Isentress 600 mg tablets

Product Information *

  • Company:

    MSD Ireland (Human Health) Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 July 2021

File name

ISENTRESS-H-0860-PSUSA-00010373-202009-SPC-600-IE-en-CRT_1626789316.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_1626789156.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_1617878856.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)_1604673263.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)_1604673016.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_1559814565.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_1559814794.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_1551446549.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_1542786155.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_1542785899.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)_1540197030.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.
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

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

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)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 06 November 2017

File name

PIL_17345_521.pdf

Reasons for updating

  • New PIL for new product