10%

main_info

  • trade_name:
  • 10% Գլյուկոզի լուծույթ ներարկման համար
  • dosage:
  • 100մգ/մլ100մլ, 200մլ, 250մլ, 500մլ, 1000մլ, 2000մլ և 3000մլ պլաստիկե փաթ
  • pharmaceutical_form:
  • լուծույթ կաթիլաներարկման
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • 10% Գլյուկոզի լուծույթ ներարկման համար
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

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

8-4-2019

Brian Richardson DBA “In Tha Pink” Issues Voluntary Nationwide Recall of Kopi Jantan Tradisional Natural Herbs Coffee Due to Presence of Undeclared Sildenafil and Tadalafil

Brian Richardson DBA “In Tha Pink” Issues Voluntary Nationwide Recall of Kopi Jantan Tradisional Natural Herbs Coffee Due to Presence of Undeclared Sildenafil and Tadalafil

Brian Richardson DBA “In Tha Pink”, is voluntarily recalling lots with the expiration of October 13, 2020 (13/10/2020) of ground Kopi Jantan Tradisional Natural Herbs Coffee to the consumer level. FDA analysis has found the product to be tainted with Sildenafil and Tadalafil

FDA - U.S. Food and Drug Administration

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

21-3-2019

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips

The recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes which may have affected 660 bags of 10-ounce Original Potato Chips.

FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Staatssecretaris Blokhuis: komende jaren krijgen alle dak- en thuisloze jongeren hulp

Staatssecretaris Blokhuis: komende jaren krijgen alle dak- en thuisloze jongeren hulp

In een welvarend land als Nederland zou geen enkele jongere op straat moeten leven of noodgedwongen steeds op wisselende plekken verblijven. Met die ambitie lanceert staatssecretaris Paul Blokhuis (VWS) vandaag het Actieprogramma Dak- en Thuisloze Jongeren. De inspanningen moeten ertoe leiden dat alle ruim 10.000 dak- en thuisloze jongeren (tussen de 18 en 27 jaar) de komende jaren geholpen worden naar een zo zelfstandig mogelijk bestaan met een eigen thuis. En dat ook in de toekomst een nieuwe instroom ...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

26-2-2019

UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist

UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist

Utz Quality Foods, LLC., is voluntarily recalling a specific expiration date code of Bachman 10 oz Twist Pretzel packages due to undeclared milk. This recall was initiated after reviewing production records which identified a small number of packages were mislabeled.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

21-2-2019


Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Europe - EMA - European Medicines Agency

15-2-2019

Toegang tot Wet langdurige zorg ook voor mensen met een psychische stoornis

Toegang tot Wet langdurige zorg ook voor mensen met een psychische stoornis

Mensen die hun leven lang intensieve geestelijke gezondheidszorg (GGZ) nodig hebben, kunnen vanaf 2021 toegang krijgen tot de Wet langdurige zorg (Wlz). Het gaat hierbij naar verwachting om 10.000 cliënten die permanent toezicht of 24 uur per dag zorg in de nabijheid nodig hebben en nu zorg en ondersteuning krijgen vanuit de Wet maatschappelijk ondersteuning of de Zorgverzekeringswet. De ministerraad heeft op voorstel van staatssecretaris Blokhuis van Volksgezondheid, Welzijn en Sport ingestemd met toeze...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-2-2019

Health Canada will be updating its safety review of breast implants

Health Canada will be updating its safety review of breast implants

OTTAWA - Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased...

Health Canada

9-2-2019

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

BIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

26-1-2019

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Published on: Fri, 25 Jan 2019 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylc...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-4-2019


Orphan designation: Ofranergene obadenovec, Treatment of ovarian cancer, 16/10/2017, Positive

Orphan designation: Ofranergene obadenovec, Treatment of ovarian cancer, 16/10/2017, Positive

Orphan designation: Ofranergene obadenovec, Treatment of ovarian cancer, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene, Treatment of X-linked myotubular myopathy, 10/08/2015, Positive

Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene, Treatment of X-linked myotubular myopathy, 10/08/2015, Positive

Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene, Treatment of X-linked myotubular myopathy, 10/08/2015, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Cannabidiol, Treatment of West syndrome, 16/10/2017, Positive

Orphan designation: Cannabidiol, Treatment of West syndrome, 16/10/2017, Positive

Orphan designation: Cannabidiol, Treatment of West syndrome, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Cannabidivarin, Treatment of Rett syndrome, 16/10/2017, Positive

Orphan designation: Cannabidivarin, Treatment of Rett syndrome, 16/10/2017, Positive

Orphan designation: Cannabidivarin, Treatment of Rett syndrome, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Cannabidiol, Treatment of Dravet syndrome, 15/10/2014, Positive

Orphan designation: Cannabidiol, Treatment of Dravet syndrome, 15/10/2014, Positive

Orphan designation: Cannabidiol, Treatment of Dravet syndrome, 15/10/2014, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Raxibacumab, Treatment of inhalation anthrax disease, 15/10/2014, Positive

Orphan designation: Raxibacumab, Treatment of inhalation anthrax disease, 15/10/2014, Positive

Orphan designation: Raxibacumab, Treatment of inhalation anthrax disease, 15/10/2014, Positive

