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Legality · Quetiapine

Is Quetiapine legal in Japan?

Confirmed against a primary sourceVerified July 14, 2026
Legal status
Quetiapine is a prescription medicine (shohosen-iyakuhin) and a poison-designation drug (gekiyaku), not a controlled drug: Seroquel (serokueru) is approved by the PMDA/MHLW under the Pharmaceutical and Medical Devices Act and is not listed under the Narcotics and Psychotropics Control Act.
Consequences if caught
Quetiapine carries no narcotics-control penalty; supply outside the prescription channel is a pharmaceuticals-law matter only.
If prescribed or medical
Prescribed as an atypical antipsychotic for schizophrenia, with an extended-release form (Bipresso) for bipolar depression; dispensed only on prescription.
Documentation
Quetiapine's approval and product information are documented on the PMDA register; dispensed as a prescription medicine and carried lawfully with a prescription.
Primary source