Last Updated on eMC 27-06-2018 View medicine  | Aspire 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 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:25-06-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2

Elderly  - has been updated

 

Section 4.4

 Special warnings and precautions for use

Sucidality - has been updated

 

Pathological gambling and other impulse control disorders - has been updated

 

Section 4.5 

 

Potential for other medicinal products to affect aripiprazole - Ketoconazole and other CYP3A4 inhibitors, Carbamazepine and other CYP3A4 inducers and Valproate and lithium have been updated

 

Section 4.6

 

Fertility, pregnancy and lactation - Newborn Infants, Breast-feeding and Fertility-have been updated

 

Section 4.7

 

Effects on ability to drive and use machines - has been updated

 

Section 4.8

 

Undesirable effects - Tabulated list of adverse reactions, Other findings and Pathological gambling and other impulse control disorders - have been updated

 

Section 5.1

 

Pharmacodynamic properties - Lipid parameters, Manic episodes in Bipolar I Disorder in children and adolescents - have been updated

Reasons for adding or updating:

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