Isentress 400 mg tablets * Pharmacy Only: Prescription
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
Updated on 04 November 2022
File name
6364e91558743.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 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 updated regarding HIV sexual and breastfeeding transmission and editorial updates in section 6.
Updated on 03 November 2022
File name
6363d5a00d29b.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
Section 4.4 and 4.6 updated regarding HIV sexual and breastfeeding transmission.
Updated on 27 July 2022
File name
62e138a2e2b72.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL
Updated on 02 November 2021
File name
ISENTRESS-H-C-0860-IB-098-SPC 400-en-CRT.pdf_1635862549.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- 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
Align the desiccant wording with other Isentress strengths, implement updated wording related to lactation, ATC code update and editorial changes.
Updated on 02 November 2021
File name
QRD-IE-MT-ISENTRESS 400-LFT-IB-098-08102021_1635861074.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
Updated on 06 September 2021
File name
ISENTRESS-H-C-0860-II-093-SPC 400-IE-en-CRT_1630923790.pdf
Reasons for updating
- 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 safety information following pregnancy outcome data for 400 mg FCT from prospective reports of pregnancy data with known outcome and time of raltegravir exposure.
Updated on 20 July 2021
File name
ISENTRESS-H-C-0860_PSUSA-00010373-202009-SPC-400-IE-en-CRT_1626788425.pdf
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
Update to include a risk of a DDI with iron salts and a recommendation to stagger administration.
Updated on 20 July 2021
File name
QRD-IE-MT-ISENTRESS-400-LFT-PSUSA-202009 -28062021_1626788264.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 08 April 2021
File name
ISENTRESS-H-C-0860-IB-095-G-SPC-400mg-IE-en-CRT_1617878759.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
ATC code update
Updated on 06 November 2020
File name
QRD-IE-MT-ISENTRESS-400mg-IB092-LFT-102020.pdf_1604671964.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 06 November 2020
File name
ISENTRESS-H-C-0860-IB-092-SPC-400mg-IE-en.pdf_1604671523.pdf
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
- 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
Update to implement the 2017 excipient guideline
Updated on 24 July 2019
File name
QRD_400mg_PIL_ISENTRESS-H-C-0860-IB-087-en-CRT (002)_1563964668.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 23 July 2019
File name
IE-ELOCON_LOTION-EN-SPC-20170912-CRT(002)_1561626529_1563875174.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 16 July 2019
File name
QRD_400mg_PIL_ISENTRESS-H-C-0860-IB-087-en-CRT (002)_1563279286.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 01 March 2019
File name
ISENTRESS-H-C-0860-II-078-400mg-SPC-en-CRT_1551446081.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC
Change to section 10 - Date of revision of the text
Editorial updates
Updated on 21 November 2018
File name
400mg_PIL_ISENTRESS-H-C-0860-II-073-PI-en-CRT_1542786436.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 21 November 2018
File name
400mg_SPC_ISENTRESS-H-C-0860-II-073-PI-en-CRT_1542786551.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)
Free text change information supplied by the pharmaceutical company
Change to section 4.6 & 5.3 (update regarding pregnancy and risk of malformative or foetal toxicity (LEG)
Updated on 22 October 2018
File name
ISENTRESS 400mg-H-C-0860-IG-0994-SPC-IE-en-CRT (2)_1540197322.pdf
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
Change to section 4.4 & Change to section 4.8: addition of "autoimmune hepatitis”
Updated on 26 June 2018
File name
SPC_400mg_ISENTRESS-H-C-0860-T-075-PI-en-CRT (2).docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 7 - Marketing authorisation holder
|
Present |
Proposed |
|
Merck Sharp & Dohme Ltd. |
Merck Sharp & Dohme B.V. |
Updated on 26 June 2018
File name
PIL_400mg_ISENTRESS-H-C-0860-T-075-PI-en-CRT (2).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 May 2018
File name
ISENTRESS400mgtabletsII064GSPCIEenCRTMar2018.docx
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 5.2 - Pharmacokinetic properties
- 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
Change to section 4.1 (update regarding Paediatric population) Change to section 4.2 (update regarding Paediatric population); Change to Section 4.8 (update the safety information); Change to section 5.2 (update regarding Paediatric population)
Updated on 24 April 2018
File name
QRD_PIL.IST.400mg.18.UK.6304.II-064G (2).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 27 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 March 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
- 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
Change to Section 4.8 (update the safety information); Change to section 5.1 (editorial corrections);
Updated on 06 November 2017
File name
PIL_12801_414.pdf
Reasons for updating
- New PIL for new product
Updated on 06 November 2017
Reasons for updating
- 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
Change to section 6.5: add the term “multipack”
Updated on 06 November 2017
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 11 August 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.8 – Undesirable effects - how to report a side effect
- 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
Updated on 10 August 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 December 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
SPC change details: Minor formatting changes to tables
Updated on 21 January 2015
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 4.5 - 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 04 September 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- 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 June 2014
Reasons for updating
- Change to warnings or special precautions for use
- Addition of information on reporting a side effect.
