FLIXCELI

Main information

  • Trade name:
  • FLIXCELI infliximab (rmc) 100mg Powder for Injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLIXCELI infliximab (rmc) 100mg Powder for Injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217063
  • Last update:
  • 09-10-2017

1-8-2018

Inflectra (Pfizer Europe MA EEIG)

Inflectra (Pfizer Europe MA EEIG)

Inflectra (Active substance: Infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5206 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2778/T/64

Europe -DG Health and Food Safety

23-5-2018

Zessly (Sandoz GmbH)

Zessly (Sandoz GmbH)

Zessly (Active substance: infliximab) - Centralised - Authorisation - Commission Decision (2018)3215 of Wed, 23 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4647

Europe -DG Health and Food Safety

16-5-2018

Inflectra (Hospira UK Limited)

Inflectra (Hospira UK Limited)

Inflectra (Active substance: Infliximab) - Centralised - Yearly update - Commission Decision (2018)3054 of Wed, 16 May 2018

Europe -DG Health and Food Safety

15-5-2018

Flixabi (Samsung Bioepis UK Limited)

Flixabi (Samsung Bioepis UK Limited)

Flixabi (Active substance: infliximab) - Centralised - Yearly update - Commission Decision (2018)3056 of Tue, 15 May 2018

Europe -DG Health and Food Safety

3-5-2018

Remsima (Celltrion Healthcare Hungary Kft.)

Remsima (Celltrion Healthcare Hungary Kft.)

Remsima (Active substance: Infliximab) - Centralised - Yearly update - Commission Decision (2018)2769 of Thu, 03 May 2018

Europe -DG Health and Food Safety

23-3-2018

Pending EC decision:  Zessly, infliximab, Opinion date: 22-Mar-2018

Pending EC decision: Zessly, infliximab, Opinion date: 22-Mar-2018

Europe - EMA - European Medicines Agency