MEPOLIZUMAB

Main information

  • Trade name:
  • MEPOLIZUMAB Powder for solution for injection 250MG
  • Dosage:
  • 250MG
  • Pharmaceutical form:
  • Powder for solution for injection
  • Administration route:
  • Intravenous use
  • Units in package:
  • 1 Vial
  • Prescription type:
  • on prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEPOLIZUMAB Powder for solution for injection 250MG
    Czech Republic
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Mepolizumab
  • Product summary:
  • MEPOLIZUMAB

Other information

Status

  • Source:
  • SUKL - Státní ústav pro kontrolu léčiv
  • Authorization number:
  • F - specific therapeutic programme
  • Last update:
  • 01-03-2017

27-7-2018

Pending EC decision:  Nucala, mepolizumab, Opinion date: 26-Jul-2018

Pending EC decision: Nucala, mepolizumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

8-6-2018

Orphan designation:  Mepolizumab,  for the: Treatment of Churg-Strauss syndrome

Orphan designation: Mepolizumab, for the: Treatment of Churg-Strauss syndrome

On 12 March 2013, orphan designation (EU/3/13/1116) was granted by the European Commission to Glaxo Group Ltd, United Kingdom, for mepolizumab for the treatment of Churg-Strauss syndrome.

Europe - EMA - European Medicines Agency

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

16-5-2018

EU/3/13/1116 (GlaxoSmithKline Trading Services Limited)

EU/3/13/1116 (GlaxoSmithKline Trading Services Limited)

EU/3/13/1116 (Active substance: Mepolizumab) - Transfer of orphan designation - Commission Decision (2018)3046 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/174/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/04/213 (GlaxoSmithKline Trading Services Limited)

EU/3/04/213 (GlaxoSmithKline Trading Services Limited)

EU/3/04/213 (Active substance: Mepolizumab) - Transfer of orphan designation - Commission Decision (2018)3045 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/027/04/T/02

Europe -DG Health and Food Safety