Last Updated on eMC 15-08-2016 View medicine  | Internis Pharmaceuticals 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:04-08-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8:

• Addition of side effects for special population group (patients with renal impairment)

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:25-07-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 7 - MAH address has changed to Linthwaite, Huddersfield

Reasons for adding or updating:

  • Improved presentation of SPC

Date of revision of text on the SPC:14-08-2014

Legal Category:P

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:28-07-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0MARKETING AUTHORISATION HOLDER$0$0$0$0$0Internis Pharmaceuticals Limited$0$0Carradine House$0$0237 Regents Park Road$0$0London$0$0N3 3LF$0$0UK$0$0$0$0

Reasons for adding or updating:

  • New SPC for new product

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

Legal Category:P

Black Triangle (CHM): NO