Cosentyx 150 mg solution for injection in pre-filled pen
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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 01 June 2023
File name
Cosentyx 150mg 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 as an ADR with ‘unknown’ frequency
Approval of new indication Hidradenitis Suppurativa
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 medical prescription which may not be renewed (A)
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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 medical prescription which may not be renewed (A)
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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 medical prescription which may not be renewed (A)
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Updated due to approval of new JIA indication.
Updated on 28 June 2022
File name
Cosentyx 150mg PFP REG PIL PF22-012 clean IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
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 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 medical prescription which may not be renewed (A)
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Section 4.8: updated to include “Dishydrotic eczema” as an ADR (frequency “uncommon”)
Updated on 23 May 2022
File name
Cosentyx 150mg 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
Updated to include “Dishydrotic eczema” as an ADR (frequency “uncommon”)
Updated on 23 February 2022
File name
Cosentyx 150mg PFP REG PIL_PF21-082_clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Correct PIL uploaded
Updated on 23 February 2022
File name
Cosentyx 150mg PFP REG PIL_PF21-082_clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Correct PIL uploaded
Updated on 27 January 2022
File name
Cosentyx 150mg 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
Update Section 3: Based on your response, further adjustments to your dose may be recommended by your doctor.
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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Correction of "change reason" selected for this update (Section 4,2 & 5.1 updated rather than Section 4.2 & 4.5)
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 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 4.5 - Interaction with other medicinal products and other forms of interaction
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 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 medical prescription which may not be renewed (A)
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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 medical prescription which may not be renewed (A)
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- SmPC Section 5.1: updated to include Week 52 data of Study CAIN457A2311
Updated on 17 August 2021
File name
Cosentyx 150mg REG PIL PF21-128 & GB (NI) August 2021 clean IPHA.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Rare ADR 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 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 22 July 2021
File name
Cosentyx 150mg REG PIL PF20-165 July 2021 clean.pdf
Reasons for updating
- Change to section 3 - use in children/adolescents
Free text change information supplied by the pharmaceutical company
Minor update to include information regarding availability of 75mg/.05ml pre-filled syringe for pediatric use
Updated on 22 July 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
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minro changes to relfect update of new 75mg/.05ml pre-filled syringe for pediatric use
Updated on 31 March 2021
File name
Cosentyx Soln for Inj in pre-filled pen & syringe REG SPC PF20-164 February 2021_IPHA.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
Section 5.1 updated to include MAXIMISE (CAIN457F3302) data
Updated on 02 December 2020
File name
Cosentyx 150mg REG PIL PF20-012 November 2020_clean.pdf
Reasons for updating
- Introduction of new pack/pack size
Free text change information supplied by the pharmaceutical company
Updated PIL for 150mg pre-filled pen to reflect approval of a new 300mg presentation. The new presentation has a separate PIL but the was product strength "150mg" added in various sections of this PIL to avoid confusion.
Updated on 02 December 2020
File name
Cosentyx Soln for Inj in pre-filled pen & syringe REG SPC November 2020_clean.pdf
Reasons for updating
- Addition of joint SPC covering all presentations
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Conbine founr presentations in one SPC
Approval of 300mg/2ml presentations
Updated on 22 September 2020
File name
Cosentyx 150mg REG-PIL PF20-129 marked_Sandoz.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of Fatigue, Nausea and Headache as ADRs
Updated on 22 September 2020
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF20-129 September 2020_clean unsigned.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
Addition of Fatigue, Nausea and Headache as ADRs (frequency “common”)
Updated on 13 August 2020
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF20-025 July 2020 (2) clean_unsigned.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated following approval of plaque psoriasis indication in children over 6 years of age
Updated on 13 August 2020
File name
Cosentyx 150mg REG-PIL PF20-025 clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Updated following approval of plaque psoriasis indication in children aged 6 years and older
Updated on 23 July 2020
File name
Cosentyx 150mg REG PIL PF20-023 clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 23 July 2020
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF20-023 July 2020 clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change in the warning for inflammatory bowel disease in Section 4.4
Updated on 06 May 2020
File name
Cosentyx 150mg REG PIL PF19-258 clean IE.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 06 May 2020
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC April 2020 clean_unsigned.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 Nr-AxSpA indication
Updated on 24 October 2019
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF19-104 October 2019 clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Correct month format from October 2019 to 10/2019
Updated on 24 October 2019
File name
Cosentyx REG PIL PF19-104 October 2019 clean.pdf
Reasons for updating
- Change to section 3 - dose and frequency
Updated on 24 October 2019
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF19-104 October 2019 clean IPHA.pdf
Reasons for updating
- 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
- Section 4.2 to allow AS patients to benefit from the up-titration dose to 300mg dose based on their clinical response.
