Ipreziv

Withdrawn

This medicine's authorisation has been withdrawn

azilsartan medoxomil

Overview

On 27 October 2014, the European Commission withdrew the marketing authorisation for Ipreziv (azilsartan medoxomil) 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 not to market the product in the EU for commercial reasons. Ipreziv was granted marketing authorisation in the EU on 07 December 2011 for the treatment of essential hypertension in adults. It belongs to an established class of medicines in the treatment of hypertension. 

The product had not been marketed in the EU from the time of the marketing authorisation on 07 December 2011. Ipreziv was a duplicate application to Edarbi, which is marketed in the EU. The marketing authorisation holder will maintain the marketing authorisation for Edarbi. 

The European Public Assessment Report (EPAR) for Ipreziv is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Ipreziv : EPAR - Summary for the public

Reference Number: EMA/807106/2011

Product information

Ipreziv : EPAR - Product Information

Ipreziv : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ipreziv
• Active substance:
  azilsartan medoxomil
• International non-proprietary name (INN) or common name:
  azilsartan medoxomil
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09CA09

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Ipreziv is indicated for the treatment of essential hypertension in adults.

Authorisation details

• EMA product number:
  EMEA/H/C/002517
• Marketing authorisation holder:
  Takeda Pharma A/S

  Dybendal Alle 10; 2630 Taastruup; United Kingdom

• Marketing authorisation issued:
  07/12/2011
• Withdrawal of marketing authorisation:
  27/10/2014
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

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

Ipreziv-H-C-2517-A31-06 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/PRAC/294920/2014

Ipreziv-H-C-2517-A31-06 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendat...

Ipreziv-H-C-2517-PSUV-08 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/538715/2013

CHMP post-authorisation summary of positive opinion for Ipreziv

Adopted Reference Number: EMA/CHMP/569645/2013

Initial marketing authorisation documents

Ipreziv : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Ipreziv

Adopted Reference Number: EMA/CHMP/737200/2011