Last Updated on eMC 12-07-2018 View medicine  | Merck Sharp & Dohme Limited 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

Date of revision of text on the SPC:15-06-2018

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



  • Section 7 Marketing Authorisation Holder: The MAH has been changed from Merck Sharp & Dohme Ltd, UK to Merck Sharp & Dohme B.V, The Netherlands.

 

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:21-03-2018

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 6.3 Shelf life: Extension of the shelf-life in accordance with the approved stability protocol, from 2 years to 3 years.

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:04-09-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



The changes made to the SmPC are as follows:

·         Section 4.8 Undesirable effects: The reporting of suspected adverse reactions statement for the UK has been updated in line with Appendix V – Adverse drug reporting details dated 11th July 2017.

·         Section 6.3 Shelf life: Extension of the shelf-life in accordance with the approved stability protocol, from 18 months to 24 months, when stored at 2 °C to 8 °C.

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