Updated on 03 June 2014
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- 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
Changes to Sections: 2, 4.2, 4.4, 4.5, 4.8, 6.6, 10
Updated interactions (Effect on pharmacokinetics of boceprevir)
Updated on 13 September 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 06 September 2013
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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Updated on 03 July 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 14 June 2013
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
- 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 sections have changed: 4.4, 4.5, 4.8, 10 - Updated warnings re: autoimmune disorders; interactions with boceprevir
Updated on 08 April 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
Updated on 06 March 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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
Following SPC sections have changed: 2, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 10.
Added paediatric indication; updated interactions (omeprazole and famotidine); updated fertility, pregnancy and lacation information; updated side effects
Updated on 11 January 2013
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
SPC sections: 4.5, 10 - Updated pharmacokinetics for raltegravir and darunavir
Updated on 10 January 2013
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 03 December 2012
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)
Free text change information supplied by the pharmaceutical company
Detailed SPC change information: Added reference to hepatic failure (uncommon)
Updated on 12 September 2012
Reasons for updating
- Change to further information section
Updated on 24 August 2012
Reasons for updating
- Change to section 5.2 - Pharmacokinetic 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 10 April 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
Updated on 04 April 2012
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
Sections 4.4 (Special warnings and precautions for use
)
Added warning on depression
Updated on 29 February 2012
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
Sections 4.8 (
Undesirable effects), 5.1 (Pharmacodynamic properties)
Added side effects / modified side effect frequencies.
Updated on 16 January 2012
Reasons for updating
- Change to side-effects
Updated on 07 December 2011
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)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 updated
Added warnings for Severe skin and hypersensitivity reactions and updated uncommon side effects
Updated on 24 November 2010
Reasons for updating
- Change to side-effects
Updated on 22 September 2010
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 & 10
4.8 The update concerns the addition of the terms "rhabdomyolysis" and "thrombocytopenia" in section 4.8 of the SPC based upon post-marketing reports. The frequency category of the ADRs identified in the post-marketing period "Stevens-Johnson Syndrome" and "Suicidal ideation and suicidal behaviour" is changed from "not known" to "uncommon
10 - Amend date of revision
Updated on 17 May 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 21 April 2010
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 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
To include additional clinical data (96 weeks data)
Section 4.1, 4.4, 4.8, 5.1 and 10 have changed
Section 4.1, 4.4, 4.8, 5.1 and 10Updated on 06 October 2009
Reasons for updating
- Change to side-effects
- Changes to therapeutic indications
Updated on 02 October 2009
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.3 - Preclinical safety data
- 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
Updated on 12 August 2009
Reasons for updating
- Change to side-effects
Updated on 10 June 2009
Reasons for updating
- 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
Update to Section 5.3 Preclinical safety data.
Updated on 20 May 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
- 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
To add the following to section 4.8:
suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness).
Updated on 15 May 2009
Reasons for updating
- Change to side-effects
Updated on 28 January 2009
Reasons for updating
- Improved electronic presentation
Updated on 20 January 2009
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 8 - MA number
- 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
Changes are to Sections 4.1, 4.5, 4.8, 5.1, 8 & 10.
Updated on 08 September 2008
Reasons for updating
- Change to side-effects
Updated on 05 September 2008
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
Changes are to Section 4.8 and 10.
Updated on 31 January 2008
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 January 2008
Reasons for updating
- New PIL for new product