Giotrif 50 mg film-coated tablets
*Company:
Boehringer Ingelheim LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 July 2023
File name
Annex PIL text - 50mg - 0041.pdf
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 29 June 2023
File name
G4-EU-SPC-16 - medicines.ie.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 6.5 - Nature and contents of container
- 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 4.2, 4.8, 5.1, 5.2 and 6.5: Updated with minor editorial changes.
Section 10 Date of revision of the SmPC has also been updated to 19 June 2023
Updated on 02 March 2023
File name
G4-EU-SPC-15.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 January 2022
File name
Annex PIL text - 50mg - 0039G.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 January 2022
File name
G4-EU-SPC-15.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.2: Paediatric Population information updated to add the following sentence “Treatment of children or adolescents with GIOTRIF was not supported by a clinical trial conducted in paediatric patients with other conditions (see sections 5.1 and 5.2). Safety and efficacy have not been established.”
- Section 5.1: Updated ATC code to “L01EB03”, editorial changes, and information regarding the paediatric study included under the sub-heading Paediatric population.
- Section 5.2: Updated to add the following paragraph
“Paediatric population
After administration of 18 mg/m2 afatinib, the steady-state exposure (AUC and Cmax) in paediatric patients aged 2 to less than 18 years was comparable to that observed in adults given 40-50 mg afatinib (see also section 4.2 for information on paediatric use).”
In addition, under the “Other information on drug-drug interactions” paragraph “OATB1B1” was changed to “OATP1B1”.
- Section 7: Updated to remove “D-” from the zip code of the address of the MAH.
- Section 10 Date of revision of the SmPC has also been updated to 13 December 2021.
Updated on 28 October 2021
File name
G4-EU-SPC-14.pdf
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections of the SmPC have been updated:
- SmPC Heading: Updated to United Kingdom (Northern Ireland), Republic of Ireland and Malta.
- Section 4.8: Updated to show AE reporting details that include “(Northern Ireland)” to the United Kingdom information, and the AE reporting details were reordered.
- Section 10 Date of revision of the SmPC has also been updated to 06 April 2021.
Updated on 09 June 2021
File name
Annex PIL text - 50mg - N-0037.pdf
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
File name
Annex PIL text - 50mg - IAIN-xxxx.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 January 2020
File name
Annex PIL text - 50mg - V0031.pdf
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 - what the product contains
- Change to section 6 - date of revision
Updated on 20 January 2020
File name
G4-ALL-SPC-13.pdf
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
File name
G4-ALL-SPC-12.pdf
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
File name
50 mg PIL 303256-09 15.05.2018 PIP028118-009 AMT 85860 cropped.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to MA holder contact details
- Removal of Black Inverted Triangle
Updated on 08 June 2018
File name
G4-ALL-SPC-11.docx
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
File name
PIL_15892_32.pdf
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
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 18 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
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 19 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 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
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
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
Updated on 08 November 2013
Reasons for updating
- New PIL for new product
- Presentation currently not marketed.