Overview

The marketing authorisation for Possia has been withdrawn at the request of the marketing-authorisation holder.

Possia : EPAR - Summary for the public

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dansk (DA) (278.34 KB - PDF)

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Deutsch (DE) (338.67 KB - PDF)

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eesti keel (ET) (200.98 KB - PDF)

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ελληνικά (EL) (285.03 KB - PDF)

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français (FR) (263 KB - PDF)

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italiano (IT) (202.23 KB - PDF)

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latviešu valoda (LV) (313.57 KB - PDF)

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lietuvių kalba (LT) (229.54 KB - PDF)

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magyar (HU) (303.85 KB - PDF)

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Malti (MT) (248.52 KB - PDF)

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Nederlands (NL) (260.43 KB - PDF)

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polski (PL) (250.23 KB - PDF)

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português (PT) (201.13 KB - PDF)

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română (RO) (230.06 KB - PDF)

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slovenčina (SK) (307.1 KB - PDF)

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slovenščina (SL) (240.57 KB - PDF)

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Suomi (FI) (201.24 KB - PDF)

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svenska (SV) (198.69 KB - PDF)

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Product information

Possia : EPAR - Product Information

English (EN) (805.47 KB - PDF)

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български (BG) (1.27 MB - PDF)

First published: 07/01/2011Last updated: 01/02/2013
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español (ES) (722.27 KB - PDF)

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čeština (CS) (955.11 KB - PDF)

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dansk (DA) (624.97 KB - PDF)

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Deutsch (DE) (718.62 KB - PDF)

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eesti keel (ET) (734.64 KB - PDF)

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ελληνικά (EL) (1.26 MB - PDF)

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français (FR) (757.4 KB - PDF)

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íslenska (IS) (626.98 KB - PDF)

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italiano (IT) (709.78 KB - PDF)

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latviešu valoda (LV) (1.05 MB - PDF)

First published: 07/01/2011Last updated: 01/02/2013
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lietuvių kalba (LT) (760.99 KB - PDF)

First published: 07/01/2011Last updated: 01/02/2013
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magyar (HU) (959.74 KB - PDF)

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Malti (MT) (868.76 KB - PDF)

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Nederlands (NL) (721.11 KB - PDF)

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norsk (NO) (628.65 KB - PDF)

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polski (PL) (1.36 MB - PDF)

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português (PT) (1.03 MB - PDF)

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română (RO) (794.52 KB - PDF)

First published: 07/01/2011Last updated: 01/02/2013
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slovenčina (SK) (987.96 KB - PDF)

First published: 07/01/2011Last updated: 01/02/2013
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slovenščina (SL) (953.01 KB - PDF)

First published: 07/01/2011Last updated: 01/02/2013
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Suomi (FI) (656.85 KB - PDF)

First published: 07/01/2011Last updated: 01/02/2013
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svenska (SV) (637.11 KB - PDF)

First published: 07/01/2011Last updated: 01/02/2013
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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).

Possia : EPAR - All Authorised presentations

English (EN) (548.06 KB - PDF)

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български (BG) (617.58 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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español (ES) (573.16 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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čeština (CS) (563.56 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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dansk (DA) (575.82 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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Deutsch (DE) (557.18 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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eesti keel (ET) (558 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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ελληνικά (EL) (954.96 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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français (FR) (587.04 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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íslenska (IS) (549.89 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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italiano (IT) (584.58 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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latviešu valoda (LV) (611.74 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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lietuvių kalba (LT) (572.93 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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magyar (HU) (591.4 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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Malti (MT) (572.61 KB - PDF)

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Nederlands (NL) (548.36 KB - PDF)

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norsk (NO) (586.22 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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polski (PL) (600.78 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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português (PT) (574.41 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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română (RO) (609.93 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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slovenčina (SK) (569.01 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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slovenščina (SL) (553.5 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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Suomi (FI) (578.65 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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svenska (SV) (575.55 KB - PDF)

First published: 07/01/2011Last updated: 07/01/2011
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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
Revision
2

Assessment history

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

English (EN) (238.95 KB - PDF)

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Possia : EPAR - Public assessment report

English (EN) (987.53 KB - PDF)

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CHMP summary of positive opinion for Possia

AdoptedReference Number: EMA/538872/2010

English (EN) (182.09 KB - PDF)

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More information on Possia

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

Reference Number: EMA/212211/2013

English (EN) (57.49 KB - PDF)

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