Last Updated on eMC 13-07-2016 View medicine  | Otsuka Pharmaceuticals (UK) Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:29-04-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes to section 4.8 and 10

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:28-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.4       Special warnings and precautions for use

-  Addition of "Abilify Maintena should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted."

5.1       Pharmacodynamic properties


- Addition of section on Prolactin, Acute treatment of schizophrenia in adults.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO