LIBTAYO 350 mg concentrate for solution for infusion * Pharmacy Only: Prescription
Company:
SANOFIStatus:
UpdatedLegal 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 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
Updated on 22 August 2022
File name
63035d97bd273.pdf
Reasons for updating
- Add New Doc
Updated on 22 August 2022
File name
63035d0de6849.pdf
Reasons for updating
- Add New Doc
Updated on 09 August 2022
File name
62f264418f33b.pdf
Reasons for updating
- Add New Doc
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)
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
- 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)_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
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)