Iblias

Withdrawn

This medicine's authorisation has been withdrawn

octocog alfa

Overview

On 3 September 2019, the European Commission withdrew the marketing authorisation for Iblias (octocog alfa) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bayer AG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Iblias was granted marketing authorisation in the EU on 18 February 2016 for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2018. 

The European Public Assessment Report (EPAR) for Iblias is updated to indicate that the marketing authorisation is no longer valid.

Iblias : EPAR - Summary for the public

Reference Number: EMEA/H/C/004147

Iblias : EPAR - Risk-management-plan summary

Reference Number: EMA/1562/2016

Product information

Iblias : EPAR - Product Information

Iblias : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Iblias
• Active substance:
  octocog alfa
• International non-proprietary name (INN) or common name:
  octocog alfa
• Therapeutic area (MeSH):
  Hemophilia A
• Anatomical therapeutic chemical (ATC) code:
  B02BD02

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Iblias can be used for all age groups.

Authorisation details

• EMA product number:
  EMEA/H/C/004147
• Marketing authorisation holder:
  Bayer AG

  51368 Leverkusen ; Germany

• Marketing authorisation issued:
  18/02/2016
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Iblias : EPAR - Procedural steps taken and scientific information after authorisation

Iblias-H-C-4147-A31-0002 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/763977/2017

Initial marketing authorisation documents

Iblias : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/71742/2016

CHMP summary of opinion for Iblias

Adopted Reference Number: EMA/CHMP/774757/2015