Պիրօքսիկամ-Ակրի

main_info

  • trade_name:
  • Պիրօքսիկամ-Ակրի
  • dosage:
  • 10մգ(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

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

12-4-2019

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (Active substance: Glucagon analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision 2920 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005277

Europe -DG Health and Food Safety

9-4-2019


Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of CHARGE syndrome, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of CHARGE syndrome, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of CHARGE syndrome, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of DiGeorge syndrome, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of DiGeorge syndrome, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of DiGeorge syndrome, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: losartan, Treatment of epidermolysis bullosa, 26/02/2019, Positive

Orphan designation: losartan, Treatment of epidermolysis bullosa, 26/02/2019, Positive

Orphan designation: losartan, Treatment of epidermolysis bullosa, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, Treatment of infantile neuroaxonal dystrophy, 26/02/2019, Positive

Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, Treatment of infantile neuroaxonal dystrophy, 26/02/2019, Positive

Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, Treatment of infantile neuroaxonal dystrophy, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Risdiplam, Treatment of spinal muscular atrophy, 26/02/2019, Positive

Orphan designation: Risdiplam, Treatment of spinal muscular atrophy, 26/02/2019, Positive

Orphan designation: Risdiplam, Treatment of spinal muscular atrophy, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

8-4-2019


Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine, Treatment of fragile X syndrome, 20/04/2017, Positive

Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine, Treatment of fragile X syndrome, 20/04/2017, Positive

Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine, Treatment of fragile X syndrome, 20/04/2017, Positive

Europe - EMA - European Medicines Agency

8-4-2019


Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, Positive

Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, Positive

Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, Positive

Europe - EMA - European Medicines Agency

8-4-2019


Orphan designation: Sirolimus, Treatment of tuberous sclerosis, 23/08/2017, Positive

Orphan designation: Sirolimus, Treatment of tuberous sclerosis, 23/08/2017, Positive

Orphan designation: Sirolimus, Treatment of tuberous sclerosis, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

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

3-4-2019

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Active substance: Codon-optimised human cystic fibrosis transmembrane conductance regulator messenger ribonucleic acid complexed with lipid-based nanoparticles) - Orphan designation - Commission Decision (2019)2666 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002333

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2146 (Taiho Pharma Europe Limited)

EU/3/19/2146 (Taiho Pharma Europe Limited)

EU/3/19/2146 (Active substance: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one) - Orphan designation - Commission Decision (2019)2662 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002457

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2673 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003473

Europe -DG Health and Food Safety

3-4-2019

EU/3/14/1378 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/14/1378 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/14/1378 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2672 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003420

Europe -DG Health and Food Safety

3-4-2019

EU/3/15/1520 (GW Pharma (International) B.V)

EU/3/15/1520 (GW Pharma (International) B.V)

EU/3/15/1520 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2674 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004600

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2151 (Voisin Consulting S.A.R.L.)

EU/3/19/2151 (Voisin Consulting S.A.R.L.)

EU/3/19/2151 (Active substance: Marzeptacog alfa (activated)) - Orphan designation - Commission Decision (2019)2667 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002304

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2149 (Brainvectis)

EU/3/19/2149 (Brainvectis)

EU/3/19/2149 (Active substance: Adeno-associated viral vector serotype rh10 containing the human cholesterol 24-hydroxylase gene) - Orphan designation - Commission Decision (2019)2665 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002264

Europe -DG Health and Food Safety