Cosentyx 300mg solution for injection in pre-filled pen *
Pharmacy Only: Prescription

  • 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

Updated on 28 June 2022

File name

62bab5be022c6.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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)

Free text change information supplied by the pharmaceutical company

Updated due to approval of new JIA indication.

Updated on 23 May 2022

File name

628b96dfe4316.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 4.8: updated to include “Dishydrotic eczema” as an ADR (frequency “uncommon”)

Updated on 23 May 2022

File name

628b95dc6535e.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

Section 4.8: updated to include “Dishydrotic eczema” as an ADR (frequency “uncommon”)

Updated on 27 January 2022

File name

Cosentyx 150mg and 300mg pre-filled pen REG SPC PF21-082 January 2022_IPHA_1643285331.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

  • Section 4.2: Updated with the following sentence: Based on clinical response, a maintenance dose of 300 mg every 2 weeks may provide additional benefit for patients with a body weight of 90 kg or higher.
  • Section 4.2: Following sentence added to the Psoriasis Arthritis section: For patients with concomitant moderate to severe plaque psoriasis, please refer to adult plaque psoriasis recommendation.
  • Section 5.1: Updated with the results of the Plaque psoriasis dose flexibility trial

Updated on 27 January 2022

File name

Cosentyx 300mg PFS REG PIL_PF21-082 clean IPHA_1643285272.pdf

Reasons for updating

  • Change to section 3 - dose and frequency

Free text change information supplied by the pharmaceutical company

Sectipn 3 updated with; Based on your response, further adjustments to your dose may be recommended by your doctor.

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