Last Updated on eMC 16-11-2017 View medicine  | Ferring Pharmaceuticals 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 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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
  • Change to section 4.9 - Overdose
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:23-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

QRD & Core Safety Profile update

Reasons for adding or updating:

  • Previous version of SPC reinstated

Date of revision of text on the SPC:26-05-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

pervious version reinstated

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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
  • Change to section 4.9 - Overdose
  • Retired pending re-submission

Date of revision of text on the SPC:27-07-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SPC updated according to recommendation for Core Safety Profile for Mesalazine.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:26-05-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2 (method of administration) - 4g once daily dose added.

Reasons for adding or updating:

  • Change to MA holder contact details

Date of revision of text on the SPC:27-06-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

New MAH address: Drayton Hall, Church Road, West Drayton, UB7 7PS

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:29-09-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

sec. 4.2 - The recommanded dosage for Maintenance treatment has changed to "2g mesalazine once daily".  

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

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

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied