LIBTAYO 350 mg concentrate for solution for infusion
*Company:
Regeneron Ireland DACStatus:
No Recent UpdateLegal 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
Updated on 17 October 2024
File name
Summary of Product Characteristics (SmPC)- Libtayo IE & NI - paediatric label update - Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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)
Updated on 24 July 2024
File name
Package Leaflet (PIL text) - Libtayo - IE & NI - Uveitis_BCC - Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 July 2024
File name
Summary of Product Characteristics (SmPC)- Libtayo IE & NI - Uveitis_BCC - Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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)
Updated on 20 June 2024
File name
Package Leaflet (PIL text) - Libtayo - IE & NI - PRAC CD & PI - Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 June 2024
File name
Summary of Product Characteristics (SmPC)- Libtayo IE & NI - PRAC CD & PI - Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
IE-NI LIBTAYO RMM - Patient Alert Card - January 2024.pdf
Reasons for updating
- Replace File
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
File name
8789_LIBTAYO Alert Card_IE_v4.0.pdf
Reasons for updating
- Replace File
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
File name
LIB-2020-041_IE_RMP_Patient_Card_2022.pdf
Reasons for updating
- Add New Doc
File name
LIB-2020-042_IE_RMP_Patient_Guide_2022.pdf
Reasons for updating
- Add New Doc
File name
LIB-2020-041_IE_RMP_Patient_Card_2022.pdf
Reasons for updating
- Add New Doc
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)
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
- DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28 June 2019 / Renewal of the authorisation: 02 July 2020
- 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
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)