Cosentyx 300mg solution for injection in pre-filled pen *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal 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

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 26 August 2021

File name

Cosentyx 150mg & 300mg Soln for Inj in pre-filled pen REG SPC PF21-088 August 2021_clean IPHA_1629988794.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

SmPC Section 5.1: updated to include Week 52 data of Study CAIN457A2311

Updated on 26 August 2021

File name

Cosentyx 150mg & 300mg Soln for Inj in pre-filled pen REG SPC PF21-088 August 2021_clean IPHA_1629963943.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

  • SmPC Section 5.1: updated to include Week 52 data of Study CAIN457A2311

Updated on 17 August 2021

File name

Cosentyx 300mg REG PIL PF21-128 & GB (NI)_August 2021 clean_1629197947.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Rare side effect added: inflammation of small blood vessels, which can lead to a skin rash with small red or purple bumps (vasculitis)

Updated on 17 August 2021

File name

Cosentyx 150mg & 300mg Soln for Inj in pre-filled pen & syringe REG SPC PF21-128 August 2021_clean IPHA_1629197885.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

SmPC Section 4.8: updated to include “Hypersensitivity vasculitis” as an ADR (frequency “rare”)

 

Updated on 04 August 2021

File name

Cosentyx 150mg & 300mg Soln for Inj in pre-filled pen & syringe REG SPC PF20-165 July 2021_IPHA_1628076584.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

New product entry for new 300mg strength

Updated on 04 August 2021

File name

Cosentyx 300mg REG PIL PF20-165 July 2021 clean IPHA_1628076473.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL for new strength

Updated on 04 August 2021

File name

Cosentyx 150mg & 300mg Soln for Inj in pre-filled pen & syringe REG SPC PF20-165 July 2021_IPHA_1628074725.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

New SPC for new strength