VEYVONDI 650 IU and 1300 IU powder and solvent for solution for injection
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 25 July 2024
File name
Ireland - Veyvondi - CSR PASS - approved11July2024 -clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
Admin updates + undesirable effects table updated (removed number and frequency by subject column).
Updated on 25 July 2024
File name
Ireland - Veyvondi - CSR PASS - approved11July2024 -clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
Admin updates + undesirable effects table updated (removed number and frequency by subject column).
Updated on 04 December 2023
File name
ie-spc-veyvondi-newindication-adultprophy-clean-approved15nov23.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Update to include adult prophylaxis indication
Updated on 04 December 2023
File name
ie-pl-veyvondi-newindication-adultprophy-clean-approved15nov23.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Update to include adult prophylaxis
Updated on 05 September 2023
File name
ie-spc-veyvondi-bromobutyl-stopper-approved-clean-31Aug23.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of an alternative stopper
Updated on 05 September 2023
File name
ie-pl-veyvondi-bromobutyl-stopper-approved-clean-31Aug23.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Addition of alternative stopper
Updated on 05 September 2023
File name
ie-spc-veyvondi-bromobutyl-stopper-approved-clean-31Aug23.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of alternative stopper
Updated on 30 June 2023
File name
ie-spc-veyvondi-renewal-clean-approved26Jun23 (002).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2023
File name
ie-spc-veyvondi-ccds8-headache-proposed-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2023
File name
ie-pl-veyvondi-renewal-clean-approved26Jun23.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - marketing authorisation holder
- Removal of Black Inverted Triangle
Updated on 19 January 2023
File name
ie-pl-veyvondi-ccds8-headache-proposed-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 January 2023
File name
ie-spc-veyvondi-ccds8-headache-proposed-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 7 - Marketing authorisation holder
- 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 18 July 2022
File name
ie-spc-veyvondi-tib-section6.3update-commitment-clean.pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- 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 31 March 2022
File name
ie-spc-veyvondi-TIAG-LEOnamechange-clean-submitted22mar22.pdf
Reasons for updating
- 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 31 March 2022
File name
ie-pl-veyvondi-TIAG-LEOnamechange-clean-submitted22mar22.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 November 2020
File name
ie-pl-veyvondi-TIAIN-015-Aug-2020-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change in manufacturer name (batch release site) from Baxter AG to Takeda Manufacturing Austria AG .
Updated on 04 May 2020
File name
ie-pl-veyvondi-TII-010-Feb-2020-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 May 2020
File name
ie-spc-veyvondi-TII-010-Feb-2020-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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)
Updated on 04 May 2020
File name
ie-pl-veyvondi-TII-010-Feb-2020-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 09 April 2019
File name
ie-pl-31Aug18.pdf
Reasons for updating
- New PIL for new product
Updated on 09 April 2019
File name
ie-spc-31Aug18.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