Last Updated on eMC 31-01-2018 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 6 - date of revision

Reasons for adding or updating:

  • Improved presentation of PIL

Reasons for adding or updating:

  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 4 - possible side effects

Reasons for adding or updating:

  • Change to section 4 - possible side effects

Reasons for adding or updating:

  • Change to section 4 - possible side effects

Reasons for adding or updating:

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 1 - what the product is
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 5 - how to store
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Reasons for adding or updating:

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Reasons for adding or updating:

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Reasons for adding or updating:

  • Improved presentation of PIL

Reasons for adding or updating:

  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to how the medicine works
  • Change to date of revision

Reasons for adding or updating:

  • Improved Electronic Presentation
  • Updates to formatting

Reasons for adding or updating:

  • Change to information about pregnancy or lactation

Reasons for adding or updating:

  • Change to MA holder contact details

Reasons for adding or updating:

  • Change to, or new, use for medicine

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to side-effects

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to side-effects

Reasons for adding or updating:

  • Improved Electronic Presentation
  • Change to date of revision

Reasons for adding or updating:

  • Changes to therapeutic indications
  • Change to date of revision
  • Change to, or new, use for medicine
  • Change to side-effects

Reasons for adding or updating:

  • New PIL for new product