Cosentyx 300mg solution for injection in pre-filled pen
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 31 March 2025
File name
Cosentyx 300mg REG PIL PF25-052 clean IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 31 March 2025
File name
Cosentyx 150mg & 300mg REG SPC PF25-052 February 2025_clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Addition of warning regarding active/latent tuberculosis in patients treated with secukinumab
Updated on 25 November 2024
File name
Cosentyx 150mg & 300mg REG SPC PF24-075 November 2024_clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update Section 4.4 with information on Hepatitis B reactivation
Update Section 4.8 with two new adverse reactions - eczema (common) and angioedema (rare)
Updated on 25 November 2024
File name
Cosentyx 300mg REG PIL PF24-075 clean IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of information regarding Hepatitis B infection and two new possible side effects (eczema and angioedema)
Updated on 29 August 2024
File name
Cosentyx 300mg PFP REG PIL Removal of UK(NI) & switch to Schaftenau_August 2024.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Updated to remove reference to UK (Northern Ireland)
Updated on 01 June 2023
File name
Cosentyx 150mg & 300mg REG SPC_PF22-039 & 23-021 May 2023 clean IPHA.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
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Pyoderma Gangrenosum added to Section 4.8 as an ADR with ‘unknown’ frequency
Approval of new indication Hidradenitis Suppurativa
Updated on 01 June 2023
File name
Cosentyx 300mg PFP REG PIL PF22-039 and 23-021 clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Pyoderma Gangrenosum added to Section 4.8 as an ADR with ‘unknown’ frequency Approval of new indication Hidradenitis Suppurativa
Updated on 08 February 2023
File name
Cosentyx 150mg & 300mg REG SPC_PF23-008_19.01.2023_clean IPHA.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Shelf life increased from 18 months to 2 years
Updated on 28 June 2022
File name
Cosentyx 150mg & 300mg REG SPC_PF22-012_20.06.22_clean IPHA.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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated due to approval of new JIA indication.
Updated on 23 May 2022
File name
Cosentyx 300mg PFP REG PIL PF22-001 clean IPHA.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
Cosentyx 150mg & 300mg PFP REG SPC PF22-001_31.03.2022_IPHA.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
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.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 restricted prescription (C)
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.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.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
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.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
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.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.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
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.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to restricted prescription (C)
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.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.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
New SPC for new strength
Novartis Ireland Limited
Address:
Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, IrelandMedical Information E-mail:
medinfo.dublin@novartis.comTelephone:
+353 1 2601255Fax:
+353 1 2601263