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The marketing authorisation for Thelin has been withdrawn at the request of the marketing authorisation holder.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 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public ES = español 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public CS = čeština 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public DA = dansk 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public DE = Deutsch 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public ET = eesti keel 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public EL = elliniká 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public EN = English 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public FR = français 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public IT = italiano 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public LV = latviešu valoda 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public LT = lietuvių kalba 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public HU = magyar 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public MT = Malti 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public NL = Nederlands 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public PL = polski 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public PT = português 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public RO = română 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public SK = slovenčina 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public SL = slovenščina 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public FI = suomi 17/04/2007 02/03/2011
Thelin : EPAR - Summary for the public SV = svenska 17/04/2007 02/03/2011

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

More detail is available in the summary of product characteristics

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 BG = bălgarski 28/10/2009 02/03/2011
Thelin : EPAR - Product Information ES = español 28/10/2009 02/03/2011
Thelin : EPAR - Product Information CS = čeština 28/10/2009 02/03/2011
Thelin : EPAR - Product Information DA = dansk 28/10/2009 02/03/2011
Thelin : EPAR - Product Information DE = Deutsch 28/10/2009 02/03/2011
Thelin : EPAR - Product Information ET = eesti keel 28/10/2009 02/03/2011
Thelin : EPAR - Product Information EL = elliniká 28/10/2009 02/03/2011
Thelin : EPAR - Product Information EN = English 28/10/2009 02/03/2011
Thelin : EPAR - Product Information FR = français 28/10/2009 02/03/2011
Thelin : EPAR - Product Information IT = italiano 28/10/2009 02/03/2011
Thelin : EPAR - Product Information LV = latviešu valoda 28/10/2009 02/03/2011
Thelin : EPAR - Product Information LT = lietuvių kalba 28/10/2009 02/03/2011
Thelin : EPAR - Product Information HU = magyar 28/10/2009 02/03/2011
Thelin : EPAR - Product Information MT = Malti 28/10/2009 02/03/2011
Thelin : EPAR - Product Information NL = Nederlands 28/10/2009 02/03/2011
Thelin : EPAR - Product Information PL = polski 28/10/2009 02/03/2011
Thelin : EPAR - Product Information PT = português 28/10/2009 02/03/2011
Thelin : EPAR - Product Information RO = română 28/10/2009 02/03/2011
Thelin : EPAR - Product Information SK = slovenčina 28/10/2009 02/03/2011
Thelin : EPAR - Product Information SL = slovenščina 28/10/2009 02/03/2011
Thelin : EPAR - Product Information FI = suomi 28/10/2009 02/03/2011
Thelin : EPAR - Product Information SV = svenska 28/10/2009 02/03/2011
Thelin : EPAR - Product Information IS = Islenska 28/10/2009 02/03/2011
Thelin : EPAR - Product Information NO = Norsk 28/10/2009 02/03/2011

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 BG = bălgarski 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations ES = español 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations CS = čeština 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations DA = dansk 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations DE = Deutsch 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations ET = eesti keel 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations EL = elliniká 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations EN = English 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations FR = français 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations IT = italiano 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations LV = latviešu valoda 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations LT = lietuvių kalba 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations HU = magyar 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations MT = Malti 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations NL = Nederlands 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations PL = polski 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations PT = português 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations RO = română 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations SK = slovenčina 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations SL = slovenščina 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations FI = suomi 17/04/2007 02/03/2011
Thelin : EPAR - All Authorised presentations SV = svenska 17/04/2007 02/03/2011
Name Language First published Last updated
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV BG = bălgarski 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV ES = español 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV CS = čeština 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV DA = dansk 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV DE = Deutsch 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV ET = eesti keel 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV EL = elliniká 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV EN = English 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV FR = français 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV IT = italiano 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV LV = latviešu valoda 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV LT = lietuvių kalba 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HU = magyar 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV MT = Malti 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV NL = Nederlands 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV PL = polski 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV PT = português 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV RO = română 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SK = slovenčina 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SL = slovenščina 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV FI = suomi 22/04/2009 02/03/2011
Thelin : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 22/04/2009 02/03/2011

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 (English only) 28/10/2009 02/03/2011
Thelin-H-C-679-II-18 : EPAR - Assessment Report - Variation (English only) 19/01/2010 02/03/2011

Initial marketing-authorisation documents

Name Language First published Last updated
Thelin : EPAR - Scientific Discussion (English only) 17/04/2007 02/03/2011
Thelin : EPAR - Procedural steps taken before authorisation (English only) 17/04/2007 02/03/2011

Withdrawn

This medicine is now withdrawn from use in the European Union