703 of Thu, 04 Apr 2019

Europe -DG Health and Food Safety

4-4-2019

Clopidogrel BGR (Laboratoires BIOGARAN)

Clopidogrel BGR (Laboratoires BIOGARAN)

Clopidogrel BGR (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2019)2694 of Thu, 04 Apr 2019

Europe -DG Health and Food Safety

4-4-2019

Empliciti (Bristol-Myers Squibb Pharma EEIG)

Empliciti (Bristol-Myers Squibb Pharma EEIG)

Empliciti (Active substance: elotuzumab) - Centralised - Yearly update - Commission Decision (2019)2692 of Thu, 04 Apr 2019

Europe -DG Health and Food Safety

4-4-2019

Zonisamide Mylan (Mylan S.A.S.)

Zonisamide Mylan (Mylan S.A.S.)

Zonisamide Mylan (Active substance: zonisamide) - Centralised - Yearly update - Commission Decision (2019)2715 of Thu, 04 Apr 2019

Europe -DG Health and Food Safety

1-4-2019

NovoRapid (Novo Nordisk A/S)

NovoRapid (Novo Nordisk A/S)

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

Europe -DG Health and Food Safety

1-4-2019

Mixtard (Novo Nordisk A/S)

Mixtard (Novo Nordisk A/S)

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

Europe -DG Health and Food Safety

1-4-2019

Insulatard (Novo Nordisk A/S)

Insulatard (Novo Nordisk A/S)

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

Europe -DG Health and Food Safety

1-4-2019

Imatinib Teva (Teva B.V.)

Imatinib Teva (Teva B.V.)

Imatinib Teva (Active substance: imatinib) - Centralised - Yearly update - Commission Decision (2019)2595 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

1-4-2019

Lamivudine / Zidovudine Teva (Teva B.V.)

Lamivudine / Zidovudine Teva (Teva B.V.)

Lamivudine / Zidovudine Teva (Active substance: Lamivudine / Zidovudine) - Centralised - Yearly update - Commission Decision (2019)2576 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

1-4-2019

Clopidogrel Krka (Krka d. d., Novo mesto)

Clopidogrel Krka (Krka d. d., Novo mesto)

Clopidogrel Krka (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2019)2594 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

1-4-2019

VPRIV (Shire Pharmaceuticals Ireland Limited)

VPRIV (Shire Pharmaceuticals Ireland Limited)

VPRIV (Active substance: Velaglucerase alfa) - Centralised - Yearly update - Commission Decision (2019)2575 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

29-3-2019

Activyl Tick Plus (Intervet International B.V.)

Activyl Tick Plus (Intervet International B.V.)

Activyl Tick Plus (Active substance: Indoxacarb + permethrin) - Centralised - Yearly update - Commission Decision (2019)2544 of Fri, 29 Mar 2019

Europe -DG Health and Food Safety

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

29-3-2019

Submission of an updated RMP

Submission of an updated RMP

Use this form when submitting an updated RMP after regulatory approval

Therapeutic Goods Administration - Australia

29-3-2019

GMP clearance guidance update

GMP clearance guidance update

We have published Version 18.2 of the GMP clearance guidance

Therapeutic Goods Administration - Australia

27-3-2019

Clopidogrel Mylan (Mylan S.A.S.)

Clopidogrel Mylan (Mylan S.A.S.)

Clopidogrel Mylan (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2019)2388 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

27-3-2019

Levemir (Novo Nordisk A/S)

Levemir (Novo Nordisk A/S)

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

Europe -DG Health and Food Safety

27-3-2019

Baraclude (Bristol-Myers Squibb Pharma EEIG)

Baraclude (Bristol-Myers Squibb Pharma EEIG)

Baraclude (Active substance: entecavir) - Centralised - Yearly update - Commission Decision (2019)2391 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

27-3-2019

Edarbi (Takeda Pharma A/S)

Edarbi (Takeda Pharma A/S)

Edarbi (Active substance: azilsartan medoxomil) - Centralised - Yearly update - Commission Decision (2019)2386 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

27-3-2019

Zyllt (Krka d. d., Novo mesto)

Zyllt (Krka d. d., Novo mesto)

Zyllt (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2019)2377 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

27-3-2019

Clopidogrel ratiopharm GmbH (Archie Samuel s.r.o.)

Clopidogrel ratiopharm GmbH (Archie Samuel s.r.o.)

Clopidogrel ratiopharm GmbH (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2019)2390 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

27-3-2019

ADYNOVI (Baxalta Innovations GmbH)

ADYNOVI (Baxalta Innovations GmbH)

ADYNOVI (Active substance: rurioctocog alfa pegol) - Centralised - Yearly update - Commission Decision (2019)2378 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

27-3-2019

Lutathera (Advanced Accelerator Applications)

Lutathera (Advanced Accelerator Applications)

Lutathera (Active substance: lutetium (177Lu) oxodotreotide) - Centralised - Yearly update - Commission Decision (2019)2376 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

20-3-2019

Listed and assessed listed medicines: Application and submission user guide

Listed and assessed listed medicines: Application and submission user guide

Guidance updated

Therapeutic Goods Administration - Australia