Last Updated on eMC 03-04-2017 View medicine  | Leo 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 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-03-2017

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Due to change of ownership, Section 7, Marketing Authorisation Holder has been amended to LEO Pharma A/S
Section 8, Marketing Authorisation Number has changed
Section 10, Date of revision of text has been amended

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Date of revision of text on the SPC:09-12-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Numerous changes have been made throughout the document to bring it in-line with the latest European SmPC template. Reference to the excipient cetostearyl alcohol is consequently now made in Section 2. Section 10 date of revision has been updated accordingly.

 

The respective Patient Information Leaflets and packaging have also been updated to ensure compliance with the European template.

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:19-06-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 has been updated to reflect a change in packaging of the 500g jar (to a white polypropylene jar with HDPE tamper evident lid).

Section 10 Date of Revision has also changed.

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:17-09-2012

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change to MA holder contact details

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:13-12-2010

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 7 the address of the MAH, Astellas Pharma Ltd., has been updated following a move to new premises.  This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.

 

In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7.  This date is updated to 13th December 2010.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use

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

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.4   Special warnings and special precautions for use

None known has been deleted and replaced with Cetostearyl alcohol may cause local skin reactions (e.g.contact dermatitis).

Reasons for adding or updating:

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

Reasons for adding or updating:

  • Addition of Legal Category
  • Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

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

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text
  • Change to section 2 - qualitative and quantitative composition

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied