Overview

The marketing authorisation for Ipreziv has been withdrawn at the request of the marketing authorisation holder.

Ipreziv : EPAR - Summary for the public

Reference Number: EMA/807106/2011

English (EN) (520.34 KB - PDF)

First published: Last updated:
View

български (BG) (620.92 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

español (ES) (521.15 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

čeština (CS) (588.1 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

dansk (DA) (522.61 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Deutsch (DE) (523.5 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

eesti keel (ET) (521.06 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

ελληνικά (EL) (626.33 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

français (FR) (584.81 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

italiano (IT) (524.56 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

latviešu valoda (LV) (592.4 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

lietuvių kalba (LT) (1.03 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

magyar (HU) (641.67 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Malti (MT) (587.66 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Nederlands (NL) (521.58 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

polski (PL) (589.01 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

português (PT) (537.62 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

română (RO) (548.34 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

slovenčina (SK) (585.36 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

slovenščina (SL) (582.95 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Suomi (FI) (514.89 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

svenska (SV) (521.93 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Product information

Ipreziv : EPAR - Product Information

English (EN) (1023.63 KB - PDF)

First published: Last updated:
View

български (BG) (2.36 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

español (ES) (1.03 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

čeština (CS) (1.92 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

dansk (DA) (1.13 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Deutsch (DE) (1.3 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

eesti keel (ET) (1.03 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

ελληνικά (EL) (2.4 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

français (FR) (1.05 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

hrvatski (HR) (405.04 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

íslenska (IS) (1.19 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

italiano (IT) (1.09 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

latviešu valoda (LV) (1.99 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

lietuvių kalba (LT) (2.79 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

magyar (HU) (1.91 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Malti (MT) (2.03 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Nederlands (NL) (1.11 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

norsk (NO) (1.13 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

polski (PL) (1.95 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

português (PT) (1.03 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

română (RO) (1.3 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

slovenčina (SK) (1.89 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

slovenščina (SL) (1.8 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Suomi (FI) (1.11 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

svenska (SV) (1.03 MB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Latest procedure affecting product information: A31/0006

27/10/2014

Globe icon

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Ipreziv : EPAR - All Authorised presentations

English (EN) (469.98 KB - PDF)

First published: Last updated:
View

български (BG) (511.36 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

español (ES) (477.2 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

čeština (CS) (493.96 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

dansk (DA) (469.53 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Deutsch (DE) (476.77 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

eesti keel (ET) (476.07 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

ελληνικά (EL) (513.77 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

français (FR) (477.06 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

íslenska (IS) (474.64 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

italiano (IT) (471.38 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

latviešu valoda (LV) (500.54 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

lietuvių kalba (LT) (958.84 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

magyar (HU) (494.58 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Malti (MT) (491.65 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Nederlands (NL) (475.71 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

norsk (NO) (468 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

polski (PL) (493.06 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

português (PT) (473.56 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

română (RO) (485.97 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

slovenčina (SK) (494.97 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

slovenščina (SL) (483.58 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

Suomi (FI) (471.63 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

svenska (SV) (472.58 KB - PDF)

First published: 15/12/2011Last updated: 19/12/2014
View

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
Revision
4

Assessment history

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

English (EN) (579.42 KB - PDF)

First published: Last updated:
View

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

AdoptedReference Number: EMA/PRAC/294920/2014

English (EN) (301.42 KB - PDF)

First published: Last updated:
View

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...

English (EN) (48.81 KB - PDF)

First published: Last updated:
View

български (BG) (87.49 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

español (ES) (50.51 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

čeština (CS) (82.81 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

dansk (DA) (49.01 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

Deutsch (DE) (53.54 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

eesti keel (ET) (50.6 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

ελληνικά (EL) (89.54 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

français (FR) (51.91 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

hrvatski (HR) (80.12 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

italiano (IT) (51.13 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

latviešu valoda (LV) (81.63 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

lietuvių kalba (LT) (82.54 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

magyar (HU) (68.7 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

Malti (MT) (84.23 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

Nederlands (NL) (49.82 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

polski (PL) (83.62 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

português (PT) (49.74 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

română (RO) (88.19 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

slovenčina (SK) (81.5 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

slovenščina (SL) (79.79 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

Suomi (FI) (49.15 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

svenska (SV) (50.18 KB - PDF)

First published: 30/09/2014Last updated: 30/09/2014
View

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

English (EN) (550.74 KB - PDF)

First published: Last updated:
View

CHMP post-authorisation summary of positive opinion for Ipreziv

AdoptedReference Number: EMA/CHMP/569645/2013

English (EN) (531.8 KB - PDF)

First published: Last updated:
View

Ipreziv : EPAR - Public assessment report

Adopted

English (EN) (1.72 MB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Ipreziv

AdoptedReference Number: EMA/CHMP/737200/2011

English (EN) (510.21 KB - PDF)

First published: Last updated:
View

More information on Ipreziv

Public statement on Ipreziv: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/710373/2014

English (EN) (66.02 KB - PDF)

First published: Last updated:
View
This page was last updated on

How useful do you find this page?