Qdenga powder and solvent for solution for injection in pre-filled syringe
*Company:
Takeda Products Ireland LtdStatus:
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 05 November 2024
File name
ie-ni-spc-qdenga-clean-anaphylaxis-2024.10.31.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)
Free text change information supplied by the pharmaceutical company
Anaphylaxis has been added as an adverse event.
Updated on 05 November 2024
File name
ie-ni-pl-qdenga-vial-pfs-clean-anaphylaxis-2024.10.31.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Anaphylaxis has been added as an adverse event
Updated on 23 October 2024
File name
ie-ni-spc-qdenga-clean-shelf-life-ext-24.10.23.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 September 2024
File name
ie-ni-spc-qdenga-clean-DEN-308-05-09-24.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 September 2024
File name
ie-ni-pl-qdenga-vial-pfs-clean-DEN-308-05-09-24.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 24 May 2024
File name
ie-ni-spc-qdenga-clean-psur2.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 February 2023
File name
ie-ni-pl-qdenga-vial-pfs-05-12-22.pdf
Reasons for updating
- New PIL for new product
Updated on 16 February 2023
File name
ie-ni-spc-qdenga-05-12-22 (002).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)