Isentress 600 mg tablets
- Name:
Isentress 600 mg tablets
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/11/20
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MSD Ireland (Human Health) Limited
Company Products
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 6 November 2020 PIL
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 6 November 2020
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
Free text change information supplied by the pharmaceutical company
Update to implement the 2017 excipient guideline
Updated on 6 June 2019 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 6 June 2019
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Update SPC to replace the reference to “Merck” logo with “MSD corporate” logo
Updated on 1 March 2019
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 SmPC
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 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 21 November 2018
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
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
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
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
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 3 May 2018
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 PIL
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 SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 26 March 2018 SPC
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 6 November 2017 SPC
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
Updated on 6 November 2017 PIL
Reasons for updating
- New PIL for new product