Giotrif 20 mg film-coated tablets

Product Information *

  • Company:

    Boehringer Ingelheim Limited
  • Status:

    Updated
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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 09 June 2021

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 29 September 2020

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 January 2020

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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 20 January 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

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: Addition of a warning statement related to GI perforation
  • Section 4.8: Addition of a new side effect ‘GI perforation’ (frequency uncommon)
  • Section 6.1: Update to excipient naming
  • Section 10: Date of revision has been updated to 28 November 2019 

Editorial update in section 4.8: The Irish AE reporting details have also been updated.

Updated on 02 August 2018

Reasons for updating

  • 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

Section updated 5.1 - Pharmacodynamic properties - To include information on EGFR TKI-naïve NSCLC patients whose tumours harbour uncommon EGFR mutations based on a meta-analysis.

Change to section 10 - Date of revision of the text.

Updated on 11 June 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to MA holder contact details
  • Removal of Black Inverted Triangle

Updated on 05 June 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 6.1 - List of excipients
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Updated on 24 August 2017

Reasons for updating

  • New PIL for new product

Updated on 24 August 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 23 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 23 August 2017

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.8 (Undesirable effects) to include ‘nail disorder’ as a side effect with common frequency.

Section 10, date of revision of the text has also been updated to align with the date of positive opinion, which was 13/07/2017.

 

Updated on 31 March 2017

Reasons for updating

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

Updated on 30 March 2017

Reasons for updating

  • 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

Update to section 5.1 (Pharmacodynamic properties) including a statement regarding acquired resistance.
Update to revision date

Updated on 13 December 2016

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

Update to section 5.1 to include efficacy data for LUX-Lung 7 plus editorial updates.
Update to section 4.8 to include a table with very common ADRs in trial LUX-Lung 7 plus editorial updates.

Section 10, date of revision of the text has been updated
Minor editorial updates to align the template with the QRD template

Updated on 22 November 2016

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Improved presentation of PIL

Updated on 17 November 2016

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings

Updated on 14 November 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update sections 4.2 and 5.2 with information relating to use of giotrif in patients with severe renal impairment.

 

In addition editorial updates have been made to sections 4.8 and 5.1.

 

Section 10, date of revision of the text has been updated

Updated on 14 October 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 have been updated with the addition of the side effect toxic epidermal necrolysis with a frequency of rare.  Also section 4.8 has been updated to revise the adverse event reporting details for Malta in order to align with the QRD template annex V.

The date of revision has also been amended to algin with the date of positive opinion.

Updated on 13 October 2016

Reasons for updating

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

Updated on 21 April 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 12 April 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company



Sections 4.1, 4.2, 4.4, 4.8 and 5.1 have been updated.

Section 10, date of revision of the text has been updated

Updated on 24 December 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

The SPC has had section 4.8 updated to include the side effect pancreatitis with frequency uncommon.

The four strengths of tablet have also been consolidated into one SPC.  The changes to sections 1, 2, 3, 6.1 and 8 are of a consequenct of this consolidation.

Updated on 18 December 2015

Reasons for updating

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

Updated on 23 October 2015

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.8 to include the side effects nausea and vomiting with frequency very common

Update to sections 4.6 and 5.2 following results of a PK sub-study in patients treated for 6 months or longer. In addition a number of minor editorial updates were made to section 5.1

Section 10, date of revision of the text has been updated

Updated on 23 October 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 08 September 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Update to section 5.1 to include clinical trial information for LUX-Lung 3 and LUX-Lung 6.
Section 4.8 has been revised to include the current address details for the HPRA.
Section 10, date of revision of the text has been updated to align with the date of positive opinion

Updated on 09 December 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 January 2014

Reasons for updating

  • PIL re-instated

Updated on 20 January 2014

Reasons for updating

  • Product/presentation re-marketed

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

Free text change information supplied by the pharmaceutical company

SPC uploaded for new product, this had previously been published on medicines.ie and retired due to delay in launch date. This document is the same as the one previously published.

Updated on 08 November 2013

Reasons for updating

  • New SPC for new product
  • Presentation currently not marketed.

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 November 2013

Reasons for updating

  • New PIL for new product
  • Presentation currently not marketed.