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Isentress 25 mg /100 mg chewable tablets

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Pharmacy Only: Prescription

Updated on 08 May 2024

File name

QRD-IE-MT-ISENTRESS-25mg&100mg-LFT-Art61-3-108-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-MT-ISENTRESS-25mg&100mg-LFT-IB-103-17102022.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

ISENTRESS-H-C-0860-IB-103-SPC-25mg&100mg-IE-en-CRT Oct 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

Section 4.4 and 4.6 updated regarding HIV sexual and breastfeeding transmission.

Updated on 02 November 2021

File name

QRD-IE-MT-ISENTRESS 25 & 100 -LFT-IB-098-08102021.pdf.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 - date of revision

Updated on 02 November 2021

File name

ISENTRESS-H-C-0860-IB-098-SPC 25 & 100-IE-en-CRT Oct 2021.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 06 September 2021

File name

ISENTRESS-H-C-0860-II-093-SPC 25 100-IE-en-CRT.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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. An update to 4.2 to avoid  dividing the 100 mg tablets whenever possible.

Updated on 06 September 2021

File name

QRD-IE-MT-ISENTRESS-25 100-LFT-II-093.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 20 July 2021

File name

ISENTRESS-H-0860_PSUSA-00010373-202009-SPC-25 100-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-25100-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-25mg&100mg-IE-en-CRT.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Free text change information supplied by the pharmaceutical company

Shelf Life extension + ATC code update

Updated on 06 November 2020

File name

ISENTRESS-H-C-0860-IB-092-SPC-25mg100mg-IE-en (002).pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • 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 November 2020

File name

QRD-IE-MT-ISENTRESS-25mg100mg-IB092-LFT-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 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 06 June 2019

File name

QRD_25-100mg_PIL_ISENTRESS-H-C-0860-IB-0087-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-25mg 100mg-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-078-25mg_100mg-SPC-CRT.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

25-100mg_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

25-100mg_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 25mg_100mg-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_25_50mg_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_25_100mg_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

ISENTRESS25mg100mgchewabletabletsII064GSPCIEenCRTMar2018.docx

Reasons for updating

  • New SPC for new product

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

Updated on 01 May 2018

File name

ISENTRESS25mg100mgchewabletabletsII064GSPCIEenCRTMar2018.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.25mg+100mg.18.UK.6303.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 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 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
  • Change from individual to joint SPC

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 4.2 - update of posology; Change to section 4.5 –update of information regarding interactions; Change to section 4.6 – update of information regarding breast-feeding; Change to Section 4.8 – update of the Summary of the safety profile of the product;  10 - Update of revision of the text; editorial corrections in the text; Change from individual to joint SPC

Updated on 10 August 2017

File name

PIL_15786_718.pdf

Reasons for updating

  • New PIL for new product

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
  • Individual PILs superseded by joint PIL

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


4.2, 4.4, 4.5, 10 - Updated pharmacokinetic interaction data

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 indications (age groups) and posology

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 05 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 warnings re: co-administration with aluminium and/or magnesium antacids

Updated on 09 July 2013

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

None provided

Updated on 08 July 2013

Reasons for updating

  • New PIL for new product