PMDA drug package insert

オランザピンOD錠2.5mg「日医工」

PMDA Prescription drug · 日医工株式会社 · package insert Aug 25, 2026

Key facts

Brand names オランザピンOD錠2.5mg「日医工」, オランザピンOD錠5mg「日医工」, オランザピンOD錠10mg「日医工」
Nonproprietary names オランザピン
Companies 製造販売元/日医工株式会社
Product type Prescription drug
Therapeutic category 抗精神病薬・双極性障害治療薬・制吐剤
Therapeutic category codes 871179, 872391
YJ codes 1179044F6136, 1179044F4117, 1179044F5113
Approval numbers 22900AMX00731000, 22800AMX00265000, 22800AMX00266000
Package insert edition 第4版
Package insert date Aug 25, 2026
PMDA document key 530169_1179044F4117_1
PMDA company code 530169

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

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