Simponi 100 mg solution for injection, pre filled pen

  • Name:

    Simponi 100 mg solution for injection, pre filled pen

  • Company:
    info
  • Active Ingredients:

    Golimumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/03/20

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Summary of Product Characteristics last updated on medicines.ie: 13/6/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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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 10 March 2020 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Editorial and typo correction in Spanish language.

 

Updated on 17 June 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 13 June 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

SPC change details: shelf life extension and introduction of room temperature storage option

 

Updated on 9 April 2019 PIL

Reasons for updating

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

Updated on 8 April 2019 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

Change to section 4.8 – addition of “Lichenoid reactions” to Rare side effects under “Skin and subcutaneous tissue disorders”

 

Updated on 12 March 2019 PIL

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 12 March 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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

Added information on “Traceability” and “Excipients”; changed reference “Simponi” to “golimumab”; change to excipients naming convention; adverse drug reaction changed to adverse reaction

 

Updated on 31 October 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 31 October 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Change to section 4.2  & 4.4 – update the name of the Patient Reminder Card, previously called Patient Alert Card

 

Updated on 20 July 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 20 July 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic 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

Change to section 4.4  & 5.1– update the information on maintenance regimen for patients with ulcerative colitis weighing <80 kg based on analyses of PK, efficacy and safety from the pivotal C0524T18 study

Updated on 3 May 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 1 May 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

Change to section 4.4 – update of section “Haematologic reactions”;  Section 4.8 – update of side effects on section “Blood and lymphatic system disorders”

Updated on 26 April 2018 PIL

Reasons for updating

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

Updated on 22 February 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 22 February 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

SPC change details:    Change to section 4.4 – under subheading ‘Skin cancers’ - Merkel cell carcinoma has been added to the warning  about Melanoma (the same warning applies to both now),  Section 4.8 – Undesirable effects – Merkel cell cancer occurrence frequency has been changed from ‘not known’ to ‘rare’ and Change to Section 10 - Date of revision of the text has been updated.

Updated on 21 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 February 2017 PIL

Reasons for updating

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

Updated on 22 December 2016 SmPC

Reasons for updating

  • 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

Shelf-life changed from 18 months to 22 months

Updated on 25 November 2016 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic 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

SPC change details:   Sections 4.8 and section 5.1 have been updated with the results from the extension study in UC and nr Axial SpA.  PLEASE NOTE: The SPC for 100mg pre-filled pen and for 100mg pre-filled syringe have been joined with this variation update. Therefore, the number of sections now reflect the information for both 100mg presentations (pen and syringe). However, there are no changes to the text itself in any of the sections which are joint (sections 1, 2, 3, 4.4, 6.4, 6.5, 6.6 and 8).   ANOTHER NOTE:  This SPC has been uploaded twice to correct error in the Free-text which should refer to 100mg presentations in the history trail below (the SPCs for 50 mg pen and syringe are joint with this variation as well).

Updated on 24 November 2016 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic 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

SPC change details:   Sections 4.8 and section 5.1 have been updated with the results from the extension study in UC and nr Axial SpA.  PLEASE NOTE: The SPC for 50mg pre-filled pen and for 50mg pre-filled syringe have been joined with this variation update. Therefore, the number of sections now reflect the information for both 50mg presentations(pen and syringe). However, there are no changes to the text itself in any of the sections which are joint (sections 1, 2, 3, 4.4, 6.4, 6.5, 6.6 and 8).

Updated on 19 July 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic 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

A new indication - treatment of polyarticular juvenile idiopathic arthritis (pJIA) has been added to the SPC of Simponi 50mg PFP and PFS. As a consequence, sections 4.1, 4.2, 5.1 and 10 of the SPC of Simponi 100mg PFP have been updated as well.

Updated on 15 July 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 12 January 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Free text change information supplied by the pharmaceutical company

Sections that have changed:  Change to Section 4.4 - Special warnings and precautions for use, Change to Section 4.8 - Undesirable and Change to Section 10 - Date of revision of the text

SPC change details:   The SPC has been revised to:  a) Clarify that infections may present as disseminated rather than localized disease;  b)  Emphasize the risks of invasive fungal infections;  c) Clarify that leukemia has been observed in clinical trials in addition to the post-marketing setting;  d) Clarify that cases of congestive heart failure (CHF) with fatal outcomes have been observed.

 

Updated on 11 January 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 7 August 2015 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

Sections that have changed:     Change to Section 4.8 - Undesirable effects - how to report a side effect

 

SPC change details:   A new indication treatment of Non radiographic Axial SpondyloArthritis has been added recently. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SPC have been updated. The SPC that reflects these changes has been uploaded to medicines.ie on 13/07/2015. However, the correction has to be made to “Reporting of suspected adverse reactions” paragraph in section 4.8, so the SPC version uploaded in August captures this correction (there are no other changes to any other section).

Updated on 13 July 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 13 July 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 4.8 - 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

1.       Sections that have changed:     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, Change to Section 10 - Date of revision of the text

Updated on 2 June 2015 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company



Sections that have changed:  change to Section 6.3 - Shelf life, Change to Section 10 - Date of revision of the text
SPC change details:   Shelf-life changed from 1 year to 18 months and text revision date from January 2015 to May 2015

 

 

 

Updated on 23 January 2015 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • 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

Sections 9 & 10 
Reasons for submission: Approval of PSUV/058 IFU-Indicator

 

Updated on 22 January 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 6 November 2014 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

Change to Section 4.8 - Undesirable effects, Change to Section 5.1 - Pharmacodynamic properties
Approval of Type II variation to register bullous skin reactions as an uncommon adverse reaction 

Updated on 5 November 2014 PIL

Reasons for updating

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

Updated on 6 August 2014 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

Further updates to section 4.8 of SmPCs for Simponi following approval of Type II Variation - Addition of data on the long-term extension of the subcutaneous Phase 3 RA (C0524T05, C0524T06, and C0524T11), PsA (C0524T08), and AS (C0524T09) clinical studies & the provision of the final (268-week) CSRs for these 5 clinical studies to fulfill a follow-up measure and to update the SmPC regarding the frequency of certain adverse effects.

Updated on 5 August 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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 data on the long-term extension of the subcutaneous Phase 3 RA (C0524T05, C0524T06, and C0524T11), PsA (C0524T08), and AS (C0524T09) clinical studies & the provision of the final (268-week) CSRs for these 5 clinical studies to fulfill a follow-up measure and to update the SmPC regarding the frequency of certain adverse effects

Updated on 10 July 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 6.5 - Nature and contents of container
  • 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

The changes made to the SmPC are as follows:

 

Section 4.2 Posology and method of administration

‘for all of the above indications’ now precedes the 2 paragraphs on clinical response under RA, PsA and AS.

 

Section 4.8 Undesirable effects

‘within each frequency grouping, adverse reactions are presented in order of decreasing seriousness’ has been added before the table of ADRs.


Amendment of the AE reporting details to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971, Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

 

Section 5.1 Pharmacodynamic properties

‘HAQ’ has been replaced with ‘HAQ DI’

 

Section 6.5 Nature and content of container

1.0ml has been deleted from the description of type I glass: (1.0ml Type I glass)

 

Other changes have been applied throughout:

·        ‘ml’ now reads ‘mL

·        ‘medications’ have been replaced with ‘medicines

·        ‘Older people’ has been replace with ‘Elderly’

Updated on 7 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 19 March 2014 PIL

Reasons for updating

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

Updated on 4 February 2014 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

Updated on 4 February 2014 PIL

Reasons for updating

  • New PIL for new product