Vokanamet 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 17 June 2025
File name
Vokanamet-SmpC-Clean June 2025.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Warnings and precautions updated
Updated on 17 June 2025
File name
Vokanamet-PIL-Clean June 2025.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
Warnings and precautions updated
Updated on 16 October 2024
File name
Vokanamet-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 4.6 - Pregnancy and lactation
- 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
Vokanamet-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
Warnings updated for upcoming surgery / procedures
Updated on 11 January 2024
File name
IE-Vokanamet SmPC- Dec 2023-II- Section 4.6-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.6 updated
Updated on 28 June 2023
File name
IE-Vokanamet-Approved-June 2023-SmPC-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Vitamin B12 decrease/deficiency added
Section 4.4 - Diabetic ketoacidosis added
Section 4.5 - Lithium added
Section 4.8 - Vitamin B12 decrease/deficiency added and footnotes to table updated
Updated on 28 June 2023
File name
NI & IE-Vokanamet-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
Vokanamet 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
Vokanamet 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
Vokanamet-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