LIBTAYO 350 mg concentrate for solution for infusion

*
Pharmacy Only: Prescription
  • Company:

    Regeneron Ireland DAC
  • 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

EDM Updated on 27 February 2024

File name

IE-NI LIBTAYO RMM - Patient Alert Card - January 2024.pdf

Reasons for updating

  • Replace File

EDM Updated on 27 February 2024

File name

IE-NI LIBTAYO RMM - Patient Guide - February 2024_dq.pdf

Reasons for updating

  • Replace File

Updated on 06 February 2024

File name

Package Leaflet (PIL text) - Libtayo - IE & NI.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 19 January 2024

File name

Package Leaflet (PIL text) - Libtayo - IE & NI.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 17 January 2024

File name

Summary of Product Characteristics (SmPC)- Libtayo IE & NI.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 17 January 2024

File name

PIL.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Sanofi local representative information replaced with Regeneron local representative information and phone numbers for Ireland, Northern Ireland, and Malta. 

Updated on 12 January 2024

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Libtayo IE & NI (3).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life

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

Updated on 12 January 2024

File name

1.3.1.3 Package Leaflet (PIL text) Libtayo (1).pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

EDM Updated on 08 November 2023

File name

8789_LIBTAYO Alert Card_IE_v4.0.pdf

Reasons for updating

  • Replace File

EDM Updated on 08 November 2023

File name

8789_LIBTAYO Patient Guide_IE_v4.0.pdf

Reasons for updating

  • Replace File

Updated on 06 July 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Libtayo (3).pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 06 July 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Libtayo IE & NI.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 22 May 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Libtayo (2).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 05 May 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Libtayo (1).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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 05 May 2023

File name

1.3.1.3 Package Leaflet (PIL text) Libtayo.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 03 April 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Libtayo.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties

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

Updated on 03 April 2023

File name

1.3.2.1 Mock-up - Package Leaflet (PIL) Libtayo.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 02 February 2023

File name

1.3.2.1 PIL Mock-up IE & UK-NI.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Updated on 25 November 2022

File name

1.3.1 SmPC - IE & UK(NI) (1).pdf

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 4.8 – Undesirable effects - how to report a side effect
  • 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)

Updated on 19 October 2022

File name

1.3.1 SmPC - IE UK(NI).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 4.8 - Undesirable effects
  • 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

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

Updated on 16 September 2022

File name

864960_Libtayo 2.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

EDM Updated on 22 August 2022

File name

LIB-2020-041_IE_RMP_Patient_Card_2022.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 22 August 2022

File name

LIB-2020-042_IE_RMP_Patient_Guide_2022.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 09 August 2022

File name

LIB-2020-041_IE_RMP_Patient_Card_2022.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 09 August 2022

File name

LIB-2020-042_IE_RMP_Patient_Guide_2022.pdf

Reasons for updating

  • Replace File

Updated on 08 July 2022

File name

1.3.1 SmPC - IE & UK(NI) (3).pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 19 January 2022

File name

Libtayo 1.3.2.1 PIL Mock-up IE & UK-NI (1).pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 14 October 2021

File name

1.3 PIL Mock-up IE UK-NI (1).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 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 14 October 2021

File name

1.3.1 SmPC - IE & UK(NI) (2).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

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

Updated on 29 June 2021

File name

1.3.1 PIL Text IE & NI.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 29 June 2021

File name

1.3.1 SmPC - IE & UK(NI) (1).pdf

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 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 5.3 - Preclinical safety data

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

Updated on 24 May 2021

File name

1.3.1 SmPC - IE & UK(NI).pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 05 May 2021

File name

1.3.1 SmPC - IE & UK(NI).pdf

Reasons for updating

  • Improved presentation of SPC

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

EDM Updated on 08 January 2021

File name

LIB-2020-042_IE_RMP_Patient_Guide 6.11.20.pdf

Reasons for updating

  • Replace File

Updated on 03 September 2020

File name

1.3 PIL Mock-up UK (3).pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 28 August 2020

File name

1.3.1 SmPC UK (1).pdf

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 07 July 2020

File name

1.3.1 SmPC UK.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

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

Updated on 07 July 2020

File name

1.3 PIL Mock-up UK (1).pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 12 June 2020

File name

1.3.1 SmPC UK.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 28 June 2019 / Renewal of the authorisation: 02 July 2020

 

 

  1. DATE OF REVISION OF THE TEXT

 

20 May 2020

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

Updated on 04 June 2020

File name

169182 (1).pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 09 December 2019

File name

Libtayo PIL.pdf

Reasons for updating

  • Improved presentation of PIL

EDM Updated on 16 October 2019

File name

LIBTAYO_RMP_Patient_Guide.pdf

Reasons for updating

  • Add New Doc

Updated on 27 September 2019

File name

SmPC.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 27 September 2019

File name

Libtayo PIL.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 August 2019

File name

Package leaflet- text IE.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 August 2019

File name

28-06-2019 SmPC IE Libtayo.pdf

Reasons for updating

  • New SPC for new product

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