Last Updated on eMC 07-08-2017 View medicine  | Actavis UK 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 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-03-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Voriconazole Actavis 200mg Powder for Solution for Infusion - PL 30306/0570 ( DK/H/2522/001/IB/001 )

 

 

Variation approval – 22.03.2017

(Variation approval  received date – 11.07.2017 )

 

Single Variation

Variation type: IB, B.II.f.1.b.1

 

Variation Description: Shelf Life extension from 18 months to 24 months

 

 

SmPC section(s) updated – 6.3 & 10

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): NO