Odefsey 200 mg/25 mg/25 mg film-coated tablets
*Company:
Gilead Sciences LtdStatus:
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 28 February 2023
File name
Odefsey SmPC film coated tablets XI&IE (February 2023).pdf
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)
Updated on 28 February 2023
File name
Odefsey PIL film coated tablets XI&IE (February 2023).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 23 November 2022
File name
Odefsey SmPC film coated tablets XI&IE (November 2022).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 4.4 and 4.6 to update wording related to the risk of HIV transmission and the removal of the disease information relating to sexual transmission of HIV and amendment of the sections relating to breast-feeding.
Updated on 23 November 2022
File name
Odefsey PIL film coated tablets XI&IE (November 2022).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
To update wording in section 2 related to the risk of HIV transmission - removal of the disease information relating to sexual transmission of HIV and amendment of the sections relating to breast-feeding. Also update the contact details of the local representative listed in the Package Leaflet for Estonia, Latvia, Lithuania and Romania.
Updated on 01 June 2021
File name
Odefsey SmPC IE&XI (May 2021).pdf
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
Update the nephrotoxicity information (Section 4.4 of the Summary of Product Characteristics [SmPC])
Updated on 01 June 2021
File name
Odefsey PIL XI&IE (May 2021).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 26 January 2021
File name
Odefsey SmPC - January 2021.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 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- 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
Approval of Renewal of the Marketing Authorisation (MA) of Odefsey with the following points:
- Renewal approved with unlimited validity.
- Based on the review of quality, safety and efficacy data, including all variations introduced since the Marketing Authorisation was granted, the risk-benefit balance of Odefsey remains unchanged.
- Renewal approved with updates to the Odefsey product information (in particular to SmPC sections 2, 4.2, 4.4, 4.7, 4.8). Gilead also took this opportunity to implement administrative updates throughout the Odefsey product information.
Furthermore, the approval also includes endorsement to remove the black triangle status which means that additional safety monitoring of Odefsey is no longer required.
Gilead also took the opportunity to formally close-out the following post-authorisation measure (PAM; Recommendation), adopted as part of the initial MA:
- to provide a review of the literature for information on the ability of new HIV or HCV protease inhibitors to inhibit cathepsin A (CatA)’
With this approval, this Recommendation has been fulfilled.
Updated on 26 January 2021
File name
Odefsey PIL - January 2021.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Approval of Renewal of the Marketing Authorisation (MA) of Odefsey with the following points:
- Renewal approved with unlimited validity.
- Based on the review of quality, safety and efficacy data, including all variations introduced since the Marketing Authorisation was granted, the risk-benefit balance of Odefsey remains unchanged.
- Renewal approved with updates to the Odefsey product information ([PIL] section 3). Gilead also took this opportunity to implement administrative updates throughout the Odefsey product information.
Furthermore, the approval also includes endorsement to remove the black triangle status which means that additional safety monitoring of Odefsey is no longer required.
Gilead also took the opportunity to formally close-out the following post-authorisation measure (PAM; Recommendation), adopted as part of the initial MA:
- to provide a review of the literature for information on the ability of new HIV or HCV protease inhibitors to inhibit cathepsin A (CatA)’
With this approval, this Recommendation has been fulfilled.
Updated on 05 June 2020
File name
Odefsey - SmPC - April 2020.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 June 2020
File name
Odefsey - PIL - April 2020.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 29 July 2019
File name
Odefsey PIL Jun 2019.pdf
Reasons for updating
- Change to date of revision
Updated on 29 July 2019
File name
Odefsey SmPC Jun 2019.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- 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 4.9 to remove recommendation to use oral activated charcoal in the event of an overdose of rilpilvirine
Updated on 10 July 2019
File name
Odefsey PIL Jun 2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 July 2019
File name
Odefsey SmPC Jun 2019.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
update to section 4.8 to include angioedema and urticaria
Updated on 25 June 2019
File name
Odefsey PIL June 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
Updated on 25 June 2019
File name
Odefsey SmPC June 2019.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
- 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)
Updated on 19 September 2018
File name
Odefsey SmPC Sep 2018.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 June 2018
File name
Odefsey_SmPC_May2018.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Approval of MA Transfer application changing the Odefsey MA Holder (MAH) from Gilead Sciences International Ltd., Cambridge - UK (GSIL; ‘transferor’) to Gilead Sciences Ireland UC, Cork - Ireland (GSIUC; ‘transferee’) as a result of ‘BREXIT’. The full details of the new MAH is:
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
The application updates the product information annexes as follows:
- Updates to the Summary of Product Characteristics (SmPC) Section 7 (Marketing Authorisation Holder),
Updated on 05 June 2018
File name
Odefsey PIL UK IE - May 2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 02 May 2018
File name
OdefseySmPC_Apr2018.docx
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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)
Updated on 03 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 April 2018
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 03 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 January 2018
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 4.6 - Pregnancy and lactation
- 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
Updated on 26 October 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 06 September 2017
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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Updates to sections 4.4, 4.8 and 5.1 to provide 48 weeks data from Study GS-US-292-1249
- Updates to section 4.5: deletion of telaprevir DDI due to the withdrawal of telaprevir from the EU
- Updates to section 4.5 (in line with the CCDS): clarification that co-administration with other breast cancer resistance protein (BCRP) inhibitors (as well as P-glycoprotein [P-gp] inhibitors) is not expected to further increase TAF exposures . SmPC section 4.4 for DVY was also updated.
- Updates to section 4.5 (in line with the CCDS): correction of the spelling of “norelgestromin”.
- Updates to sections 4.4 and 4.5 (in line with the CCDS): added warning against the co-administration with TAF
- Updates to sections 4.6, 5.1, 5.3 and throughout as needed: correction of abbreviations and/or formatting as needed in line with the CCDS and/or EU QRD template.
Updated on 22 August 2017
File name
PIL_16814_478.pdf
Reasons for updating
- New PIL for new product
Updated on 22 August 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - manufacturer
Updated on 10 July 2017
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
Updated on 07 June 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Variation to update the product information (PI) annexes of the TDF- and TAF-containing products with data from Studies GS-US-342-1167/1326, two drug-drug interaction studies between Epclusa (sofosbuvir/velpatasvir; SOF/VEL) and HIV antiretroviral regimens. Sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC) and Section 2 of the Patient Information Leaflet (PIL) have been updated for Viread (all strengths), Truvada, Stribild and Atripla. Section 4.5 of the SmPC has been updated for Eviplera, Genvoya, Descovy and Odefsey.
Note, an administrative edit has been done in Section 4.8 of the SmPC for Viread for all strengths, Stribild, Atripla and Eviplera (not required for Truvada). This administrative update was required to align with the table ‘Tabulated summary of AR associated with ‘XXX’ based on clinical study and post marketing experience’.
We took the opportunity of this application to submit minor linguistics amendments
Updated on 07 April 2017
Reasons for updating
- 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 on 08 March 2017
Reasons for updating
- 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
Updated on 03 March 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 24 January 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 October 2016
Reasons for updating
- 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
Updated on 11 August 2016
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 09 August 2016
Reasons for updating
- New PIL for new product