Xaluprine 20 mg/ml oral suspension
*Company:
Nova Laboratories Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 January 2025
File name
ie-spc-2025-01-10.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 10 January 2025
File name
ie-pl-2025-01.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 24 June 2024
File name
ie-pl-2024-07.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PRAC considers a causal relationship between mercaptopurine and stomatitis, cheilitis, mucosal inflammation, pellagra, cholestasis of pregnancy and coagulation factors decreased is at least a reasonable possibility. The product information is amended accordingly.
Updated on 24 June 2024
File name
ie-spc-2024-06-20.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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
The PRAC considers a causal relationship between mercaptopurine and stomatitis, cheilitis, mucosal inflammation, pellagra, cholestasis of pregnancy and coagulation factors decreased is at least a reasonable possibility. The product information is amended accordingly.
Updated on 18 May 2023
File name
SPC (17-05-2023).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 18 May 2023
File name
PIL (17-05-2023).pdf
Reasons for updating
- New PIL for new product
Updated on 27 June 2022
File name
SPC (21-06-2022).pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to restricted prescription (C)
Updated on 27 June 2022
File name
SPC (21-06-2022).pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 24 June 2022
File name
SPC (21-06-2022).pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to restricted prescription (C)
Updated on 23 June 2022
File name
SPC (21-06-2022).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Updated on 13 January 2022
File name
SPC.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to restricted prescription (C)
Updated on 07 February 2021
File name
PIL.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Addition of Pronav Clinical Ltd. as manufacturer.
Updated on 08 June 2020
File name
Summary of Product Characteristics.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 restricted prescription (C)
Updated on 08 June 2020
File name
Package Leaflet.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
Updated on 17 December 2019
File name
Summary of product characteristics.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 17 December 2019
File name
Package leaflet.pdf
Reasons for updating
- New PIL for new product
Nova Laboratories Ireland Limited
Address:
Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, IrelandTelephone:
+44 (0) 116 223 0100Medical Information Direct Line:
+44 (08) 707 120 655Customer Care direct line:
+44 (0) 116 223 0099