Պիրօքսիկամ-Ակրի

main_info

  • trade_name:
  • Պիրօքսիկամ-Ակրի
  • dosage:
  • 20մգ(20/2x10/) բլիստերում
  • pharmaceutical_form:
  • դեղապատիճներ
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Պիրօքսիկամ-Ակրի
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

no_alert

23-4-2019


Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of epidermolysis bullosa, 20/06/2017, Positive

Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of epidermolysis bullosa, 20/06/2017, Positive

Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of epidermolysis bullosa, 20/06/2017, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-β-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one (etoposide toniri

Orphan designation: (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-β-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one (etoposide toniri

Orphan designation: (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-β-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one (etoposide toniribate), Treatment of biliary tract cancer, 04/06/2014, Positive

Europe - EMA - European Medicines Agency

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: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of Duchenne muscular dystrophy, 19/02/2014, Positive

Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of Duchenne muscular dystrophy, 19/02/2014, Positive

Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of Duchenne muscular dystrophy, 19/02/2014, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Adenovirus-associated vector containing human Fas-c gene (ofranergene obadenovec), Treatment of glioma, 06/06/2012, Positive

Orphan designation: Adenovirus-associated vector containing human Fas-c gene (ofranergene obadenovec), Treatment of glioma, 06/06/2012, Positive

Orphan designation: Adenovirus-associated vector containing human Fas-c gene (ofranergene obadenovec), Treatment of glioma, 06/06/2012, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Cannabidivarin, Treatment of fragile X syndrome, 22/02/2018, Positive

Orphan designation: Cannabidivarin, Treatment of fragile X syndrome, 22/02/2018, Positive

Orphan designation: Cannabidivarin, Treatment of fragile X syndrome, 22/02/2018, 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 tuberous sclerosis, 17/01/2018, Positive

Orphan designation: Cannabidiol, Treatment of tuberous sclerosis, 17/01/2018, Positive

Orphan designation: Cannabidiol, Treatment of tuberous sclerosis, 17/01/2018, 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: Cannabidiol, Treatment of Lennox-Gastaut syndrome, 20/03/2017, Positive

Orphan designation: Cannabidiol, Treatment of Lennox-Gastaut syndrome, 20/03/2017, Positive

Orphan designation: Cannabidiol, Treatment of Lennox-Gastaut syndrome, 20/03/2017, 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: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant, Treatment glioma, 17/02/2016, Positive

Orphan designation: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant, Treatment glioma, 17/02/2016, Positive

Orphan designation: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant, Treatment glioma, 17/02/2016, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: 1,2:5,6-Dianhydrogalactitol, Treatment of glioma, 24/01/2013, Positive

Orphan designation: 1,2:5,6-Dianhydrogalactitol, Treatment of glioma, 24/01/2013, Positive

Orphan designation: 1,2:5,6-Dianhydrogalactitol, Treatment of glioma, 24/01/2013, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea (netazepide), Treatment of gastric carcinoid, 14/06/2007, Positive

Orphan designation: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea (netazepide), Treatment of gastric carcinoid, 14/06/2007, Positive

Orphan designation: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea (netazepide), Treatment of gastric carcinoid, 14/06/2007, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide), Treatment of gastro-entero-pancreatic neuroendocrine tumours, 14/12/2015, Pos

Orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide), Treatment of gastro-entero-pancreatic neuroendocrine tumours, 14/12/2015, Pos

Orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide), Treatment of gastro-entero-pancreatic neuroendocrine tumours, 14/12/2015, 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

15-4-2019

EU/3/14/1270 (Mundipharma Corporation (Ireland) Limited)

EU/3/14/1270 (Mundipharma Corporation (Ireland) Limited)

EU/3/14/1270 (Active substance: (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-beta-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one) - Transfer of orphan designation - Commission Decision (2019)2968 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005740

Europe -DG Health and Food Safety

15-4-2019

EU/3/18/2130 (Unither Therapeutik GmbH)

EU/3/18/2130 (Unither Therapeutik GmbH)

