Cosentyx 150 mg solution for injection in pre-filled pen
- Name:
Cosentyx 150 mg solution for injection in pre-filled pen
- Company:
Novartis Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/12/20
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Novartis Ireland Limited
Company Products
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 2 December 2020 PIL
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 2 December 2020 SPC
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 PIL
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 SPC
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 SPC
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 PIL
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 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 23 July 2020 SPC
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 6 May 2020 PIL
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 6 May 2020 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 3 - dose and frequency
Updated on 24 October 2019 SPC
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 3 October 2019 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 3 October 2019 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 26 September 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 26 September 2019 SPC
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 PIL
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 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 2 October 2018 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 5 - how to store or dispose
Updated on 10 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 6 September 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 6 September 2017 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 6 April 2017 SPC
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 SPC
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 3 May 2016 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to further information section
Updated on 6 May 2015 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 12 March 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)