Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets

  • Name:

    Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Sacubitril, Valsartan

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/11/19

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Summary of Product Characteristics last updated on medicines.ie: 28/11/2019
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

Novartis Ireland Limited

Novartis Ireland Limited

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Medicine Name Co-Diovan 320mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 80mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
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Medicine Name Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets Active Ingredients Sacubitril, Valsartan
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1 - 0 of 116 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 28 November 2019 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 be renewed (B)

Updated on 28 November 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 26 November 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 8 April 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 September 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 21 August 2018 PIL

Reasons for updating

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

Updated on 14 May 2018 SmPC

Reasons for updating

  • 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 be renewed (B)

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 November 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 17 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 11 October 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5 - addition of multipacks containing 196 (7x28) film‑coated tablets.

Updated on 28 March 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.3 - Shelf life was increased from 30 months to 3 years

Updated on 27 July 2016 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5 - Added "No clinically relevant drug-drug interaction was observed when simvastatin and Entresto were co-administered." under the heading

Interactions requiring precautions; OATP1B1 and OATP1B3 substrates, e.g. statins

Updated on 14 March 2016 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 15 February 2016 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5: updated to include new pack sizes
Section 8: updated to include the new EU numbers corresponding to new pack sizes

Updated on 1 December 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 November 2015 PIL

Reasons for updating

  • New PIL for new product