Cosentyx 150 mg solution for injection in pre-filled pen

Product Information *

  • Company:

    Novartis Ireland Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 22 July 2021

File name

Cosentyx 150mg REG PIL PF20-165 July 2021 clean_1626950166.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_1626949531.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_1617183257.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_1606908465.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_1606907436.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_1600787792.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_1600785826.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_1597314753.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_1597314460.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_1595507031.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_1595497078.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_1588757057.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_1588752942.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_1571937501.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_1571937419.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_1571935375.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_1570095081.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_1570094755.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_1569511126.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_1569507892.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_1568103725.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_1568102983.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_1548923535.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_1540999433.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_1540381337.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_1538468776.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

  • 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 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 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

“Mucosal and cutaneous candidiasis (including oesophageal candidiasis)” has been added with “Frequency not known”.

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

Remove MA details for pack size EU/1/14/980/007 as it is currently not available on the Irish market

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

New clinical data from clinical trials specifically Head to Head data with Stelara as well as the benefits in patients that have concomitant nail or palmoplantar involvement of their psoriasis.

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

Update to reflect approval of two new indications for Ankylosing Spondylitis and Psoriatic Arthritis

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

Addition of new pack sizes

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)

Free text change information supplied by the pharmaceutical company

None provided