Thelin

sitaxentan sodium

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The marketing authorisation for Thelin has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Thelin : EPAR - Summary for the public BG = bălgarski 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public ES = español 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public CS = čeština 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public DA = dansk 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public DE = Deutsch 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public ET = eesti keel 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public EL = elliniká 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public EN = English 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public FR = français 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public IT = italiano 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public LV = latviešu valoda 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public LT = lietuvių kalba 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public HU = magyar 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public MT = Malti 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public NL = Nederlands 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public PL = polski 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public PT = português 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public RO = română 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public SK = slovenčina 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public SL = slovenščina 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public FI = suomi 2007-04-17 2011-03-02
Thelin : EPAR - Summary for the public SV = svenska 2007-04-17 2011-03-02

This EPAR was last updated on 02/03/2011 .

Authorisation details

Product details

Product details for Thelin
NameThelin
Agency product numberEMEA/H/C/000679
Active substance

sitaxentan sodium

International non-proprietary name (INN) or common name

sitaxentan sodium

Therapeutic area Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code C02KX03

Publication details

Publication details for Thelin
Marketing-authorisation holder

Pfizer Ltd.

Revision13
Date of issue of marketing authorisation valid throughout the European Union10/08/2006

Contact address:

Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

06/01/2011  Thelin -EMEA/H/C/000679 -T/0031

Name Language First published Last updated
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02
Thelin : EPAR - Product Information SV = svenska 2009-10-28 2011-03-02

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - All Authorised presentations SV = svenska 2007-04-17 2011-03-02

Name Language First published Last updated
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-04-22 2011-03-02

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Thelin : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-10-28 2011-03-02
Thelin-H-C-679-II-18 : EPAR - Assessment Report - Variation SV = svenska 2010-01-19 2011-03-02

Initial marketing-authorisation documents

Name Language First published Last updated
Thelin : EPAR - Procedural steps taken before authorisation SV = svenska 2007-04-17 2011-03-02
Thelin : EPAR - Scientific Discussion SV = svenska 2007-04-17 2011-03-02

Withdrawn

This medicine is now withdrawn from use in the European Union

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.