Glubrava

Withdrawn

This medicine's authorisation has been withdrawn

pioglitazone / metformin

Overview

On 24 May 2022 the European Commission withdrew the marketing authorisation for Glubrava (pioglitazone / metformin hydrochloride) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Pharma A/S, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Glubrava was granted marketing authorisation in the EU on 11 December 2007 for treatment of type 2 diabetes mellitus. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2012. It was then granted unlimited validity in 2017. The product had not been marketed in the EU since 2021. 

Glubrava is identical to Competact, which is authorised in the EU to treat type 2 diabetes mellitus in adult patients. 

The European Public Assessment Report (EPAR) for Glubrava is updated to indicate that the marketing authorisation is no longer valid.

Glubrava : EPAR - Summary for the public

Glubrava : EPAR - Risk-management-plan summary

Product information

Glubrava : EPAR - Product Information

Glubrava : EPAR - All Authorised presentations

Glubrava : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Glubrava
• Active substance:
  • metformin hydrochloride
  • pioglitazone hydrochloride
• International non-proprietary name (INN) or common name:
  • pioglitazone
  • metformin
• Therapeutic area (MeSH):
  Diabetes Mellitus, Type 2
• Anatomical therapeutic chemical (ATC) code:
  A10BD05

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.

After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

Authorisation details

• EMA product number:
  EMEA/H/C/000893
• Marketing authorisation holder:
  Takeda Pharma A/S

  Delta Park 45; 2665 Vallensbaek Strand; Denmark

• Marketing authorisation issued:
  11/12/2007
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

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

Glubrava-H-C-PSUSA-00002417-201807 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/241766/2019

Glubrava : EPAR - Scientific Conclusion

Glubrava-H-C-893-PSUV-0029 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/566874/2013

Glubrava-H-C-893-A20-0015 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/CHMP/940059/2011

Initial marketing authorisation documents

Glubrava-H-A31-1432 : EPAR - Public assessment report - Article 31

Glubrava : EPAR - Procedural steps taken before authorisation

Glubrava : EPAR - Scientific Discussion