Uptravi
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 December 2024
File name
EN-IE-Uptravi-20241216-SmPC-IB-237755-clean-approved.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMA/VR/0000237755: Submission of a type IB variation to update the EUPI with the in-use stability data of 3 months, the outer carton and bottle label.
Updated on 23 December 2024
File name
EN-IE-Uptravi-20241216-PIL-IB-237755-clean-approved.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Free text change information supplied by the pharmaceutical company
EMA/VR/0000237755: Submission of a type IB variation to update the EUPI with the in-use stability data of 3 months, the outer carton and bottle label.
Updated on 21 November 2024
File name
EN-IE-Uptravi-20241114-SmPC-PSUSA-10503-202312-clean-approved.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/003774/PSUSA/00010503/202312: 10th PSUR: Addition of angioedema to Section 4.8 of the SmPC and Section 4 of the PIL
Updated on 21 November 2024
File name
EN-IE-Uptravi-20241114-PIL-PSUSA-10503-202312-clean-approved.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
EMEA/H/C/003774/PSUSA/00010503/202312: 10th PSUR: Addition of angioedema to Section 4.8 of the SmPC and Section 4 of the PIL
Updated on 03 April 2024
File name
EN-Uptravi-20240125-IE-SPC-X-038-Clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Line extension to introduce a 100 µg film-coated tablet strength
Updated on 03 April 2024
File name
EN-Uptravi-20240125-IE-PIL-X-038-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Line extension to introduce a 100 mcg film-coated tablet strength
Updated on 14 December 2023
File name
IE - UKNI _Uptravi SmPC - extend the shelf-life from 36 to 48 months_Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Haemoglobin decrease
In a Phase 3 placebo‑controlled study in patients with PAH, mean absolute changes in haemoglobin at regular visits compared to baseline ranged from -0.34 to -0.02 g/dL in the selexipag group compared to -0.05 to 0.25 g/dL in the placebo group. A decrease from baseline in haemoglobin concentration to below 10 g/dL was reported in 8.6% of selexipag‑treated patients and 5.0% of placebo‑treated patients.
In a phase 3 placebo-controlled study in patients newly diagnosed with PAH, mean absolute changes in haemoglobin at regular visits compared to baseline ranged from -1.77 to -1.26 g/dL in the triple therapy group (selexipag, macitentan, tadalafil) compared to -1.61 to -1.28 g/dL in the double therapy group (placebo, macitentan and tadalafil). A decrease from baseline in haemoglobin concentration to below 10 g/dL was reported in 19.0% of patients in the triple therapy group and 14.5% in the double therapy group. Anaemia was reported with very common frequency (13.4%) in the triple therapy group compared to common frequency (8.3%) in the double therapy group.
6.3 Shelf life
34 years
Updated on 20 May 2022
File name
NI and IE Uptravi SmPC C05 19May2022 Clean.pdf
Reasons for updating
- 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 20 May 2022
File name
NI and IE Uptravi PIL C05 19May2022 Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
File name
HCP Letter IE Clean 16 Dec 21.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Change to format/layout. Removed black triangle as no longer applicable
File name
Patient Tritation Guide IE clean 16 Dec 21.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Change to format/layout. Removed black triangle as no longer applicable
File name
HCP titration Guide IE clean 16 Dec 21.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Change to format/layout. Removed black triangle as no longer applicable
Updated on 19 March 2021
File name
NI and IE Uptravi SmPC C04 9March2021 EDMS-ERI-205912252 V23 Clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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
Addition of license renewal date and correction of typo in section 4.8
Updated on 19 March 2021
File name
NI and IE Uptravi PIL C04 9March2021 EDMS-ERI-205912252 V23 Clean.pdf
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 batch release site and local representative in UK (Northern Ireland).
Updated on 13 January 2021
File name
IRE Uptravi PIL C03 day27 11Jan2021 clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Change local representative details and correction to typing errors.
Updated on 13 January 2021
File name
Uptravi SmPC C03 day27 11Jan2021 clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
Updated to include long-term treatment of PAH based on survival and safety data.
Updated on 22 December 2020
File name
Uptravi SmPC C02 CD 14Dec2020 clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
- Removal of Black Inverted Triangle
- Change to improve clarity and readability
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Uptravi (selexipag) is removed from the additional monitoring list as a new active substance following five years of authorisation. Therefore, the statement that this medicinal product is subject to additional monitoring and that this will allow quick identification of new safety information, preceded by an inverted equilateral black triangle, is removed from the summary of product characteristics and the package leaflet.
Some QRD related changes have also been made.
Updated on 22 December 2020
File name
Ireland Uptravi PIL C02 CD 14Dec2020 clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Uptravi (selexipag) is removed from the additional monitoring list as a new active substance following five years of authorisation. Therefore, the statement that this medicinal product is subject to additional monitoring and that this will allow quick identification of new safety information, preceded by an inverted equilateral black triangle, is removed from the summary of product characteristics and the package leaflet.
Some QRD related changes have also been made.
Updated on 22 December 2020
File name
Ireland Uptravi PIL C02 CD 14Dec2020 clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Uptravi (selexipag) is removed from the additional monitoring list as a new active substance following five years of authorisation. Therefore, the statement that this medicinal product is subject to additional monitoring and that this will allow quick identification of new safety information, preceded by an inverted equilateral black triangle, is removed from the summary of product characteristics and the package leaflet.
Some QRD related changes have also been made.
File name
Uptravi IRE HCP Letter 19Oct 2020.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Change local representative and contact details
File name
Uptravi IRE Patient Titration Guide 19Oct2020.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Change local representative and contact details
File name
Uptravi IRE HCP Titration Guide 19Oct2020.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Change local representative and contact details
File name
Uptravi HCP Letter Updated 2019.pdf
Reasons for updating
- Add New Doc
File name
Uptravi Patient Titration Guide Updated 2019.pdf
Reasons for updating
- Add New Doc
Updated on 25 February 2020
File name
Uptravi SmPC C01 CHMP 19 Feb 2020 clean.pdf
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
File name
Uptravi PIL C01 CHMP 19 Feb 2020 clean.pdf
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.
File name
T2370 - 17362 Uptravi Titration Guide Update_Digital.pdf
Reasons for updating
- Add New Doc
Updated on 09 August 2019
File name
Uptravi PIL-25 July 19.pdf
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 08 August 2019
File name
Uptravi SPC-clean-25 July 19.pdf
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
File name
Uptravi PIL Nov 2018.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 24 October 2018
File name
EN_Uptravi_h-3774-MAH transfer_AppV_PI-I-III_clean_11October2018 PIL.pdf
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
File name
EN_Uptravi_h-3774-MAH transfer_AppV_PI-I-III_clean_11October2018 SPC.pdf
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 06 June 2018
File name
UptraviSmPCApril2018.docx
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
File name
Uptravi-PIL-April 2018.pdf
Reasons for updating
- Change to date of revision
Updated on 01 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 December 2017
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
Updated on 29 November 2017
File name
PIL_16743_802.pdf
Reasons for updating
- New PIL for new product
Updated on 29 November 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 October 2017
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
Updated on 12 October 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 July 2017
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
Updated on 10 July 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 22 February 2017
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
Updated on 21 February 2017
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 11 October 2016
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
Updated on 10 October 2016
Reasons for updating
- Change of manufacturer
- Change to warnings or special precautions for use
Updated on 19 May 2016
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
Reasons for updating
- New PIL for new product