Isentress 600 mg tablets
*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 08 May 2024
File name
QRD-IE-MT-UKNI-ISENTRESS-600mg-LFT-Art61-3-108-26042024-CRT.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to further information section
Free text change information supplied by the pharmaceutical company
N/0108 - Art.61(3) to change LoLR e-mail addresses BE/LU/IE.
Updated on 04 November 2022
File name
QRD-IE-UKNI-MT-ISENTRESS 600mg PIL.IST.600mg.22.UK-NI.8296.IB-0103.RCN024405 CRT FT26Oct22.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 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 updated regarding HIV sexual and breastfeeding transmission.
Updated on 03 November 2022
File name
ISENTRESS-H-C-0860-IB-103-SPC-600mg-IE-en-CRT Oct 2022.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 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.
Section 4.5 editorial updates.
Updated on 25 May 2022
File name
QRD-IE-UKNI-ISENTRESS 600mg-LFT-BRX-NIP clean FT 20Apr22.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 600-en-CRT.pdf.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Implement updated wording related to lactation, ATC code update and editorial changes.
Updated on 02 November 2021
File name
QRD-IE-MT-ISENTRESS-600-LFT-IB-098-08102021.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 600-IE-en-CRT.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-0860-PSUSA-00010373-202009-SPC-600-IE-en-CRT.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-600 -LFT-PSUSA-202009-28062021.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-600mg-IE-en-CRT.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-600mg-IB092-LBL-102020 (002).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-600mg-IE-en (002).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 06 June 2019
File name
QRD_600mg_PIL_ISENTRESS-H-C-0860-IB-087-en-CRT.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 06 June 2019
File name
ISENTRESS-H-C-0860-IB-0087-SPC-600mg-en-CRT.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 SPC to replace the reference to “Merck” logo with “MSD corporate” logo
Updated on 01 March 2019
File name
ISENTRESS-H-C-0860-II-078-600mg-SPC-en-CRT.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
- 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
Update of section 4.5 of the SmPC to reflect the data from 3 in vitro studies evaluating the inhibitory effect of raltegravir at higher concentrations and minor editorial updates
Updated on 21 November 2018
File name
600mg_PIL_ISENTRESS-H-C-0860-II-073-PI-en-CRT.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 21 November 2018
File name
600mg_SPC_ISENTRESS-H-C-0860-II-073-PI-en-CRT.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 600mg-H-C-0860-IG-0994-SPC-IE-en-CRT (2).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_600mg_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_600mg_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
ISENTRESS600mgtabletsII064GSPCIEenCRTMar2018.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 - ISENTRESS PIL.IST.600mg.18.UK.6305.II-064G.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 26 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 26 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 (update with information regarding study PN292 (ONCEMRK);
Updated on 06 November 2017
File name
PIL_17345_521.pdf
Reasons for updating
- New PIL for new product
Updated on 06 November 2017
Reasons for updating
- New SPC for new product
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)