Possia

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Withdrawn

This medicine's authorisation has been withdrawn

ticagrelor
MedicineHumanWithdrawn

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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decision, the European public assessment report for Possia is updated to reflect that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information:WS/0292
24/10/2012
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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).

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norsk (NO) (586.22 KB - PDF)

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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

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