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Articles
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…
Medicine Compliance Aid Stability
LatudaSunovion Pharmaceuticals Europe Ltd
Sunovion Pharmaceuticals Europe Ltd
Latuda
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
Caution
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
Information
Latuda
Licence extension / variation
Sunovion
Dainippon Sumitomo
Development and Regulatory status
Launched
Launched
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]
Category
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
Oral