Overview

The marketing authorisation for Thelin has been withdrawn at the request of the marketing authorisation holder.

Thelin : EPAR - Summary for the public

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eesti keel (ET) (285.38 KB - PDF)

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ελληνικά (EL) (388.19 KB - PDF)

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italiano (IT) (349.42 KB - PDF)

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latviešu valoda (LV) (352.98 KB - PDF)

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lietuvių kalba (LT) (316.89 KB - PDF)

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magyar (HU) (338.56 KB - PDF)

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Malti (MT) (406.16 KB - PDF)

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Nederlands (NL) (285.24 KB - PDF)

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polski (PL) (346.97 KB - PDF)

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português (PT) (348.72 KB - PDF)

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română (RO) (376.34 KB - PDF)

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slovenčina (SK) (346.2 KB - PDF)

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slovenščina (SL) (338.93 KB - PDF)

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Suomi (FI) (287.48 KB - PDF)

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svenska (SV) (347.88 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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Product information

Thelin : EPAR - Product Information

English (EN) (561.78 KB - PDF)

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български (BG) (1.06 MB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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español (ES) (559.73 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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čeština (CS) (850.38 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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dansk (DA) (579.58 KB - PDF)

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Deutsch (DE) (588.47 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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eesti keel (ET) (550.62 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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ελληνικά (EL) (1.09 MB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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français (FR) (565.06 KB - PDF)

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íslenska (IS) (572.14 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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italiano (IT) (582.01 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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latviešu valoda (LV) (872.17 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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lietuvių kalba (LT) (573.31 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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magyar (HU) (874.73 KB - PDF)

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Malti (MT) (933.02 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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Nederlands (NL) (565.77 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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norsk (NO) (562.94 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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polski (PL) (881.59 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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português (PT) (577.03 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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română (RO) (551.07 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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slovenčina (SK) (878.03 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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slovenščina (SL) (844.39 KB - PDF)

First published: 29/10/2009Last updated: 02/03/2011
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Suomi (FI) (576.67 KB - PDF)

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svenska (SV) (564.5 KB - PDF)

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Latest procedure affecting product information: T/0031

06/01/2011

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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).

Thelin : EPAR - All Authorised presentations

English (EN) (212.79 KB - PDF)

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български (BG) (302.55 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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español (ES) (212.78 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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čeština (CS) (286.77 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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dansk (DA) (212.72 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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Deutsch (DE) (212.71 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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eesti keel (ET) (212.78 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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ελληνικά (EL) (292.68 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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français (FR) (212.8 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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italiano (IT) (221.33 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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latviešu valoda (LV) (288.52 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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lietuvių kalba (LT) (280.09 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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magyar (HU) (250.21 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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Malti (MT) (310.85 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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Nederlands (NL) (212.59 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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polski (PL) (252.43 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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português (PT) (212.8 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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română (RO) (282.96 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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slovenčina (SK) (285.63 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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slovenščina (SL) (285.94 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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Suomi (FI) (212.69 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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svenska (SV) (212.78 KB - PDF)

First published: 17/04/2007Last updated: 02/03/2011
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Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

English (EN) (294.19 KB - PDF)

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български (BG) (361.79 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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español (ES) (304.05 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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čeština (CS) (329.04 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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dansk (DA) (298.71 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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Deutsch (DE) (305.21 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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eesti keel (ET) (296.51 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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ελληνικά (EL) (366.93 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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français (FR) (303.69 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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italiano (IT) (294.48 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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latviešu valoda (LV) (332.04 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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lietuvių kalba (LT) (305.37 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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magyar (HU) (325.61 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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Malti (MT) (344.82 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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Nederlands (NL) (305.22 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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polski (PL) (337.48 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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português (PT) (299.44 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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română (RO) (301.31 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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slovenčina (SK) (333.66 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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slovenščina (SL) (326.71 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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Suomi (FI) (296.53 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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svenska (SV) (297.57 KB - PDF)

First published: 22/04/2009Last updated: 02/03/2011
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Product details

Name of medicine
Thelin
Active substance
sitaxentan sodium
International non-proprietary name (INN) or common name
sitaxentan sodium
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
C02KX03

Pharmacotherapeutic group

Antihypertensives

Therapeutic indication

Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.

Authorisation details

EMA product number
EMEA/H/C/000679
Marketing authorisation holder
Pfizer Ltd.

Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Marketing authorisation issued
10/08/2006
Revision
13

Assessment history

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

English (EN) (351.49 KB - PDF)

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Thelin-H-C-679-II-18 : EPAR - Assessment Report - Variation

Adopted

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Thelin : EPAR - Scientific Discussion

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Thelin : EPAR - Procedural steps taken before authorisation

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More information on Thelin

This product originally had an orphan designation granted on 21 October 2004. This designation was withdrawn from the Community register of orphan medicinal products in 4 March 2013 upon request of the marketing authorisation holder.

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

AdoptedReference Number: EMA/149536/2011

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