Possia

Withdrawn

This medicine's authorisation has been withdrawn

ticagrelor

Overview

On 3 December 2010, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Possia, (ticagrelor), which had been approved for the prevention of atherothrombotic events. The marketing authorisation holder (MAH) responsible for Possia was AstraZeneca AB. 

On 27 March 2013, the European Commission issued a decision to withdraw the marketing authorisation for Possia, following its receipt of a letter dated 20 December 2012 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. Possia was not marketed in any European country. 

Pursuant to this decision, the European public assessment report for Possia is updated to reflect that the marketing authorisation is no longer valid.

Possia : EPAR - Summary for the public

Product information

Possia : EPAR - Product Information

Possia : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Possia
• Active substance:
  Ticagrelor
• International non-proprietary name (INN) or common name:
  ticagrelor
• Therapeutic area (MeSH):
  • Peripheral Vascular Diseases
  • Acute Coronary Syndrome
• Anatomical therapeutic chemical (ATC) code:
  B01AC24

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).

Authorisation details

• EMA product number:
  EMEA/H/C/002303
• Marketing authorisation holder:
  AstraZeneca AB

  Gärtunavägen; 151 85 Södertälje; Sweden

• Marketing authorisation issued:
  03/12/2010
• Withdrawal of marketing authorisation:
  27/03/2013
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Possia : EPAR - Public assessment report

CHMP summary of positive opinion for Possia

AdoptedReference Number: EMA/538872/2010