Mounjaro
*Company:
Eli Lilly and Company (Ireland) LimitedStatus:
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 10 February 2026
File name
Mounjaro_IRMA_PIL_Jan26_IE_MT.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 1: Indication added for children and adolescents 10 years and above
Section 2: Edited to include children and adolescents 10 years and above
Section 3: Dose added for children and adolescents 10 years and above
Section 4: Updated to include children and adolescents 10 years and above
Section 6: Updated latest revision date
Other sources of information: Edit to EMA hyperlink
Updated on 10 February 2026
File name
Mounjaro_KP_PIL_Jan26_IE_MT.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 1: Indication added for children and adolescents 10 years and above
Section 2: Edited to include children and adolescents 10 years and above
Section 3: Dose added for children and adolescents 10 years and above
Section 4: Updated to include children and adolescents 10 years and above
Section 6: Updated latest revision date
Other sources of information: Edit to EMA hyperlink
Updated on 10 February 2026
File name
Mounjaro_vial_PIL_Jan26_IE_MT.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 1: Indication added for children and adolescents 10 years and above
Section 2: Edited to include children and adolescents 10 years and above
Section 3: Dose added for children and adolescents 10 years and above
Section 4: Updated to include children and adolescents 10 years and above
Section 6: Updated latest revision date
Other sources of information: Edit to EMA hyperlink
Updated on 10 February 2026
File name
Mounjaro_SmPC_Jan26_IE_MT.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.1: Paediatric T2DM New Indication added
- Section 4.2: Posology updated
- Section 4.8: Frequency of adverse reactions updated
- Section 5.1: Data added for use in children and adolescence 10 years to less than 18 years
- Section 5.2: Information added for use in children and adolescence 10 years to less than 18 years
- Section 5.3: Information added for use in children and adolescence 10 years to less than 18 years
- Section 10: Date of revision edited and edit to hyperlink for EMA website
Updated on 06 February 2026
File name
Mounjaro_IRMA_PIL_Jan26_IE_MT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
underlined= changed
6. Contents of the pack and other information
[...]
Marketing Authorisation Holder
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.
[...]
This leaflet was last revised in January 2026.
Updated on 06 February 2026
File name
Mounjaro_KP_PIL_Jan26_IE_MT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
underlined= changed
6. Contents of the pack and other information
[...]
Marketing Authorisation Holder
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.
[...]
This leaflet was last revised in January 2026.
Updated on 06 February 2026
File name
Mounjaro_vial_PIL_Jan26_IE_MT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
underlined= changed
6. Contents of the pack and other information
[...]
Marketing Authorisation Holder
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.
[...]
This leaflet was last revised in January 2026.
Updated on 06 February 2026
File name
Mounjaro_SmPC_Jan26_IE_MT.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
underlined= changed
7. MARKETING AUTHORISATION HOLDER
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.
10. DATE OF REVISION OF THE TEXT
16 January 2026
Updated on 22 December 2025
File name
Mounjaro_SmPC_Oct25_IE_MT.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 September 2025
File name
Mounjaro_Vial_PIL_MO060_Feb25_IE_MT.pdf
Reasons for updating
- XPIL Updated
Updated on 05 September 2025
File name
Mounjaro_IRMA_PIL_MO059_Feb25_IE_MT.pdf
Reasons for updating
- XPIL Updated
Updated on 05 September 2025
File name
Mounjaro_KP_PIL_MO065_Mar2025_IE-MT.pdf
Reasons for updating
- XPIL Updated
Updated on 04 September 2025
File name
Mounjaro_IRMA_PIL_MO059_Feb25_IE_MT.pdf
Reasons for updating
- XPIL Created
Updated on 04 September 2025
File name
Mounjaro_KP_PIL_MO065_Mar2025_IE-MT.pdf
Reasons for updating
- XPIL Created
Updated on 04 September 2025
File name
Mounjaro_Vial_PIL_MO060_Feb25_IE_MT.pdf
Reasons for updating
- XPIL Created
Updated on 28 August 2025
File name
Mounjaro_SmPC_Jul25_IE_MT.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section 5.1 - Pharmacodynamic properties
File name
Mounjaro_KP_IFU_JUN2025_IE-MT.pdf
Reasons for updating
- Replace File
Updated on 02 April 2025
File name
Mounjaro_KP_PIL_MO065_Mar2025_IE-MT.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
File name
Mounjaro_KP_IFU_MO061_Feb25_IE_MT.pdf
Reasons for updating
- Replace File
Updated on 03 March 2025
File name
Mounjaro_Vial_PIL_MO060_Feb25_IE_MT.pdf
Reasons for updating
- New PIL for new product
Updated on 03 March 2025
File name
Mounjaro_IRMA_PIL_MO059_Feb25_IE_MT.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 03 March 2025
File name
Mounjaro_SmPC_MO057_Feb25_IE_MT.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 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 03 March 2025
File name
Mounjaro_KP_PIL_MO058_Feb25_IE_MT.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 13 January 2025
File name
Mounjaro IRMA_PIL_MO055_Dec24_IE.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 January 2025
File name
Mounjaro KP_PIL MO054_Dec24_IE.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 January 2025
File name
Mounjaro_SmPC_MO053_Dec24_IE.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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)
File name
Mounjaro KP_IFU_MO046_Sep_24_IE.pdf
Reasons for updating
- Replace File
File name
Mounjaro IRMA_IFU_MO045__Sep24_IE.pdf
Reasons for updating
- Replace File
Updated on 11 October 2024
File name
Mounjaro KP_PIL MO043_Sep24_IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 October 2024
File name
Mounjaro IRMA_PIL_MO044_Sep_24_IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 11 October 2024
File name
Mounjaro_SmPC_MO042_Sep24_IE.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 August 2024
File name
Mounjaro_PIL MO036_July24_IE.pdf
Reasons for updating
- Addition of manufacturer
Updated on 12 June 2024
File name
Mounjaro_PIL MO035_Jun24_IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
File name
Mounjaro_IFU_MO031_Apr24.pdf
Reasons for updating
- Replace File
File name
Mounjaro_IFU_MO033_April24_IE.pdf
Reasons for updating
- Add New Doc
Updated on 31 May 2024
File name
Mounjaro_PIL_MO032_Apr24_IE.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 31 May 2024
File name
Mounjaro_SmPC_MO034_Apr24_IE.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
adding the adverse event reporting details for HPRA
File name
Mounjaro_IFU_MO031_Apr24.pdf
Reasons for updating
- Add New Doc
Updated on 30 May 2024
File name
Mounjaro_SmPC_MO029_Apr24_IE.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- 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 30 May 2024
File name
Mounjaro_PIL_MO030_Apr24_IE.pdf
Reasons for updating
- New PIL for new product
Updated on 13 March 2024
File name
Mounjaro_SmPC_MO026_Dec23_IE.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Addition of country specific adverse events reporting details
Updated on 13 March 2024
File name
Mounjaro_PIL_MO027_Dec23_IE.pdf
Reasons for updating
- New PIL for new product
File name
Mounjaro_IFU_MO024_Dec23_IE.pdf
Reasons for updating
- Add New Doc
Updated on 12 March 2024
File name
Mounjaro_SmPC_MO022_Dec23_IE.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Eli Lilly and Company (Ireland) Limited
 Limited.webp)
Address:
Lilly House, Basing View, Basingstoke, Hampshire, RG21 4FA, United KingdomMedical Information E-mail:
ukmedinfo@lilly.comTelephone:
+353 1 661 4377Website:
https://www.lilly.ie