Safety in Lactation: Antipsychotics

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…
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Medicine Compliance Aid Stability

LatudaSunovion Pharmaceuticals Europe Ltd

Sunovion Pharmaceuticals Europe Ltd
Tablets f/c 18.5mg, 37mg, 74mg.
A3 · Amber 3No 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

New Medicines

LatudaSchizophrenia in children and adolescents aged 13 years and older


Licence extension / variation
Dainippon Sumitomo

Development and Regulatory status

Phase III Clinical Trials
July 2020
Jul 20Licence extension to include use in adolescents aged 13 and over approved in the EU [5].
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." [4]


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 [1].
Schizophrenia in children and adolescents aged 13 years and older

Evidence based evaluations