- Section 4.8 to adjust the total number of patients treated with Cosentyx as part of clinical studies
- Section 5.1 to add the data supporting this posology update (study CAIN457F2314) including information on ASAS20, ASAS40 and also ASAS-PR
Updated on 03 October 2019
File name
Cosentyx Soln for Inj Autoinjector REG PIL PF19-120 TBI 28 Feb 2020.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 03 October 2019
File name
Cosentyx Soln for Inj Autoinjector REG PIL PF19-120 September 2019 TBI 28 Feb 2020.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 26 September 2019
File name
Cosentyx Soln for Inj Autoinjector REG PIL PF19-057 & 19-121 September 2019 clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 26 September 2019
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF19-120 September 2019 clean IPHA.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
- Update SmPC section 4.8 - Undesirable effects
- Addition of LRTI with frequency uncommon
- Addition of IBD with frequency uncommon
Updated on 10 September 2019
File name
Cosentyx Soln for Inj Autoinjector REG PIL PF19-057 & 19-121 September 2019 clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Removal of Black Inverted Triangle
Updated on 10 September 2019
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF19-057 & 19-121 September 2019 clean IPHA.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.9 - Overdose
- 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Majority of changes are editorial changes due to approval of first renewal.
Removal of black triangle
Addition of exfoliative dermatits as rare ADR in Section 4.8
Updated on 31 January 2019
File name
Cosentyx 2 x 150mg REG PIL 2217594 PF18-083 TBI 16 March 2019 IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
Updated on 31 October 2018
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF18-083 October 2018 clean 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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 updated to include up-titration to 300mg for PsA patients based on clinical response
Section 5.1 updated to include the radiographic data from FUTURE 5
Updated on 24 October 2018
File name
Cosentyx 2 x 150mg REG PIL 2212679 PF18-116 TBI 30 March 2019 IPHA.pdf
Reasons for updating
- Change to marketing authorisation holder
Updated on 02 October 2018
File name
Cosentyx Soln for Inj in pre-filled pen REG SPC PF18-177 clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: Update of the ‘Infections’ and ‘Crohn`s disease’ paragraphs
Updated on 23 May 2018
File name
CosentyxSolnforInjinpre-filledpenREGSPCPF18-116clean.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 October 2017
File name
PIL_16267_172.pdf
Reasons for updating
- New PIL for new product
Updated on 10 October 2017
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 5 - how to store or dispose
Updated on 06 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 September 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· Section 4.5: updated following analysis of study A2110 which demonstrated no interaction between secukinumab and midazolam (CYP3A4 substrate)
· Section 6.4: updated to include out of fridge storage conditions
Updated on 19 July 2017
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: Correction of the posology section of SmPC to enhance understanding of the loading regimen
Section 5.1: Update with data related to moderate to severe scalp psoriasis and long term 52 weeks results of head to head study vs Stelara (CLEAR study)
Section 5.1: Correction of PsARC figures
Updated on 30 May 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 06 April 2017
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
Updated on 26 May 2016
Reasons for updating
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 May 2016
Reasons for updating
- 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 on 21 January 2016
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 26 November 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 June 2015
Reasons for updating
- Change to further information section
Updated on 06 May 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 24 March 2015
Reasons for updating
- New PIL for new product
Updated on 12 March 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)