Nerlynx 40 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Pierre Fabre Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 16 December 2021

File name

Nerlynx_40mg_tablet_SPC_IE_V7.0_20210902 Clean ERA study_1639670213.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_1627657028.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

EDM Updated on 12 November 2020

File name

IRE Risk Minimisation Guide for Healthcare Professionals on Diarrhoea management (2)_1605185475.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

EDM Updated on 12 November 2020

File name

Risk Minimisation Materials IRE- Patient-Carer guide how to manage diarrhoea with Nerlynx (1)_1605185268.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

EDM Updated on 12 November 2020

File name

Risk Minimisation Materials IRE - Patient Treatment Journal (1)_1605184982.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Update to telephone number

EDM Updated on 12 November 2020

File name

Risk Minimisation Material IRE - Neratinib Patient Alert Card. (1)_1605184797.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Inclusion of an additional black traingle and typographical updates.

Updated on 26 October 2020

File name

CLEAN Nerlynx_40mg_film_coated_tablets_PIL_EN_V5.0_20201015_1603712186.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_1603711899.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_1595931314.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_1594218772.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_1594218504.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

EDM Updated on 17 March 2020

File name

IRE Risk Minimisation Guide for Healthcare Professionals on Diarrhoea management (1)_1584434439.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Initial upload of the Guide for Healthcare Professionals

EDM Updated on 17 March 2020

File name

IRE Risk Minimisation Materials - Patient-Carer guide how to manage diarrhoea with Nerlynx (1)_1584434342.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Initial upload of the Patient / Carer Guide

EDM Updated on 17 March 2020

File name

IRE Risk Minimisation Materials - Patient Treatment Journal (1)_1584434283.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Initial upload of the Patient Treatment Journal

EDM Updated on 17 March 2020

File name

IRE Risk Minimisation Material - Neratinib Patient Alert Card. (1)_1584434185.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Initial upload of the Patient Alert Card

Updated on 16 March 2020

File name

Nerlynx 40mg film coated tablets SPC Ireland_1584381916.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_1584381869.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Initial upload of the PIL.