Last Updated on eMC 19-01-2017 View medicine  | Teva Pharma B.V. 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:12-01-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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Type IB - A.1- Change in the name and/or address of the marketing authorization holder ). To register the  change in address of the Marketing Authorisation Holder `Teva Pharma BV' from current address at Computerweg 10, 3542 DR Utrecht, The Netherlands to Swensweg 5, 2031 GA Haarlem, The Netherlands. Consequentially, Section 7 of SPC, PIL and Label have been updated.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

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

Legal Category:POM

Black Triangle (CHM): NO