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
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)