Aripiprazole Zentiva 5 mg 10 mg 15 mg & 30 mg tablets
*Company:
Zentiva Pharma UK LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 June 2026
File name
For Med IE PIL COMON ARIPIPRAZOLE ZTV TAB IE (3) - new 3.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
EPAR update - Update concerns change of the term ‘pathological gambling’ to the current MedDRA term ‘gambling disorder’ throughout the PI. Further, originator amended the wording on ketoconazole in section 2 PIL to reflect that oral ketoconazole is no longer authorised in the EU for the treatment of fungal infections.
Updated on 12 June 2026
File name
SPC- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EPAR update - Update concerns change of the term ‘pathological gambling’ to the current MedDRA term ‘gambling disorder’ throughout the PI. Further, originator amended the wording on ketoconazole in section 2 PIL to reflect that oral ketoconazole is no longer authorised in the EU for the treatment of fungal infections.
Updated on 01 October 2025
File name
FOR MED IE PIL COMON ARIPIPRAZOLE ZTV TAB IE - new.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 30 July 2025
File name
PIL - clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 30 July 2025
File name
SPC- 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)
Free text change information supplied by the pharmaceutical company
United Kingdom removed from the SPC
Updated on 29 May 2024
File name
m1-3-1-spc-combined-clean change-CAP-tabs.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Blood prolactin decreased added to table under Endocrine disorders
Updated on 16 September 2022
File name
m1-3-2-leaflet-mock-up-CAP-tabs.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 23 August 2021
File name
m1-3-1-spc-combined-clean-CAP-tabs.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
IB/C.I.2a):
Update of Product Information in line with the current Product Information of the reference product Abilify (procedure number EMEA/H/C/000471). Effecting section 4.8 (SmPC) and in section 4 (PIL) following safety changes adopted in EPAR for the originator Abilify (EMEA/H/C/000471). All changes have been made in line with the originator.
Updated on 23 August 2021
File name
m1-3-1-spc-combined-clean-CAP-tabs.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 August 2021
File name
Pages from 813338_PIL_GB.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
IB/C.I.2a):
Update of Product Information in line with the current Product Information of the reference product Abilify (procedure number EMEA/H/C/000471). Effecting section 4.8 (SmPC) and in section 4 (PIL) following safety changes adopted in EPAR for the originator Abilify (EMEA/H/C/000471). All changes have been made in line with the originator.
Zentiva Pharma UK Limited
Address:
First Floor, Andrews House, College Road, Guildford, GU1 4QB, UKMedInfo@zentiva.comTelephone:
+353 818 882 243Medical Information Direct Line:
+353 818 882 243 ,