Last Updated on eMC 12-07-2018 View medicine  | Merck 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 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:10-07-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In Section 7 the new MAH is:

Merck Europe B.V.

Gustav Mahlerplein 102

1082 MA Amsterdam

The Netherlands

 

In section 10 date of revision has changed to:

07/2018

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 5.1 (Pharmacodynamic properties), has been changed to, Pharmacotherapeutic group: Selective Immunosuppressants, ATC code: L04AA40

Reasons for adding or updating:

  • New SPC for new product