Opsumit 10mg
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
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
Updated on 03 October 2024
File name
EN_Opsumit 10mg_IE_SmPC_20240919_X-051G_clean-Approved (1).pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/002697/X/051/G: Paediatric Indication and Extension Application
Grouped application of:
- An Extension Application of marketing authorization to add age-appropriate formulation, 2.5mg dispersible tablets.
- A Type II C.I.6.a variation to update the EU-PI of OPSUMIT to extend the indication to the paediatric population age from 2 years to less than 18 years of age.
Updated on 03 October 2024
File name
EN_Opsumit 10mg_IE_PIL_20240919_X-051G_clean-Approved (1).pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
EMEA/H/C/002697/X/051/G: Paediatric Indication and Extension Application
Grouped application of:
- An Extension Application of marketing authorization to add age-appropriate formulation, 2.5mg dispersible tablets.
- A Type II C.I.6.a variation to update the EU-PI of OPSUMIT to extend the indication to the paediatric population age from 2 years to less than 18 years of age.
File name
Opsumit Risk Management Materials IE - Patient Alert Card.pdf
Reasons for updating
- Add New Doc
File name
Opsumit - RMM - HCP Cover letter - April 23 Update (2).pdf
Reasons for updating
- Add New Doc
Updated on 11 January 2023
File name
NI and IE Opsumit SmPC CCDS v14 - clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 January 2023
File name
NI and IE Opsumit PIL CCDS v14 - clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 26 July 2022
File name
NI and IE Opsumit SmPC C07 20Jul2022 Clean .pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 May 2022
File name
NI and IE Opsumit SmPC C06 28April2022 Clean.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 May 2022
File name
NI and IE Opsumit PIL C05 28April2022 Clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 20 May 2022
File name
ROI and IE Opsumit SmPC C06 28Apr2022 Clean.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 May 2022
File name
ROI and IE Opsumit PIL C05 28Apr2022 Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 22 February 2022
File name
ROI and IE Opsumit SmPC C05 23Feb22 Clean EDMS-RIM-665776.pdf
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)
Updated on 22 February 2022
File name
ROI and IE Opsumit PIL C04 23Feb22 Clean EDMS-RIM-665780.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 19 May 2021
File name
NI and IE Opsumit SmPC C04 19May21 Clean EDMS-ERI-205905240 V23.pdf
Reasons for updating
- 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 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
Updated to add information on drug-drug Interaction with dual moderate inhibitors of CYP3A4 and CYP2C9.
Updated on 19 May 2021
File name
NI and IE Opsumit PIL C03 19May21 Clean EDMS-ERI-205905240 V23.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Updated to add information on drug-drug Interaction with dual moderate inhibitors of CYP3A4 and CYP2C9. Plus change in local representatives
Updated on 18 March 2021
File name
NI and IE Opsumit PIL C02 12March21 Clean EDMS-ERI-205905240 V21.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Removal of bottle presentation, change to manufacturer (batch release site), change to local representatives in UK (Norther Ireland).
Updated on 18 March 2021
File name
NI and IE Opsumit SmPC C03 12March21 Clean EDMS-ERI-205905240 V21.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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
Removal of bottle presentation which was not marketed in Ireland.
Updated on 23 April 2020
File name
Opsumit SmPC C02 CHMP 17 April 2020 clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Section 4.5 updated to introduce results from the Drug-Drug Interaction studies (DDI) with Riociguat and Rosuvastatin. Plus correcting typographical errors across SmPC.
Updated on 04 March 2020
File name
Opsumit SmPC C01 CHMP 26 Feb 2020 clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- 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
Editorial changes.
Updated on 04 March 2020
File name
Opsumit PIL C01 CHMP 26 Feb 2020 clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Change in manufacturing site responsible for batch release.
File name
Opsumit Cover Letter ROI Jan 2019_.pdf
Reasons for updating
- Add New Doc
File name
Opsumit Patient Alert Card .pdf
Reasons for updating
- Add New Doc
Updated on 06 December 2018
File name
EN_Opsumit-H-2697_Notification61(3)_clean_AppV_PI-I-III-21November2018 PIL.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Updated on 05 October 2018
File name
EN_Opsumit-H-2697-renewal+MAH transfer_AppV_PI-I-III_clean_28September2018 PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 05 October 2018
File name
EN_Opsumit-H-2697-renewal+MAH transfer_AppV_PI-I-III_clean_28September2018 SPC.pdf
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 4.7 - 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 6.5 - Nature and contents of container
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 18 September 2018
File name
Opsumit 10 mg PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 17 September 2018
File name
Opsumit 10 mg SmPC.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 4.8 - Undesirable effects
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2018
File name
PIL_15920_583.pdf
Reasons for updating
- New PIL for new product
Updated on 22 February 2018
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
Updated on 18 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 January 2017
Reasons for updating
- 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
Updated on 17 January 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 October 2016
Reasons for updating
- 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 12 October 2016
Reasons for updating
- Change to name of manufacturer
Updated on 17 March 2016
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
Updated on 09 March 2016
Reasons for updating
- 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
Updated on 09 March 2016
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 08 March 2016
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 October 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 04 August 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 August 2015
Reasons for updating
- Change to date of revision
Updated on 28 July 2015
Reasons for updating
- 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 24 June 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
Updated on 23 June 2015
Reasons for updating
- Change to side-effects
Updated on 28 April 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
Updated on 22 April 2015
Reasons for updating
- Change to side-effects
Updated on 25 June 2014
Reasons for updating
- 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 20 June 2014
Reasons for updating
- Change to date of revision
Updated on 07 January 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 03 January 2014
Reasons for updating
- New PIL for new product