Nilemdo 180mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Daiichi Sankyo Ireland Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 29 November 2024

File name

nilemdo-smpc-ie-v02-241118.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Updated on 29 November 2024

File name

nilemdo-pil-ie-v04-2411.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 30 August 2024

File name

nilemdo-smpc-ie-v01-240510-Medicines.ie.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 30 August 2024

File name

nilemdo-pil-ie-v02-2405-Medicines.ie.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company