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

  • Company:

    SANOFI
  • 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 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

EDM Updated on 08 January 2021

File name

LIB-2020-041_RMP_Patient_Card_2020_IRISH 6.11.20_1610115539.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

EDM Updated on 16 October 2019

File name

LIBTAYO_RMP_Patient_Card_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)