Last Updated on eMC 03-01-2018 View medicine  | Merck - Pfizer 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 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-12-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



5.1 Pharmacodynamic properties- ATC code has changed from not yet assigned to L01XC31.

6.3 Shelf life - Under, After preparation of infusion, '(see section 6.6)' has been removed.

6.6 Special precautions for disposal and other handling - 'The diluted solution must not be stored longer than a total of 24 hours under refrigerated conditions, (2°C to 8°C) or up to 8 hours at room temperature (20°C to 25°C)' has been removed.

10. DATE OF REVISION OF THE TEXT - has changed to 12/2017

Reasons for adding or updating:

  • New SPC for new product