Europe - EMA - European Medicines Agency

16-4-2019

The companies will have 10 days to submit their plans to withdraw these products from the market to the #FDA.  #MedicalDevice

The companies will have 10 days to submit their plans to withdraw these products from the market to the #FDA. #MedicalDevice

The companies will have 10 days to submit their plans to withdraw these products from the market to the #FDA. #MedicalDevice

FDA - U.S. Food and Drug Administration

15-4-2019

EU/3/10/780 (Mundipharma Corporation (Ireland) Limited)

EU/3/10/780 (Mundipharma Corporation (Ireland) Limited)

EU/3/10/780 (Active substance: Forodesine) - Transfer of orphan designation - Commission Decision (2019)2967 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004896

Europe -DG Health and Food Safety

12-4-2019


Orphan designation: Entinostat, Treatment of Hodgkin's lymphoma, 10/06/2010, Positive

Orphan designation: Entinostat, Treatment of Hodgkin's lymphoma, 10/06/2010, Positive

Orphan designation: Entinostat, Treatment of Hodgkin's lymphoma, 10/06/2010, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid, Treatment of Rett syndrome, 10/08/2015, Positive

Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid, Treatment of Rett syndrome, 10/08/2015, Positive

Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid, Treatment of Rett syndrome, 10/08/2015, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: cholest-4-en-3-one, oxime, Treatment of 5q spinal muscular atrophy, 10/03/2005, Withdrawn

Orphan designation: cholest-4-en-3-one, oxime, Treatment of 5q spinal muscular atrophy, 10/03/2005, Withdrawn

Orphan designation: cholest-4-en-3-one, oxime, Treatment of 5q spinal muscular atrophy, 10/03/2005, Withdrawn

Europe - EMA - European Medicines Agency

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

M-M-RVAXPRO (MSD VACCINS)

M-M-RVAXPRO (MSD VACCINS)

M-M-RVAXPRO (Active substance: Measles, Mumps and Rubella Vaccine (Live)) - PSUSA - Modification - Commission Decision (2019)2812 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00001937/201805

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

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

10-4-2019

Capecitabine medac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Capecitabine medac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Capecitabine medac (Active substance: capecitabine) - PSUSA - Modification - Commission Decision (2019)2817 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00000531/201804

Europe -DG Health and Food Safety

5-4-2019


Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Europe - EMA - European Medicines Agency

3-4-2019

EU/3/17/1842 (EUDRAC GmbH)

EU/3/17/1842 (EUDRAC GmbH)

EU/3/17/1842 (Active substance: Recombinant human club cell 10 KDa protein) - Transfer of orphan designation - Commission Decision (2019)2668 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004449

Europe -DG Health and Food Safety

28-3-2019

EU/3/10/804 (Pharma Gateway AB)

EU/3/10/804 (Pharma Gateway AB)

EU/3/10/804 (Active substance: Methylthioninium) - Transfer of orphan designation - Commission Decision (2019)2416 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005100

Europe -DG Health and Food Safety

28-3-2019

EU/3/10/807 (Pharma Gateway AB)

EU/3/10/807 (Pharma Gateway AB)

EU/3/10/807 (Active substance: Methylthioninium) - Transfer of orphan designation - Commission Decision (2019)2419 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004926

Europe -DG Health and Food Safety

28-3-2019

EU/3/10/806 (Pharma Gateway AB)

EU/3/10/806 (Pharma Gateway AB)

EU/3/10/806 (Active substance: Methylthioninium) - Transfer of orphan designation - Commission Decision (2019)2418 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005102

Europe -DG Health and Food Safety

28-3-2019

EU/3/10/805 (Pharma Gateway AB)

EU/3/10/805 (Pharma Gateway AB)

EU/3/10/805 (Active substance: Methylthioninium) - Transfer of orphan designation - Commission Decision (2019)2417 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005087

Europe -DG Health and Food Safety

27-3-2019

Omidria (Omeros Ireland Limited)

Omidria (Omeros Ireland Limited)

Omidria (Active substance: phenylephrine / ketorolac) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2379 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3702/T/10

Europe -DG Health and Food Safety

27-3-2019

EU/3/10/753 (Intercept Pharma International Limited)

EU/3/10/753 (Intercept Pharma International Limited)

EU/3/10/753 (Active substance: 6alpha-ethyl-chenodeoxycholic acid) - Transfer of orphan designation - Commission Decision (2019)2408 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002873

Europe -DG Health and Food Safety

19-3-2019

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Active substance: Lomitapide) - Transfer of orphan designation - Commission Decision (2019)2152 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004233

Europe -DG Health and Food Safety

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

14-3-2019


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (Active substance: dinutuximab beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2061 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3918/T/10

Europe -DG Health and Food Safety

7-3-2019

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1913 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4024/T/10

Europe -DG Health and Food Safety

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

25-2-2019

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Active substance: Entinostat) - Transfer of orphan designation - Commission Decision (2019)1631 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004131

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Active substance: Synthetic double-stranded short interfering RNA oligonucleotide directed against proopiomelanocortin) - Transfer of orphan designation - Commission Decision (2019)1360 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003061

Europe -DG Health and Food Safety

13-2-2019


Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

28-1-2019


Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Europe - EMA - European Medicines Agency