Stelara 90 mg solution for injection in pre-filled syringe

  • Name:

    Stelara 90 mg solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Ustekinumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/02/20

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Summary of Product Characteristics last updated on medicines.ie: 3/3/2020

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Janssen Sciences Ireland

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1 - 0 of 59 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 3 March 2020 SmPC

Reasons for updating

  • Other

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

Updated on 27 February 2020 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 27 January 2020 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Addition of paediatric plaque psoriasis information for children from the age of 6. Shortening of local representtaive contact address. 

Updated on 27 January 2020 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Addition of paediatric plaque psoriasis information for children from the age of 6. Shortened local representative contact  address.

Updated on 27 January 2020 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.1, 4.2, 4.8, 5.1, 5.2: addition of paediatric plaque psoriasis information for children from the age of 6.

Section 6.6: addition of recommendation on syringe size for single dose vial.

Updated on 27 January 2020 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Addition of paediatric plaque psoriasis information for children from the age of 6. Shortening of local representative contact address.

Updated on 18 September 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 17 September 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 17 September 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 5 September 2019 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
  • Change to section 10 - Date of revision of the text

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 therapeutic indications for the treatment of adult patients with moderately to severely active ulcerative colitis.

Updated on 5 September 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Addition of new therapeutic indications for the treatment of adult patients with moderately to severely active ulcerative colitis.

Updated on 16 January 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 January 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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 addition of paragraph on respiratory reactions (allergic alveolitis and eosinophilic pneumonia).

Section 4.8 addition of ADRs allergic alveolitis and eosinophilic pneumonia under frequency rare.

Updated on 23 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 22 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 22 August 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 22 March 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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: addition of traceability statement for biological medicinal products

Section 4.8: addition of statement “no new safety concerns were identified with up to 2 years of treatment in patients with Crohn’s Disease”; reporting of suspected adverse reactions – addition of Google Play and Apple App Store for MHRA Yellow Card

Section 5.1: addition of IM-UNITI study extension data

Section 6.3: shelf life extension for pre-filled syringe presentations to 3 years

Updated on 22 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 17 October 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.8: addition of ADR lower respiratory tract infection under frequency “uncommon”

Updated on 11 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 October 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 November 2016 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
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 November 2016 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 24 June 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 25 November 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 17 April 2014 PIL

Reasons for updating

  • Change to date of revision
  • Changes to therapeutic indications

Updated on 25 February 2014 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 17 December 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 1 October 2013 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 28 August 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 14 February 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 8 June 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 2 March 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 27 January 2012 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects

Updated on 13 January 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 3 September 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 1 September 2010 PIL

Reasons for updating

  • New PIL for new product