Ruxience 100mg and 500mg Concentrate for Solution for Infusion *
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland
  • 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 26 August 2022

File name

6308daf6181b0.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

6308dab64509d.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_1632754547.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_1632754438.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  • Joint PIL superseded by individual PILs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_1630487238.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_1630487104.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_1619071069.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_1614010868.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_1608742648.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_1598959746.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_1599492387.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_1598959794.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_1598959746.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Product Launch 01-Sept-2020