Last Updated on eMC 28-11-2017 View medicine  | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 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 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:17-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2: QRD Update

Section 4.3: QRD Update

Section 4.8: Addition of Reproductive system and breast disorders - Frequency Unknown: Sexual dysfunction including erectile dysfunction and decreased libido

Section 10 - Revision date

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