Aripiprazole Zentiva 5 mg 10 mg 15 mg & 30 mg tablets *

  • 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

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.