Januvia 50mg film-coated tablets

  • Name:

    Januvia 50mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    sitagliptin phosphate monohydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/10/20

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Summary of Product Characteristics last updated on medicines.ie: 24/6/2020

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MSD Ireland (Human Health) Limited

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1 - 0 of 75 items.Total: Infinity pages

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 1 October 2020 PIL

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 PIL

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 PIL

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

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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 PIL

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 PIL

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

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

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 PIL

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

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 5 June 2018

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 SPC

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 10 January 2018

Reasons for updating

  • New SmPC for new product

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

Updated on 11 August 2017 SPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 August 2017 PIL

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 4 March 2016 SPC

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 6 August 2015 SPC

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 6 July 2015 SPC

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 5 May 2015 PIL

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 SPC

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 SPC

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 PIL

Reasons for updating

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

Updated on 31 July 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 11 July 2014 SPC

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 8 October 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to name of manufacturer

Updated on 20 September 2013 SPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 January 2013 SPC

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 PIL

Reasons for updating

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

Updated on 2 October 2012 SPC

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 1 October 2012 SPC

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 PIL

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 SPC

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 5 March 2012 SPC

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 2 March 2012 PIL

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)