Aripiprazole Zentiva 5 mg 10 mg 15 mg & 30 mg tablets *
Pharmacy Only: Prescription

  • Company:

    Zentiva Pharma UK Limited
  • Status:

    No Recent Update
  • Legal 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 23 August 2021

File name

m1-3-1-spc-combined-clean-CAP-tabs_1629732032.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_1629731917.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_1629731876.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.