Nerlynx 40 mg film-coated tablets

  • Name:

    Nerlynx 40 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Neratinib Maleate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/10/20

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Summary of Product Characteristics last updated on medicines.ie: 26/10/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Pierre Fabre Limited

Pierre Fabre Limited

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Medicine Name Navelbine 20mg and 30mg Soft Capsules Active Ingredients Vinorelbine tartrate
Medicine Name Navelbine 20mg Soft Capsule Active Ingredients Vinorelbine tartrate
Medicine Name Navelbine 30mg Soft Capsule Active Ingredients Vinorelbine tartrate
Medicine Name Nerlynx 40 mg film-coated tablets Active Ingredients Neratinib Maleate
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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 26 October 2020 PIL

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 SmPC

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 PIL

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 8 July 2020 SmPC

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 8 July 2020 PIL

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

Updated on 17 March 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Initial upload of the Guide for Healthcare Professionals

Updated on 17 March 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Initial upload of the Patient / Carer Guide

Updated on 17 March 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Initial upload of the Patient Treatment Journal

Updated on 17 March 2020 Ed-Ptnt

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 SmPC

Reasons for updating

  • New SmPC 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 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Initial upload of the PIL.