Invokana 100 mg and 300mg film coated tablets
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 September 2025
File name
Invokana-SmPC-clean-IE Approved August 25.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Paediatric indication added
Updated on 02 September 2025
File name
Invokana-PIL-clean-IE Approved August 25.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 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Paediatric Indication added
Updated on 16 October 2024
File name
Invokana-SmPC-clean-IE Approved Sept 24.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 October 2024
File name
Invokana-PIL-clean-UKNI & IE Approved Sept 24.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Warning and precautions updated regarding upcoming surgeries / procedures
Updated on 28 June 2023
File name
IE-Invokana-Approved -June 2023-SmPC-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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Diabetic ketoacidosis added
Section 4.5 - Lithium added
Updated on 28 June 2023
File name
NI & IE-Invokana-Approved-June 2023-PIL-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Free text change information supplied by the pharmaceutical company
Section 2 - interactions with Lithium added
Updated on 15 June 2023
File name
Invokana SmpC Approved feb 23.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 June 2023
File name
Invokana SmpC Approved May 23 - Article 61-3 IE details.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 June 2023
File name
Invokana-PIL-clean Approved May 23.pdf
Reasons for updating
- New PIL for new product
A. Menarini Pharmaceuticals Ireland Ltd
Address:
Castlecourt, Monkstown Farm, Monsktown, Glenageary, Co. Dublin, IrelandMedical Information E-mail:
medinfo@menarini.ieTelephone:
+353 1 284 6744Fax:
+353 1 284 6769Medical Information Direct Line:
1800 283 045