Uptravi

  • Name:

    Uptravi

  • Company:
    info
  • Active Ingredients:

    Selexipag

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/02/20

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Summary of Product Characteristics last updated on medicines.ie: 25/2/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Actelion, a division of Janssen-Cilag International NV

unnamed (2)

Company Products

Medicine NameActive Ingredients
Medicine Name Opsumit 10mg Active Ingredients Macitentan
Medicine Name Tracleer 125mg Active Ingredients Bosentan monohydrate
Medicine Name Tracleer 62.5 mg Active Ingredients Bosentan monohydrate
Medicine Name Uptravi Active Ingredients Selexipag
Medicine Name VELETRI 0.5 mg, Powder for Solution for Infusion Active Ingredients Epoprostenol Sodium
Medicine Name VELETRI 1.5 mg, Powder for Solution for Infusion Active Ingredients Epoprostenol Sodium
Medicine Name Zavesca 100mg hard capsules Active Ingredients Miglustat
1 - 0 of 7 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 17 March 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 17 March 2020 Ed-Both

Reasons for updating

  • Add New Doc

Updated on 25 February 2020 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Editorial changes.

Updated on 25 February 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to manufacturer responsible for batch release site.

Updated on 12 December 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 9 August 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect

Updated on 8 August 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 November 2018 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 24 October 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 24 October 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Summary of Changes

Section 4.8:

Addition of:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed below.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

 

Section 7:

Removal of:

Actelion Registration Ltd

Chiswick Tower 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

 

Addition of:

Janssen-Cilag International NV

Turnhoutseweg 30

B 2340 Beerse

Belgium

 

Section 10:

Date of revision of text: October 2018

 

Updated on 6 June 2018 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 April 2018 PIL

Reasons for updating

  • Change to date of revision

Updated on 1 December 2017 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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 1 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 29 November 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 October 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 October 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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 July 2017 SmPC

Reasons for 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

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 10 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 22 February 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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 21 February 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 11 October 2016 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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 10 October 2016 PIL

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use

Updated on 19 May 2016 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 May 2016 PIL

Reasons for updating

  • New PIL for new product