Januvia 100mg film-coated tablets

Product Information *

  • Company:

    MSD Ireland (Human Health) Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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 01 October 2020

File name

QRD-Januvia100mg-WS1803-IE-MT-en-LFT-BRX (002).pdf_1601545438.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-MT-QRD-JANUVIA-100MG-WS1727+WS1803-PIL-en-CRT-May2020 (002).pdf_1592995467.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_1592994310.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-MT-QRD-JANUVIA 100 MG-PIL-WS-1727-CRT-Feb2020 (002.pdf)_1584618646.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

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_1584618420.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 P083

 

Updated on 18 September 2018

File name

IE_MT_QRD JANUVIA 100mg_PIL_BRX_PRO (2)_1537189827.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)_1534414722.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 100mg PIL.JAN.100mg.18.UK.6373 (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

Change to section 4.4: add Bullous pemphigoid as a warning

Updated on 10 August 2017

File name

PIL_12025_175.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 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

SPC sections which have changed: 4.2, 4.8, 5.1, 10.0

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

Change to Section 4.8 - Undesirable effects

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

To align the JANUVIA SmPC following the outcome of renewal procedure for Januvia duplicate product Ristaben (R-33)

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 31 July 2014

Reasons for updating

  • 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

Update to section 4.8 to encourage reporting of suspected adverse reactions by healthcare professionals and patients/consumers

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

None provided

Updated on 02 March 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration

Updated on 17 November 2011

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 18 January 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section

Updated on 03 September 2010

Reasons for updating

  • Change to side-effects

Updated on 12 January 2010

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 06 October 2009

Reasons for updating

  • Change to side-effects

Updated on 02 July 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 05 March 2008

Reasons for updating

  • Change to side-effects

Updated on 28 November 2007

Reasons for updating

  • Change to side-effects

Updated on 30 April 2007

Reasons for updating

  • New PIL for new product