IMJUDO 20 mg/ml concentrate for solution for infusion
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
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 18 December 2024
File name
20241211 Package leaflet IE MT Imjudo Polysorbate update ONC 24 0022.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL updated to reflect changes in:
Section 2: Addition of information for Polysorbate 80, in line with the latest revision of the Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'.
Section 4: Alignment with the SmPC frequency catagorisation
Section 6: Deletion of UK (NI) from the list of local representatives in line with QRD template 10.4
Updated on 10 July 2024
File name
20240704 SPC IE MT Imjudo Pancreatic failure and Coeliac PRAC ONC 24 0016.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 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
The following sections of SmPC is updated :
Table 3. Adverse reactions in patients treated with tremelimumab in combination with durvalumab
Inclusion of Coeliac disease as rare event
Immune checkpoint inhibitor class effects
There have been cases of the following adverse reactions reported during treatment with other immune checkpoint inhibitors which might also occur during treatment with tremelimumab: pancreatic exocrine insufficiency.
Removal of NI details from AE reporting.
Updated on 10 July 2024
File name
20240704 Package leaflet IE MT Imjudo Pancreatic failure and Coeliac PRAC ONC 24 0017.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 - date of revision
Free text change information supplied by the pharmaceutical company
Update section 4 of leaflet with following text:
Rare (may affect up to 1 in 1,000 people)
-coeliac disease (characterized by symptoms such as stomach pain, diarrhoea, and bloating after consuming gluten-containing foods)
Other side effects with frequency unknown:
· lack or reduction of digestive enzymes made by the pancreas (pancreatic exocrine insufficiency)
Removing NI details from AE reporting
Updated on 17 June 2024
File name
20240527 SPC IE MT Imjudo Corticosteroid update ONC 24 0009.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 - how to report a side effect
- 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
Summary of revisions:
Section 4.2, Posology and Method administration
- Included clarifying edits within Table 1 footnotes (i.e., references to prescribing information of specific combination therapies when used with IMFINZI/Tremelimumab, timing or method of administration).
- Removal of Corticosteroid treatment column in Table 2 and updated footnotes
Section 4.4, Special Warnings and Precautions
Relocated Corticosteroid treatment information from Table 2 within respective adverse reaction subsections.
Removal of NI details from AE reporting section.
Updated on 27 February 2024
File name
20240216 SPC IE MT Imjudo Uveitis and immune mediated arthritis ONC 24 0003.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 February 2024
File name
20240216 Package Leaflet IE MT Imjudo Uveitis and immune mediated arthritis ONC 24 0004.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 - date of revision
File name
Imjudo Patient Card.pdf
Reasons for updating
- Add New Doc
Updated on 02 January 2024
File name
20231214 SPC IE MT Imjudo Paediatric Update ONC 23 0047.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 27 September 2023
File name
20230807 Package Leaflet IE MT Imjudo Solution for Infusion 20 mg-ml Postcode update ONC 23 0035.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New package leaflet for a new product
Updated on 27 September 2023
File name
20230804 SPC IE MT Imjudo Solution for Infusion 20 mg-ml HIMALAYA and POSEIDON ONC 23 0034.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New SmPC for a new product