Ondexxya 200 mg powder for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC
  • Status:

    No Recent Update
  • Legal 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