Last Updated on eMC 29-03-2017 View medicine  | Basilea Pharmaceutica International 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 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:20-02-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

$0p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 13.0px 'Century Gothic'; -webkit-text-stroke: #000000}span.s1 {font-kerning: none}$0$0In section 5.3, the following sentence has been added: Environmental risk assessment has shown that Cresemba may pose a risk for the aquatic environment.$0$0 $0$0In section 6.6, the following sentence has been added: This medicinal product may pose a risk to the environment (see section 5.3).$0

Reasons for adding or updating:

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC:01-03-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

$0The date of first authorisation has been corrected:$0$0$0$0$09.      DATE OF FIRSTAUTHORISATION/RENEWAL OF THE AUTHORISATION$015 October 2015

Reasons for adding or updating:

  • New SPC for new product

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

Legal Category:POM

Black Triangle (CHM): YES