Last Updated on eMC 29-11-2016 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 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:15-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Voriconazole Actavis 50mg,  200mg Film-coated Tablets – PL 30306/0623-4 - DK/H/2405/001-002/IB/001

 

Variation approval date15/09/2016

Variation approval received date –26/10/2016

 

Single Variation

Variation Type:  IB, C.I.2.a

 

Variation Description: The product information for the above listed DCP has been updated in line with: EPAR for Vfend (Pfizer Limited), last updated January 29, 2016 (EMEA/H/C/000387).

 

SmPC sections updated 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 10

PIL  sections updated – 2, 3, 4 and 6

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