Պենիցիլին-Գ

main_info

  • trade_name:
  • Պենիցիլին-Գ ՌՍ
  • dosage:
  • 1000000ՄՄ(50) ապակե սրվակ
  • pharmaceutical_form:
  • դեղափոշի ներարկման լուծույթի
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Պենիցիլին-Գ ՌՍ
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

3-4-2019

Rijk en banken vereenvoudigen financiering van kleinschalige woonvormen voor ouderen

Rijk en banken vereenvoudigen financiering van kleinschalige woonvormen voor ouderen

Het moet eenvoudiger worden voor particulieren en sociale ondernemers om kleinschalige woonvormen voor ouderen te financieren. Het Kabinet stelt hiervoor een stimuleringsregeling open. Als onderdeel van de regeling ondertekende minister De Jonge (VWS) vandaag met een aantal banken een overeenkomst waarbij het Rijk garant gaat staan voor delen van de financiering van dergelijke initiatieven.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

2-4-2019

T119 Elf Power Banks recalled due to fire, burn and explosion hazards

T119 Elf Power Banks recalled due to fire, burn and explosion hazards

The power bank's battery can overheat, posing fire, burn and explosion hazards.

Health Canada

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

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

12-4-2019

EU/3/17/1926 (Envigo CRS S.A.)

EU/3/17/1926 (Envigo CRS S.A.)

EU/3/17/1926 (Active substance: Ofranergene obadenovec) - Transfer of orphan designation - Commission Decision (2019)2915 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005420

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1879 (Envigo CRS S.A.)

EU/3/17/1879 (Envigo CRS S.A.)

EU/3/17/1879 (Active substance: Asp-Arg-Val-Tyr-Ile-His-Pro) - Transfer of orphan designation - Commission Decision (2019)2914 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005415

Europe -DG Health and Food Safety

12-4-2019

EU/3/14/1241 (Envigo CRS S.A.)

EU/3/14/1241 (Envigo CRS S.A.)

EU/3/14/1241 (Active substance: Asp-Arg-Val-Tyr-Ile-His-Pro) - Transfer of orphan designation - Commission Decision (2019)2913 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005424

Europe -DG Health and Food Safety

12-4-2019

EU/3/12/1002 (Envigo CRS S.A.)

EU/3/12/1002 (Envigo CRS S.A.)

EU/3/12/1002 (Active substance: Adenovirus-associated vector containing human Fas-c gene) - Transfer of orphan designation - Commission Decision (2019)2911 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005423

Europe -DG Health and Food Safety

12-4-2019

EU/3/12/1093 (Regulis Consulting Europe Limited)

EU/3/12/1093 (Regulis Consulting Europe Limited)

EU/3/12/1093 (Active substance: 1,2:5,6-Dianhydrogalactitol) - Transfer of orphan designation - Commission Decision (2019)2919 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005923

Europe -DG Health and Food Safety

12-4-2019

EU/3/15/1539 (Audentes Therapeutics Netherlands B.V.)

EU/3/15/1539 (Audentes Therapeutics Netherlands B.V.)

EU/3/15/1539 (Active substance: Adeno-associated viral vector serotype 8 containing the human MTM1 gene) - Transfer of orphan designation - Commission Decision (2019)2918 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004956

Europe -DG Health and Food Safety

12-4-2019

EU/3/15/1588 (Regulis Consulting Europe Limited)

EU/3/15/1588 (Regulis Consulting Europe Limited)

EU/3/15/1588 (Active substance: (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) - Transfer of orphan designation - Commission Decision (2019)2917 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005712

Europe -DG Health and Food Safety

12-4-2019

EU/3/07/452 (Regulis Consulting Europe Limited)

EU/3/07/452 (Regulis Consulting Europe Limited)

EU/3/07/452 (Active substance: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H -1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea) - Transfer of orphan designation - Commission Decision (2019)2916 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005708

Europe -DG Health and Food Safety

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

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/3/16/1628 (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/3/14/1284 (Basilea Pharmaceutica Deutschland GmbH)

EU/3/14/1284 (Basilea Pharmaceutica Deutschland GmbH)

EU/3/14/1284 (Active substance: Isavuconazonium sulfate) - Transfer of orphan designation - Commission Decision (2019)2670 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004336

Europe -DG Health and Food Safety

3-4-2019

EU/3/14/1276 (Basilea Pharmaceutica Deutschland GmbH)

EU/3/14/1276 (Basilea Pharmaceutica Deutschland GmbH)

EU/3/14/1276 (Active substance: Isavuconazonium sulfate) - Transfer of orphan designation - Commission Decision (2019)2669 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004334

Europe -DG Health and Food Safety

3-4-2019

EU/3/09/641 (Atlantic Healthcare Europe B.V.)

