Giotrif 20 mg film-coated tablets
- Name:
Giotrif 20 mg film-coated tablets
- Company:
Boehringer Ingelheim 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: 29/09/20
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Boehringer Ingelheim 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 29 September 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 January 2020 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 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 20 January 2020 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 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 2 August 2018 SPC
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 PIL
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 5 June 2018 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 24 August 2017 PIL
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 SPC
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
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 23 August 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 31 March 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 30 March 2017 SPC
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 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
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 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Improved presentation of PIL
Updated on 17 November 2016 PIL
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 SPC
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 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 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
The date of revision has also been amended to algin with the date of positive opinion.
Updated on 13 October 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 21 April 2016 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 12 April 2016 SPC
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 SPC
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 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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 23 October 2015 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
Updated on 8 September 2015 SPC
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
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 9 December 2014 PIL
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 PIL
Reasons for updating
- PIL re-instated
Updated on 20 January 2014 SPC
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
Updated on 8 November 2013 SPC
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
Updated on 8 November 2013 PIL
Reasons for updating
- New PIL for new product
- Presentation currently not marketed.