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Actelion Pharmaceuticals UK Ltd

Chiswick Tower 13th Floor, 389 Chiswick High Road, London, W4 4AL, UK
Telephone: +44 (0)208 987 3333
Fax: +44 (0)208 987 3322
WWW: http://www.actelion.com
Medical Information Direct Line: +44 (0)208 987 3333
Medical Information e-mail: medinfo_uk@actelion.com
Summary of Product Characteristics last updated on medicines.ie: 01/12/2017
SPC Uptravi

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01/12/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Oct-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Addition of site batch release
Updated on 12/10/2017 and displayed until 01/12/2017
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   07-Jul-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

DDI Midazolam
Updated on 12/07/2017 and displayed until 12/10/2017
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   29-Jun-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Concomitantuse of strong inhibitors of CYP2C8 
Updated on 22/02/2017 and displayed until 12/07/2017
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
Date of revision of text on the SPC:   13-Jan-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0Cartons of 10 or 60 film‑coated tablets, and 60or 140 film‑coated tablets (titration packs).$0$0EU/1/15/1083/011$0
Updated on 11/10/2016 and displayed until 22/02/2017
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Sep-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

10. September 2016
Updated on 19/05/2016 and displayed until 11/10/2016
Reasons for adding or updating:
  • New SPC for new product

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