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 24 July 2025
File name
ie-spc-qdenga-clean-eye pain-25.07.17.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to section 4.8 to add eye pain to the list of adverse reactions.
Sections 4.3 and 4.5 - Editorial update for clarity that the '4 weeks prior to vaccination' period does apply for high doses of systemic corticosteroids, however such period does not apply for any other medicinal products with known immunosuppressive properties including chemotherapy.
Section 5.1 - Editorial update adding 'vaccine' to the sub-section header 'Co-administration with HPV vaccine' for clarity and consistency with text in SmPC Section 4.5.
Section 6.6 - Information for HCPs (instructions for use) – Editorial update to remove 15 min holding time at room temperature prior to reconstitution for clarity and practical use.
Updated on 24 July 2025
File name
ie-pl-qdenga-vial-pfs-clean-eye pain-25.07.17.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Section 4 - Updated to add 'eye pain' as a possible adverse reaction.
Section 2 - Editorial update for clarity that the '4 weeks prior to vaccination' period does apply for high doses of systemic corticosteroids, however such period does not apply for any other medicinal products with known immunosuppressive properties including chemotherapy.
Package leaflet section on information for HCPs (instructions for use) – Editorial update to remove 15 min holding time at room temperature prior to reconstitution for clarity and practical use.
Updated on 04 June 2025
File name
ie-spc-qdenga-clean-psur-4-2025.06.02-TDN-000555525.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of adverse events Thrombocytopenia and Petechiae to section 4.8
Updated on 04 June 2025
File name
ie-pl-qdenga-vial-pfs-clean-psur-4-2025.06.02-TDN-000555517.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of adverse events Thrombocytopenia and Petechiae
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)
Takeda Products Ireland Ltd
Address:
5 Riverwalk Citywest Business Campus Dublin 24Medical Information E-mail:
medinfoemea@takeda.comMedical Information Direct Line:
1800 937970 , +44 3333 000 181