EU/3/18/2130 (Active substance: Ralinepag) - Transfer of orphan designation - Commission Decision (2019)2969 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005929

Europe -DG Health and Food Safety

15-4-2019

EU/3/15/1491 (Cochamo Pharma Limited)

EU/3/15/1491 (Cochamo Pharma Limited)

EU/3/15/1491 (Active substance: Adeno-associated viral vector serotype 9 containing the human HGSNAT gene) - Transfer of orphan designation - Commission Decision (2019)2970 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004475

Europe -DG Health and Food Safety

15-4-2019

EU/3/14/1352 (Emergent Netherlands B.V.)

EU/3/14/1352 (Emergent Netherlands B.V.)

EU/3/14/1352 (Active substance: Raxibacumab) - Transfer of orphan designation - Commission Decision (2019)2971 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005567

Europe -DG Health and Food Safety

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

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

15-4-2019


Orphan designation: Sodium nitrite, Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive

Orphan designation: Sodium nitrite, Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive

Orphan designation: Sodium nitrite, Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive

Europe - EMA - European Medicines Agency

15-4-2019


Orphan designation: Sodium thiosulfate, Treatment for calciphylaxis, 15/01/2015, Positive

Orphan designation: Sodium thiosulfate, Treatment for calciphylaxis, 15/01/2015, Positive

Orphan designation: Sodium thiosulfate, Treatment for calciphylaxis, 15/01/2015, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2, Treatment of shiga-toxin-producing bacterial infection, 26/08/2005, Positive

Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2, Treatment of shiga-toxin-producing bacterial infection, 26/08/2005, Positive

Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2, Treatment of shiga-toxin-producing bacterial infection, 26/08/2005, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Adeno-associated viral vector serotype 2 containing the human REP1 gene, Treatment of choroideraemia, 04/07/2014, Positive

Orphan designation: Adeno-associated viral vector serotype 2 containing the human REP1 gene, Treatment of choroideraemia, 04/07/2014, Positive

Orphan designation: Adeno-associated viral vector serotype 2 containing the human REP1 gene, Treatment of choroideraemia, 04/07/2014, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-

Orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-

Orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly, Treatment of acute myeloid leukaemia, 28/04/2016, Positive

Europe - EMA - European Medicines Agency

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: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of meningioma, 06/06/2012, Positive

Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of meningioma, 06/06/2012, Positive

Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of meningioma, 06/06/2012, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of neurofibromatosis type 2, 26/04/2012, Positive

Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of neurofibromatosis type 2, 26/04/2012, Positive

Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of neurofibromatosis type 2, 26/04/2012, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of schwannoma, 06/06/2012, Positive

Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of schwannoma, 06/06/2012, Positive

Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of schwannoma, 06/06/2012, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid, Treatment of fragile X syndrome, 28/07/2015, Positive

Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid, Treatment of fragile X syndrome, 28/07/2015, Positive

Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid, Treatment of fragile X syndrome, 28/07/2015, 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 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

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: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, 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

12-4-2019


Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/0

Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/0

Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/05/2015, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Venetoclax, Treatment of acute myeloid leukaemia, 17/02/2016, Withdrawn

Orphan designation: Venetoclax, Treatment of acute myeloid leukaemia, 17/02/2016, Withdrawn

Orphan designation: Venetoclax, Treatment of acute myeloid leukaemia, 17/02/2016, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Nitric oxide, Treatment of cystic fibrosis, 24/04/2015, Withdrawn

Orphan designation: Nitric oxide, Treatment of cystic fibrosis, 24/04/2015, Withdrawn

Orphan designation: Nitric oxide, Treatment of cystic fibrosis, 24/04/2015, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019

EU/3/18/2038 (PPD Bulgaria EOOD)

EU/3/18/2038 (PPD Bulgaria EOOD)

EU/3/18/2038 (Active substance: Palovarotene) - Transfer of orphan designation - Commission Decision (2019)2940 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005020

Europe -DG Health and Food Safety

12-4-2019

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Active substance: Recombinant adeno-associated viral vector containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)2934 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005876

