Cibinqo 50mg, 100mg and 200mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Pfizer Healthcare Ireland Unlimited Company
  • Status:

    Updated
  • 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 30 October 2024

File name

Adv SPC CQ 10_0 IE clean.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 20 August 2024

File name

Adv SPC CQ 9_0 IE clean.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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 has been updated as follows: Section 6.3 increase in shelf life from 3 years to 4 years

Updated on 27 March 2024

File name

Adv SPC CQ 80 IE clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 March 2024

File name

Adv PIL CQ 70 IE NI clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision

Updated on 29 February 2024

File name

AdvPILCQ60IENIclean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 February 2024

File name

Adv SPC CQ 7_0 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 27 February 2024

File name

AdvSPCCQ80IEclean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC IE and SPC NI has been updated as follows: Section 4.1 and 4.2 updated with addition of indication for adolescents. Section 4.8 updated in line with data cut from Sept 2022. Section 5.3 updated regarding the potential risk of bone effects in pediatrics  

Updated on 27 February 2024

File name

AdvPILCQ50IENIclean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 June 2023

File name

Adv SPC CQ 7_0 IE clean.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 16 March 2023

File name

AdvSPCCQ60IEclean.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IB update the long-term efficacy data in section 5.1 of the SmPC to include efficacy data through Week 96.

Updated on 14 March 2023

File name

AdvSPCCQ50IEclean.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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Safety updates to section 4.2 (Posology and method of administration), section 4.4 (Special warnings and precautions for use), Annex II D, and Section 2 of the package leaflet per PRAC request of all JAKi authorised for treatment of inflammatory disorders

Updated on 14 March 2023

File name

AdvPILCQ40IENIclean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 14 October 2022

File name

Adv SPC CQ 4_0 IE clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 October 2022

File name

Adv PIL CQ 3_0 IE NI clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 17 August 2022

File name

AdvPILCQ20IENIclean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 17 August 2022

File name

AdvSPCCQ20IEclean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 17 August 2022

File name

AdvPILCQ20IENIclean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 21 June 2022

File name

Adv SPC CQ 1_0 IE NI.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 June 2022

File name

Adv PIL CQ 1_0 IE NI.pdf

Reasons for updating

  • New PIL for new product