Ondexxya 200 mg powder for solution for infusion
*Company:
AstraZeneca Pharmaceuticals (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 19 December 2023
File name
20231211 SPC IE MT Ondexxya 200 mg Solution for Infusion Shelf Life Extension CV 23 0029.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- 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 21 June 2023
File name
20230608 SPC IE MT Ondexxya 200 mg Solution for Infusion SOB 1 & 3 CV 23 0027.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 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 21 June 2023
File name
20230608 Package Leaflet IE MT Ondexxya 200 mg Solution for Infusion SOB 1 & 3 CV 23 0026.pdf
Reasons for updating
- Change to information for healthcare professionals
- Change to date of revision
Updated on 09 June 2023
File name
20230530 SPC IE MT Ondexxya 200 mg Solution for Infusion 5 vial pack CV 23 0022.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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 09 June 2023
File name
20230530 Package Leaflet IE MT Ondexxya 200 mg Solution for Infusion 5 vial pack CV 23 0021.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 15 March 2023
File name
20230223 SPC IE MT Ondexxya 200 mg Solution for Infusion CDS Update Infusion Reactions CV 23 0013.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor administrative changes.
Updated on 15 March 2023
File name
20230223 Package Leaflet IE MT Ondexxya 200 mg Solution for Infusion CDS Update Infusion Reactions CV 23 0012.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Minor administrative changes.
Updated on 01 March 2023
File name
20230223 SPC IE MT Ondexxya 200 mg Solution for Infusion CDS Update Infusion Reactions CV 23 0008.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 01 March 2023
File name
20230223 Package Leaflet IE MT Ondexxya 200 mg Solution for Infusion CDS Update Infusion Reactions CV 23 0007.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 January 2023
File name
20230125 Package Leaflet IE MT Ondexxya 200 mg Solution for Infusion Batch Release Site Name Change CV 23 0001.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 January 2023
File name
20220607 SPC IE MT Ondexxya 200 mg Solution for Infusion MAT Alexion to AZ with SOB001 CV 22 0017.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 January 2023
File name
20220607 Package Leaflet IE MT Ondexxya MAT Alexion to AZ with SOB001 MIL CV 22 0016.pdf
Reasons for updating
- New PIL for new product