Last Updated on eMC 07-12-2017 View medicine  | Dermal Laboratories Limited 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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.1(List of excipients), Citric Acid Anhydrous has been updated to Citric Acid.

In section 10 (Date of revision of the text), the date has changed to January 2017.  

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Date of revision of text on the SPC:01-02-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8 Undesirable effects, the following text has been added:

"Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard."

In section 10 Date of revision of the text, the date has changed to "February 2015"

Improved presentation of the SPC.

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-10-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.1 (List of excipients) : the following changes have been made: "Hydroxypropylmethylcellulose" has changed to "Hypromellose"; "Citric Acid" has changed to "Citric Acid Anhydrous"; "Polyoxyethylene Lauryl Ether" has changed to "Macrogol Lauryl Ether" and "Ethanol" has changed to "Ethanol Anhydrous".

In section 10 (Date of revision of the text) : the date has changed to "October 2008".

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-03-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 (Name of the Medicinal Product) : the name has changed to "Nicam 4% w/w Gel"

Section 10 (Date of revision of the text) : the date has changed to "March 2008"

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:01-09-2007

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 - Nature and contents of container - Deletion of text 'This is supplied as an original pack (OP)'
 
Section 10 - Date of revision of the text - Date changed to 'January 2005'

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:01-10-2004

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 - Nature and contents of container - Text has changed to "60g LDPE or co-extruded low density polyethylene laminate tube with white polypropylene cap.  This is supplied as an original pack (OP)."
 
Section 10 - Date of revision of the text - The date has changed to "October 2004."

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • New SPC for new product