PMDA drug package insert

ラツーダ錠20mg

PMDA Prescription drug · 住友ファーマ株式会社 · package insert Aug 3, 2026

Key facts

Brand names ラツーダ錠20mg, ラツーダ錠40mg, ラツーダ錠60mg, ラツーダ錠80mg
Nonproprietary names ルラシドン塩酸塩
Companies 製造販売元/住友ファーマ株式会社
Product type Prescription drug
Therapeutic category 抗精神病薬/双極性障害のうつ症状治療薬
Therapeutic category codes 871179
YJ codes 1179061F1022, 1179061F2029, 1179061F3025, 1179061F4021
Approval numbers 30200AMX00445, 30200AMX00446, 30200AMX00447, 30200AMX00448
Package insert edition 第11版
Package insert date Aug 3, 2026
PMDA document key 400093_1179061F1022_1
PMDA company code 400093

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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:

Browse all PMDA approved drugs and package inserts (Japan)