Last Updated on eMC 16-12-2014 View medicine  | Omega Pharma 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:29-10-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

Section 6.5 (Nature and contents of container) - Addition of alternative outer cap (tamper evident polypropylene) to the current approved cap

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:25-02-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

- In section 4.3 (contraindications): Addition of information with regards to Arachis oil (peanut oil) and the product being contraindicated for those with peanut allergy. Also added to be contraindicated to those with soya allergy as possible link between allergy to peanut and soya.$0$0$0$0- In section 4.4 (special warnings): Removal of information with regards to contraindicated for those with peanut and soya allergy (this information has moved to section 4.3). Information added that whilst children taking Abidec Multivitamin Drops, they should not take Vit A and D containing supplements unlessunder medical supervision. Addition of statement that the product should given to babies receiving >500mls of formula milk per day to avoid exceedingthe safe upper limit of Vitamin A; addition of statement that excessive dosage of vitamin A and D may lead tohypervitaminoses and due allowance should always be made for intake of thesevitamins from other sources; addition of warning for those with rare hereditary problems of fructoseintolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency not to take this medicine.$0$0$0$0$0$0- In section 10: Updated date of revision of the text to 25/02/2014$0

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:30-11-2012

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 7, the MAH holder address has changed from:

Chefaro UK Ltd

4th Floor,

Hamilton House

Mabledon Place

Bloomsbury

LONDON

WC1H 9BB

United Kingdom


To:

Omega Pharma Ltd.

1st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

                United Kingdom

In section 10, the revisions date has changed from 15th November 2010 to 30th November 2012

Reasons for adding or updating:

  • Change to section 10 date of revision of the text
  • Change to MA holder contact details

Date of revision of text on the SPC:15-11-2010

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updated MA holder address and Revision date.

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:16-06-2008

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 the old MA address has been updated.  Section 10 the revision date reflects acceptance of the notification of the MA change of address.

Reasons for adding or updating:

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