EU/3/09/641 (Atlantic Healthcare Europe B.V.)

EU/3/09/641 (Active substance: Alicaforsen) - Transfer of orphan designation - Commission Decision (2019)2671 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004618

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1721 (Araim Pharmaceuticals Europe Limited)

EU/3/16/1721 (Araim Pharmaceuticals Europe Limited)

EU/3/16/1721 (Active substance: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser) - Transfer of orphan designation - Commission Decision (2019)2676 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005497

Europe -DG Health and Food Safety

3-4-2019

EU/3/13/1191 (Araim Pharmaceuticals Europe Limited)

EU/3/13/1191 (Araim Pharmaceuticals Europe Limited)

EU/3/13/1191 (Active substance: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser) - Transfer of orphan designation - Commission Decision (2019)2675 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004909

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Active substance: Human/murine chimeric monoclonal antibody against endoglin) - Transfer of orphan designation - Commission Decision (2019)2677 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004633

Europe -DG Health and Food Safety

2-4-2019

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Active substance: methotrexate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2624 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3756/T/7

Europe -DG Health and Food Safety

2-4-2019

EU/3/06/374 (Therakos Europe Limited)

EU/3/06/374 (Therakos Europe Limited)

EU/3/06/374 (Active substance: Methoxsalen) - Transfer of orphan designation - Commission Decision (2019)2420 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004676

Europe -DG Health and Food Safety

2-4-2019

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Transfer of orphan designation - Commission Decision (2019)2411 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004889

Europe -DG Health and Food Safety

2-4-2019

EU/3/17/1868 (Diamond ROC EOOD)

EU/3/17/1868 (Diamond ROC EOOD)

EU/3/17/1868 (Active substance: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine) - Transfer of orphan designation - Commission Decision (2019)2407 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004677

Europe -DG Health and Food Safety

1-4-2019

Sialanar (Proveca Pharma Limited)

Sialanar (Proveca Pharma Limited)

Sialanar (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2593 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3883/T/09

Europe -DG Health and Food Safety

1-4-2019

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Transfer of orphan designation - Commission Decision (2019)2423 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004425

Europe -DG Health and Food Safety

1-4-2019

EU/3/13/1232 (Amicus Therapeutics Europe Limited)

EU/3/13/1232 (Amicus Therapeutics Europe Limited)

EU/3/13/1232 (Active substance: Allantoin) - Transfer of orphan designation - Commission Decision (2019)2422 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004625

Europe -DG Health and Food Safety

1-4-2019

EU/3/06/368 (Amicus Therapeutics Europe Limited)

EU/3/06/368 (Amicus Therapeutics Europe Limited)

EU/3/06/368 (Active substance: 1-deoxygalactonojirimycin hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2421 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004426

Europe -DG Health and Food Safety

1-4-2019

EU/3/14/1379 (Maxia Strategies-Europe Limited)

EU/3/14/1379 (Maxia Strategies-Europe Limited)

EU/3/14/1379 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2410 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004589

Europe -DG Health and Food Safety

1-4-2019

Galafold (Amicus Therapeutics Europe Limited)

Galafold (Amicus Therapeutics Europe Limited)

Galafold (Active substance: migalastat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2580 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004059/T/0020

Europe -DG Health and Food Safety

29-3-2019

Nerlynx (Puma Biotechnology B.V.)

Nerlynx (Puma Biotechnology B.V.)

Nerlynx (Active substance: neratinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2579 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4030/T/01

Europe -DG Health and Food Safety

29-3-2019

EU/3/18/2102 (TherAchon SAS)

EU/3/18/2102 (TherAchon SAS)

EU/3/18/2102 (Active substance: Apraglutide) - Transfer of orphan designation - Commission Decision (2019)2415 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004473

Europe -DG Health and Food Safety

29-3-2019

EU/3/14/1280 (Orchard Therapeutics (Europe) Limited)

EU/3/14/1280 (Orchard Therapeutics (Europe) Limited)

EU/3/14/1280 (Active substance: Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene) - Transfer of orphan designation - Commission Decision (2019)2432 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003985

Europe -DG Health and Food Safety

29-3-2019

EU/3/13/1134 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/13/1134 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/13/1134 (Active substance: Autologous CD34+ cells transduced with a lentiviral vector containing the human ADA gene) - Transfer of orphan designation - Commission Decision (2019)2431 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003982

Europe -DG Health and Food Safety

29-3-2019

EU/3/07/446 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/07/446 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/07/446 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA) - Transfer of orphan designation - Commission Decision (2019)2430 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003632

Europe -DG Health and Food Safety