Last Updated on eMC 07-12-2017 View medicine  | Diomed Developments 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:GSL

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:01-03-2015

Legal Category:GSL

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 "March 2015"

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-12-2008

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2 (Posology and method of administration) the following text has been added: "Treatment should continue for as long as necessary.  Depending on the severity of the condition, individual courses of treatment may take several weeks.  If there is no improvement within 12 weeks, or if the condition deteriorates at any stage, patients should seek advice from a doctor or pharmacist."

In section 4.4 (Special warnings and precautions for use) the following text has been added: "This product is not suitable for patients with severe acne, who should be encouraged to seek treatment advice from a doctor or pharmacist."

In section 5.2 (Pharmacokinetic properties) the following text has been added:  "Percutaneous absorption levels of nicotinamide, even following application to broken and inflamed acne skin, are very low compared to the oral doses routinely used in multivitamin products."

In section 6.1 (List of excipients) the following text has changed:  "Polyoxyethylene Lauryl Ether" replaced by "Macrogol Lauryl Ether".  "Ethanol" replaced by "Ethanol Anhydrous".

In section 6.5 (Nature and contents of container) the pack size has changed from "25g tube" to "10g tube".  Also text deleted "This is supplied as an original pack (OP)".

In section 9 (Renewal of Authorisation) the date has changed to "8 August 2008".

In section 10 (Date of Revision of the Text) the date has changed to "December 2008".

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC:01-10-2004

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 
Section 6.3 Shelf- life : details of 60g pack removed as not marketed.
 
Section 6.5 Nature and contents of container : details of 60g pack removed as not marketed.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC