Cosentyx 150 mg solution for injection in pre-filled pen

  • Name:

    Cosentyx 150 mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    secukinumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/10/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 24/10/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Novartis Ireland Limited

Novartis Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Aclasta 5 mg solution for infusion Active Ingredients Zoledronic acid monohydrate
Medicine Name Afinitor Tablets Active Ingredients Everolimus
Medicine Name Aimovig Active Ingredients Erenumab
Medicine Name Atriance 5 mg/ml solution for infusion Active Ingredients Nelarabine
Medicine Name Azarga 10mg/ml + 5mg/ml eye drops, suspension Active Ingredients Brinzolamide, Timolol Maleate
Medicine Name Azopt 10mg/ml eye drops suspension Active Ingredients Brinzolamide
Medicine Name Cataflam 50 mg Coated Tablets Active Ingredients Diclofenac Potassium
Medicine Name Certican Tablets Active Ingredients Everolimus
Medicine Name CILOXAN 3 mg/ml ear drops, solution Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Co-Diovan 160 mg/12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 160mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 80mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Cosentyx 150 mg solution for injection in pre-filled pen Active Ingredients secukinumab
Medicine Name Desferal 500mg Vials Active Ingredients Desferrioxamine Mesylate
Medicine Name Diovan 160 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 320mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 3mg/ml Oral Solution Active Ingredients Valsartan
Medicine Name Diovan 40 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 80 mg film-coated tablets Active Ingredients Valsartan
Medicine Name DuoTrav Eye Drops Solution Active Ingredients Timolol Maleate, Travoprost
Medicine Name Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets Active Ingredients Sacubitril, Valsartan
Medicine Name Estradot Transdermal Patches Active Ingredients Estradiol Hemihydrate
Medicine Name Eucreas 50mg / 850mg and 50mg / 1000mg film-coated tablets Active Ingredients Metformin Hydrochloride, Vildagliptin
1 - 0 of 116 items.Total: Infinity pages

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 24 October 2019 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 6 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 July 2017 SmPC

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 SmPC

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 SmPC

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 3 May 2016 SmPC

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 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 SmPC

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 PIL

Reasons for updating

  • Change to further information section

Updated on 6 May 2015 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 March 2015 SmPC

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