Nerlynx 40 mg film-coated tablets
*Company:
Pierre Fabre 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
File name
ROI Risk Minimisation Materials - Guide for Healthcare Professionals on Diarrhoea management v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Patient-Carer guide v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Patient Treatment Journal v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Guide for Healthcare Professionals on Diarrhoea management v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Patient-Carer guide v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Patient Treatment Journal v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Guide for Healthcare Professionals on Diarrhoea management v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Patient-Carer guide v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Patient Treatment Journal v3.0.pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Patient Treatment Journal (3).pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Guide for Healthcare Professionals on Diarrhoea management (3).pdf
Reasons for updating
- Replace File
File name
ROI Risk Minimisation Materials - Patient-Carer guide (3).pdf
Reasons for updating
- Replace File
Updated on 01 June 2023
File name
Nerlynx_40mg_tablet_SPC_UK(NI)_IE_Renewal_final_clean_26.05.23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 June 2023
File name
Nerlynx_40mg_tablet_SPC_UK(NI)_IE_Renewal_final_clean_26.05.23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 June 2023
File name
Nerlynx_40mg_tablet_PIL_UK(NI)_IE_Renewal_final_clean_26.05.23.pdf
Reasons for updating
- New PIL for new product
Updated on 11 November 2022
File name
Nerlynx_40mg_tablet_SPC_UK(NI)_IE_V10_final approved_clean_10.11.22.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.2 - Posology and method of administration.
Clarification of dose modification from "Grade 0 - 1" to "Grade ≤ 1"
Clarification that fluid intake is litres per day
Update to Section 5.2 - Pharmacokinetic properties
Clarification that in vitro studies are at the relevant clinical concentration
Update to Section 10 - Date of revision of the text
Updated to reflect approval of the change
File name
ROI Risk Minimisation Materials - Patient Treatment Journal (2).pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Routine re-approval
File name
ROI Risk Minimisation Guide for Healthcare Professionals on Diarrhoea management (1).pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Routine re-approval
File name
ROI Risk Minimisation Materials - Patient-Carer guide how to manage diarrhoea with Nerlynx.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Routine re-approval
Updated on 28 April 2022
File name
Nerlynx_40mg_film_coated_tablets_PIL_UK(NI)_IE_V7.0_final approved_25.04.22.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4: Fainting added as a side effect, with frequency 'Common'.
Section 6: Revision date changed to 04/2022
Updated on 28 April 2022
File name
Nerlynx_40mg_tablet_SPC_UK(NI)_IE_V9.0_final approved_clean_25.04.22.pdf
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
Change to Section 4.8: Syncope added to Nervous System Disorders, with frequency 'Common'.
Change to Section 10: Revision date changed to 25/04/2022
Updated on 04 February 2022
File name
Nerlynx_40mg_tablet_SPC_UK(NI)_IE_V8.0_final approved_clean_24.01.22.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7: Address of MA holder updated
Section 10: Updated date of revision
Clean version attached
Updated on 04 February 2022
File name
Nerlynx_40mg_tablet_SPC_UK(NI)_IE_V8.0_final approved_clean_24.01.22 checked.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Seaction 7: Updated address of MAH
Section 10: Updated date of revision
Updated on 04 February 2022
File name
Nerlynx_40mg_film_coated_tablets_PIL_UK(NI)_IE_V6.0_final approved_24.01.22.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Change to Section 6: MAH address updated
Change to Section 6: Date of revision updated
Updated on 16 December 2021
File name
Nerlynx_40mg_tablet_SPC_IE_V7.0_20210902 Clean ERA study.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated SPC to reflect the results of an Environmental Risk Assessment.
Sections 5.3 and 6.6 were updated and the approval date added in section 10.
Updated on 30 July 2021
File name
Nerlynx_40mg_tablet_SPC_IE_V6.0_20210519 Clean.pdf
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
Change to Section 4.8 - Reporting of suspected adverse reactions.
Deletion of the references to UK reporting
Change to Section 5.1 - Pharmacodynamic properties.
Deletion of other antineoplastic agents from the pharmacotherapeutic group.
Update to the ATC code.
Change to Section 10 Date of Revsion of the Text
Date update to reflect the change
File name
IRE Risk Minimisation Guide for Healthcare Professionals on Diarrhoea management (2).pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Addition of hyperlinks to SPC and Patient Information.
Update to the telephone number
File name
Risk Minimisation Materials IRE- Patient-Carer guide how to manage diarrhoea with Nerlynx (1).pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to the telphone number.
Inclusion of pomegranate juice as a product to avoid.
Inclusion of a hyperlink to the Patient Information.
Update to the SIgns and symptoms
File name
Risk Minimisation Materials IRE - Patient Treatment Journal (1).pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update to telephone number
Updated on 26 October 2020
File name
CLEAN Nerlynx_40mg_film_coated_tablets_PIL_EN_V5.0_20201015.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Inclusion of details for hormone receptor positive (HR-positive) patients
Updated on 26 October 2020
File name
CLEAN Nerlynx_40mg_film_coated_tablets_SPC_EN_V5.0_20201015.pdf
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 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
Sections 4.2, 4.4, 4.5 are corrections to minor typographical errors and to improve the readability.
Sections 5.1 and 5.2 have been updated in order to include final OS results from study 3144A2-3004-WW, a randomised, double-blind, placebo-controlled trial of neratinib after trastuzumab in women with early-stage HER-2/neu overexpressed/amplified breast cancer.
Updated on 28 July 2020
File name
Nerlynx_40mg_film_coated_tablets_PIL_EN_V4.0_20200716.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to Section 2:
Deletion of Phenobarbital
Updated on 08 July 2020
File name
Nerlynx_40mg_film_coated_tablets_SPC_EN_V4.0_20200625.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
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 - Changes to dose modifications.
Section 4.3 - Improved cross references to other sections.
Section 4.4 - Changes to special warnings on Proton pump inhibitors and concomitant treatments
Section 4.5 - Major changes to the whole section.
Section 5.1 - Rounding of the median age for the intention to treat population from 52.3 years to 52 years and update to data concerning hormone receptor positive patients.
Section 5.2 - Major changes to pharmacokinetic properties.
Updated on 08 July 2020
File name
Nerlynx_40mg_film_coated_tablets_PIL_EN_V3.0_20200625.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2: Do not take Nerlynx.
- Updates to the list of products
Section 2: Other medicines and Nerlynx
- Updates to the list of medicines
Section 2: Nerlynx with food and drink
- Addition of pomegranate
Section 6: Date of revision
- Updated to reflect approval of the change
File name
IRE Risk Minimisation Guide for Healthcare Professionals on Diarrhoea management (1).pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Initial upload of the Guide for Healthcare Professionals
File name
IRE Risk Minimisation Materials - Patient-Carer guide how to manage diarrhoea with Nerlynx (1).pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Initial upload of the Patient / Carer Guide
File name
IRE Risk Minimisation Materials - Patient Treatment Journal (1).pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Initial upload of the Patient Treatment Journal
Updated on 16 March 2020
File name
Nerlynx 40mg film coated tablets SPC Ireland.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Initial upload of the SmPC.
Updated on 16 March 2020
File name
Nerlynx 40mg film coated tablets PIL Ireland.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Initial upload of the PIL.