Ruxience 100mg and 500mg Concentrate for Solution for Infusion
*Company:
Pfizer Healthcare IrelandStatus:
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 12 December 2023
File name
AdvPILbRI90IENI.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 29 August 2023
File name
AdvSPCbRI100IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Following the PRAC reviews of Ruxience’s PSUR, the PRAC committee recommended the following updates to the SPC.
• Update of sections 4.4 and 4.8 of the SPC to add a warning/precaution regarding enteroviral meningoencephalitis and to add the adverse reaction enteroviral meningoencephalitis with a frequency Not known.
• Update of section 4.4 of the SmPC to add a warning/precaution regarding the possibility of false negative serologic testing of infections.
Updated on 29 August 2023
File name
AdvPILbRI80IENI.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 December 2022
File name
AdvSPCbRI90IE.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 August 2022
File name
Adv SPC bRI 8_0 IE.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 August 2022
File name
AdvPILbRI70IENI.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 September 2021
File name
DEC202163033_Adv SPC bRI 7_0 IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
The SPC IE and SPC NI have been updated as follows:
1. Section 5.1: removal of space in ATC Code. Editorial update to Figure 2 to remove random vertical line and correct overlapping symbols in the legend.
2. Section 6.6: Use a sterile needle and syringe to prepare Ruxience added to provide clarification of handling instructions.
Updated on 27 September 2021
File name
DEC202163033_Adv PIL bRI 5_0 IE & NI clean.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 6 - date of revision
- Joint PIL superseded by individual PILs
- Change of distributor details
Updated on 01 September 2021
File name
DEC202158521_Adv SPC bRI 6_0 IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 September 2021
File name
DEC202158521_Adv PIL bRI 4_0 IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 22 April 2021
File name
DEC202126609_Adv PIL bRI 3_0 IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 February 2021
File name
Adv PIL bRI 2_1 IE.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change of distributor details
Updated on 23 December 2020
File name
Adv SPC bRI 5_0 IE.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 December 2020
File name
DEC202057509_Adv PIL bRI 2_0 IE.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change of distributor details
Updated on 07 September 2020
File name
Adv SPC bRI 4_0 UK & IE.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 01 September 2020
File name
DEC202057509_Adv SPC bRI 4_0 UK & IE.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Product Launch 01-Sept-2020
Updated on 01 September 2020
File name
DEC202057509_Adv PIL bRI 2_0 IE.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Product Launch 01-Sept-2020