PMDA drug package insert

オランザピン錠2.5mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Aug 25, 2026

Key facts

Brand names オランザピン錠2.5mg「サワイ」, オランザピン錠5mg「サワイ」, オランザピン錠10mg「サワイ」, オランザピン細粒1%「サワイ」
Nonproprietary names オランザピン
Companies 製造販売元/沢井製薬株式会社
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 1179044F1118, 1179044F2114, 1179044F3110, 1179044C1065
Approval numbers 22800AMX00119000, 22800AMX00120000, 22800AMX00121000, 22800AMX00122000
Package insert edition 第3版
Package insert date Aug 25, 2026
PMDA document key 300119_1179044C1065_1
PMDA company code 300119

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No 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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