Cibinqo 50mg, 100mg and 200mg film-coated tablets
*Company:
Pfizer Healthcare IrelandStatus:
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 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