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LIBTAYO 350 mg concentrate for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Cemiplimab

    This medicinal product is subject to additional monitoring.

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

Updated on 22 May 2023

File name

646b725e11e40.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 05 May 2023

File name

6454bd95b600c.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

6454bd5ea0605.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

642a9ff8ee113.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

642a9fc49d7d2.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

63dba0d931a30.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

63808bd4460c7.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

63501548d6ff1.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

632483216ebfd.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

63035d97bd273.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 22 August 2022

File name

63035d0de6849.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 09 August 2022

File name

62f264418f33b.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 09 August 2022

File name

62f263d1546bd.pdf

Reasons for updating

  • Replace File

Updated on 08 July 2022

File name

62c84c201fbe4.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)_1642606025.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)_1634219902.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)_1634219818.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_1624973837.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)_1624973760.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)_1621862135.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)_1620224491.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_1610115540.pdf

Reasons for updating

  • Replace File

Updated on 03 September 2020

File name

1.3 PIL Mock-up UK (3)_1599122064.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)_1598604182.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_1594109205.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)_1594109107.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_1591962454.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)_1591277171.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_1575908335.pdf

Reasons for updating

  • Improved presentation of PIL

EDM Updated on 16 October 2019

File name

LIBTAYO_RMP_Patient_Guide_1571225684.pdf

Reasons for updating

  • Add New Doc

Updated on 27 September 2019

File name

SmPC_1569591472.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_1569590777.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 August 2019

File name

Package leaflet- text IE_1565608077.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 August 2019

File name

28-06-2019 SmPC IE Libtayo_1565608102.pdf

Reasons for updating

  • New SPC for new product

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