Januvia film-coated tablets
*Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 October 2023
File name
JANUVIA-H-C-0722-WS-2545-G-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of “propyl gallate” to section 6.1 (List of excipients) of the SmPC
Reduction of the shelf life of the finished product, from “3 years” to “2 years” in section 6.3 (Shelf life) of the SmPC
Change in storage conditions of the finished product, from "This medicinal product does not require any special storage conditions" to "Store below 25 °C" in section 6.4 (Special precautions for storage) of the SmPC.
Updated on 02 October 2023
File name
QRD-IE-MT-UKNI-JANUVIA -LFT-PACMP CRT.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 30 January 2023
File name
JANUVIA-H-C-0722-WS-2091-SPC-IE-en-Sept 2021.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC document format updated to html.
Updated on 11 July 2022
File name
QRD-IE-MT-UKNI-JANUVIA -LFT-BRX-NIP clean Final 24Mar22.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 04 October 2021
File name
JANUVIA-H-C-0722-WS-2091-SPC-IE-en-September 2021.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Formatting changes only in sections 2.0, 3.0 and 8.0 and a new date of revision.
Updated on 04 October 2021
File name
QRD-IE-MT-JANUVIA-LFT-WS-2091-CRT-16092021.pdf
Reasons for updating
- Change to section 6 - what the product contains
- 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
Individual PILs superseded by joint PIL.
Updated on 01 October 2020
File name
IE-QRD-JANUVIA-25MG-WS1727+WS1803-PIL-en-Haarlem-Sept 2020 (002).pdf.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Update QP release stated in leaflet to Haarlem
Updated on 24 June 2020
File name
IE-QRD-JANUVIA-25MG-WS1727+WS1803-PIL-en-CRT-May2020 (002).pdf.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Leaflet updated to include the results from WS1803, to provide data on the sodium content per tablet in section 2.0
Updated on 24 June 2020
File name
JANUVIA-H-C-0722-WS-1803-SPC-IE-en-CRT-May2020 (002).pdf.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC updated to include the results from WS1803, to provide data on the sodium content per tablet in section 4.4.
Updated on 19 March 2020
File name
IE-QRD-JANUVIA-25 MG-PIL-WS-1727-en-CRT-Feb2020 (002.pdf).pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Had to uploaded PIL again due to technical error
Updated on 19 March 2020
File name
IE-QRD-JANUVIA-25 MG-PIL-WS-1727-en-CRT-Feb2020 (002).
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL Change Details: Use in children and adolescents has been updated with paediatric study P083 results
Updated on 19 March 2020
File name
JANUVIA-H-C-0722-WS-1727-SPC-IE-en-CRT-Feb2020 (002).pdf.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC Change Details: SPC updated to include the data from paediatric study P083SPC
Updated on 18 September 2018
File name
IE_QRD_JANUVIA 25mg PIL.Januvia_BRX_PRO (2).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 16 August 2018
File name
JANUVIA-H-C-0722-T-065-SPC-IE-en-CRT-August 2018 (2).pdf
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
The Marketing Authorisation holder has changed from Merck Sharp & Dohme Ltd UK to Merck Sharp & Dohme B.V. The Netherlands as a result of Brexit
Updated on 20 June 2018
File name
QRD JANUVIA 25mg PIL.JAN.25mg.18.UK.6371 (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 June 2018
File name
JANUVIA-H-C-0722-PSUSA-2711-201708-SPC-IE-en-CRT-May2018.docx
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.8 - Undesirable effects; Change to Section 10 - Date of revision of the text
Thrombocytopenia is being added under the ‘Blood and lymphatic system’ disorders with a frequency ‘rare’.
Updated on 10 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 January 2018
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 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to section 4.2, 4.4, 5.2 &10.0 in order to redefine mild, moderate, and severe renal impairment based on eGFR instead of CrCl.
Updated on 11 August 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 09 August 2017
File name
PIL_15281_712.pdf
Reasons for updating
- New PIL for new product
Updated on 09 August 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 March 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Reasons for submission: Type II, TECOS cardiovascular safety study (WS846)
Updated on 13 August 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 06 August 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Detailed SPC change information:
Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties
Change to Section 9 - Date of renewal of authorisation
Change to Section 10 - Date of revision of the text
Reasons for submission: Approval of WS741 (addition of pruritus to side effects)
Updated on 06 July 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 05 May 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to dosage and administration
Updated on 13 April 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 November 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
ChanChange to Section 4.4 - Special warnings and precautions for use to update the product information that the use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis
Updated on 20 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 05 August 2014
Reasons for updating
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 11 July 2014
Reasons for updating
- 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 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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 6.5 - Nature and contents of container
Updated on 08 October 2013
Reasons for updating
- Change to side-effects
- Change to name of manufacturer
Updated on 20 September 2013
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 31 January 2013
Reasons for updating
- Change to side-effects
Updated on 30 January 2013
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties
Updated on 19 October 2012
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 02 October 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties
Updated on 01 October 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties
Updated on 25 April 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to dosage and administration
- Change to MA holder contact details
Updated on 10 April 2012
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section: 4.6, 4.7, 4.8, 4.9 and 5.1.
Detailed SPC change information: Updated with results of renewal changes.
Updated on 05 March 2012
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 02 March 2012
Reasons for updating
- New individual PIL (was previously included in a combined PIL)