Last Updated on eMC 14-07-2017 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 4.4 - 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 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:06-07-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



section 4.4 - addition of the following;

Visual  disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare condition diseases such as Central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

 

 

section 4.5 - Co-treatment with CYP3A inhibitor.

 

section 4.6 - Information on breast-feeding updated.

 

section 4.8 - reformatted and ADRs added/removed according to PRAC recommendations on signals

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO