We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Novartis Ireland Limited

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 11/10/2017
SPC Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film coated tablets

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 11/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   28-Sep-2017
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 28/03/2017 and displayed until 11/10/2017
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   16-Mar-2017
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 27/07/2016 and displayed until 28/03/2017
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:   16-Jun-2016
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 15/02/2016 and displayed until 27/07/2016
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
Date of revision of text on the SPC:   05-Feb-2016
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 01/12/2015 and displayed until 15/02/2016
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   Valsartan
   Sacubitril