Europe -DG Health and Food Safety

12-4-2019

EU/3/15/1556 (Diamond ROC EOOD)

EU/3/15/1556 (Diamond ROC EOOD)

EU/3/15/1556 (Active substance: Recombinant adeno-associated viral vector containing human CNGA3 gene) - Transfer of orphan designation - Commission Decision (2019)2933 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005873

Europe -DG Health and Food Safety

12-4-2019

EU/3/13/1107 (Diamond ROC EOOD)

EU/3/13/1107 (Diamond ROC EOOD)

EU/3/13/1107 (Active substance: Recombinant adeno-associated viral vector containing the human retinoschisin gene) - Transfer of orphan designation - Commission Decision (2019)2932 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005875

Europe -DG Health and Food Safety

12-4-2019

EU/3/13/1099 (Diamond ROC EOOD)

EU/3/13/1099 (Diamond ROC EOOD)

EU/3/13/1099 (Active substance: Recombinant adeno-associated viral vector containing the human CNGB3 gene) - Transfer of orphan designation - Commission Decision (2019)2931 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005874

Europe -DG Health and Food Safety

12-4-2019

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Active substance: Recombinant adeno-associated viral vector containing human alpha-1 antitrypsin gene) - Transfer of orphan designation - Commission Decision (2019)2930 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005871

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2124 (IntraBio Ireland Ltd)

EU/3/18/2124 (IntraBio Ireland Ltd)

EU/3/18/2124 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2939 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005404

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2059 (IntraBio Ireland Ltd)

EU/3/18/2059 (IntraBio Ireland Ltd)

EU/3/18/2059 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2938 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005399

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1949 (IntraBio Ireland Ltd)

EU/3/17/1949 (IntraBio Ireland Ltd)

EU/3/17/1949 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2936 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005385

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1878 (IntraBio Ireland Ltd)

EU/3/17/1878 (IntraBio Ireland Ltd)

EU/3/17/1878 (Active substance: Ursodeoxycholic acid) - Transfer of orphan designation - Commission Decision (2019)2937 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005394

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1848 (IntraBio Ireland Ltd)

EU/3/17/1848 (IntraBio Ireland Ltd)

EU/3/17/1848 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2935 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005357

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/1977 (GW Pharma (International) B.V)

EU/3/18/1977 (GW Pharma (International) B.V)

EU/3/18/1977 (Active substance: Cannabidivarin) - Transfer of orphan designation - Commission Decision (2019)2929 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004768

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1959 (GW Pharma (International) B.V)

EU/3/17/1959 (GW Pharma (International) B.V)

EU/3/17/1959 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2925 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004767

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1921 (GW Pharma (International) B.V)

EU/3/17/1921 (GW Pharma (International) B.V)

EU/3/17/1921 (Active substance: Cannabidivarin) - Transfer of orphan designation - Commission Decision (2019)2928 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004766

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1920 (GW Pharma (International) B.V)

EU/3/17/1920 (GW Pharma (International) B.V)

EU/3/17/1920 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2927 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004765

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1855 (GW Pharma (International) B.V)

EU/3/17/1855 (GW Pharma (International) B.V)

EU/3/17/1855 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2926 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004607

Europe -DG Health and Food Safety

12-4-2019

EU/3/16/1621 (GW Pharma (International) B.V)

EU/3/16/1621 (GW Pharma (International) B.V)

EU/3/16/1621 (Active substance: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant) - Transfer of orphan designation - Commission Decision (2019)2924 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004763

Europe -DG Health and Food Safety

12-4-2019

EU/3/14/1339 (GW Pharma (International) B.V)

EU/3/14/1339 (GW Pharma (International) B.V)

EU/3/14/1339 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2923 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004708

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision (2019)2922 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005194

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2035 (JVM Europe B.V.)

EU/3/18/2035 (JVM Europe B.V.)

EU/3/18/2035 (Active substance: Efpegsomatropin) - Transfer of orphan designation - Commission Decision (2019)2921 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005050

Europe -DG Health and Food Safety