Ondexxya 200 mg powder for solution for infusion * Pharmacy Only: Prescription
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 21 June 2023
File name
6492fc3a0ff5f.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
6492fa1db481b.pdf
Reasons for updating
- Change to information for healthcare professionals
- Change to date of revision
Updated on 09 June 2023
File name
6482fed229359.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
6482fcaa4ba4c.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
6411e56fe620c.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
6411e443e933f.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
63ff6739f2b28.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
63ff66ac1047d.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
63d3f5fd33c5f.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 January 2023
File name
63ce6b5699ef3.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
63ce6ab7615b9.pdf
Reasons for updating
- New PIL for new product