Last Updated on eMC 20-03-2017 View medicine  | Thornton & Ross 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 6.5 - Nature and contents of container

Date of revision of text on the SPC:15-03-2017

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Deletion of the 100g white polyethylene/aluminium/co-polymer LDPE laminated plastic tube, with polypropylene cap.

Reasons for adding or updating:

  • 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:18-11-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3:

• Addition of QRD hypersensitivity warnings

 

Section 4.8:

• Addition of occasional hypersensitivity/irritant reactions

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:04-11-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 - Addition of new tube with MDPE liner

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC:24-09-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2 removal of BP from ingredients

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:GSL

Black Triangle (CHM): NO