Aripiprazole Zentiva 5 mg 10 mg 15 mg & 30 mg tablets
*Company:
Zentiva Pharma UK LimitedStatus:
No Recent UpdateLegal 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 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.