Simponi 100 mg solution for injection, pre filled pen
*Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
Simponi_Ed Material_Patient Reminder Card.pdf
Reasons for updating
- Add New Doc
Updated on 16 November 2023
File name
SIMPONI-H-C-0992-IB-0118-SPC-100mg-IE-en_09112023.pdf
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
Expression of the shelf-life has been amended from 24 months to 2 years. There is no actual change to the shelf-life. Some minor grammatical changes have been made throughout the SPC.
Updated on 20 July 2023
File name
QRD-IE-MT-UK(NI)-Simponi-100mg PFP-LFT-II-0109-062023.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to further information section
Updated on 26 June 2023
File name
SIMPONI-H-C-0992-II-0111-SPC-100mg-IE-en_12052023.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Update to section 4.6 of the SPC as a result of updated information on pregnancy. Editorial change to section 5.2.
Updated on 26 June 2023
File name
QRD-IE-MT-UK(NI)-Simponi-100mg PFP-LFT-II-0111-052023.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 05 April 2023
File name
SIMPONI-H-C-0992-II-107-SPC-100mg-IE-en-CRT-Feb 2023.pdf
Reasons for updating
- 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
Section 5.1 is updated to add the results of the final report from the Go-Back Study (MK-8259-038).
Updated on 17 February 2023
File name
Simponi-20201023-IE-SPC-100 mg PFS & PFP-IA-096.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC document format updated to html
Updated on 17 November 2020
File name
QRD-IE-MT-Simponi-100mg PFP-LFT-IA-096-20201023 (002).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 17 November 2020
File name
IE-Simponi-20201023-SPC-100 mg PFS PFP-IA-096 (002).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Update to the ADR table of section 4.8 (SOC Neoplasms) of the SmPC with Kaposi’s Sarcoma
Updated on 24 April 2020
File name
EN-Simponi-20200403-EUPI-IA-092-clean-SPC-IE- 100 mg PFP PFS (002).pdf.pdf
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
The following side effect has been added in the section 4.8, under skin and subcutaneous disorders: ‘Worsening of symptoms of dermatomyositis’ (frequency not known).
Updated on 21 April 2020
File name
QRD-IE-MT-PIL-Simponi 100 mg PFP-IA-092 (002).pdf.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Minor formatting updates
Change to section 4 - possible side effects (dermatomyositis)
Change to section 6 - date of revision
Updated on 10 March 2020
File name
QRD-EN-PIL-Simponi 100mg PFP-IB089 (002).pdf
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
File name
QRD-EN-PIL-Simponi 100mg PFP-II087G.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 13 June 2019
File name
EN-Simponi-20190426-EUPI-II-087-clean-SPC-IE-100 mg PFP PFS.pdf
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 09 April 2019
File name
QRD-EN-Simponi 100mg PFP-LFT-X083G+IAin088-Mar 2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 08 April 2019
File name
EN-Simponi-20190315-EUPI-IA-088-clean-SPC-IE-100mg PFP PFS.pdf
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
File name
100mg_PFP_EN-Simponi-20190218-EUPI-X-083G-clean-approved.pdf
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
File name
EN-Simponi-20190218-EUPI-X-083G-clean-SPC-IE-100mg PFP PFS.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 4.5 - 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
File name
Simponi 100mg PFP-20180906-EUPI-II-084-PIL_IE-en CRT-approved.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 31 October 2018
File name
Simponi 100mg-20180906-EUPI-II-084-SPC_IE-en CRT-approved (2).pdf
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
File name
100mg_pen_PIL_EN-Simponi-20180702-EUPI-II-079 (2).pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 20 July 2018
File name
100mg-SPC_EN-Simponi-20180702-EUPI-II-079 (2).pdf
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 03 May 2018
File name
Simponi100mgPFPPFSSPCII078CT.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 May 2018
File name
Simponi100mgPFPPFSSPCII078CT.docx
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
File name
SIMPONI PIL.SIM.100MG.PFP.18.UK.6264.II-078.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 February 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2017
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
File name
PIL_15940_45.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 December 2016
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
Updated on 25 November 2016
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
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
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
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
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
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 07 August 2015
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
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 13 July 2015
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 02 June 2015
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
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
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 06 November 2014
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 05 November 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 06 August 2014
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 05 August 2014
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
Updated on 10 July 2014
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 07 July 2014
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
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 04 February 2014
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
Updated on 04 February 2014
Reasons for updating
- New PIL for new product