22 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral and non-depot antipsychotics with less…
Medicine Compliance Aid Stability
LatudaSunovion Pharmaceuticals Europe Ltd
Sunovion Pharmaceuticals Europe Ltd
Tablets f/c 18.5mg, 37mg, 74mg.
A3 · Amber 3 No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from light.
1 October 2015
Lactation Safety Information
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties
Long half-life increases risk of accumulation in breastfed infants
9 November 2018
LatudaSchizophrenia in children and adolescents aged 13 years and older
Licence extension / variation
Development and Regulatory status
Phase III Clinical Trials
Jul 20Licence extension to include use in adolescents aged 13 and over approved in the EU .
Jul 20Recommended for EU approval by CHMP - the amended indication is "for the treatment of schizophrenia in adults and adolescents aged 13 years and over." 
Dopamine D2 receptor & serotonin 5HT2A/7 receptor antagonist
Childhood schizophrenia affects about 1.6 to 1.9 per 100,000 child population, prevalence increasing from the age of 14 years onwards .
Schizophrenia in children and adolescents aged 13 years and older