PMDA drug package insert

エビリファイ錠1mg

PMDA Prescription drug · 大塚製薬株式会社 · package insert Dec 15, 2025

Key facts

Brand names エビリファイ錠1mg, エビリファイ錠3mg, エビリファイ錠6mg, エビリファイ錠12mg, エビリファイ散1%
Nonproprietary names アリピプラゾール
Companies 製造販売元/大塚製薬株式会社
Product type Prescription drug
Therapeutic category 抗精神病薬
Therapeutic category codes 871179
YJ codes 1179045F8028, 1179045F1023, 1179045F2020, 1179045F3026, 1179045B1021
Approval numbers 22800AMX00691, 21800AMZ10013, 21800AMZ10014, 21900AMX00907, 21800AMZ10012
Package insert edition 第6版
Package insert date Dec 15, 2025
PMDA document key 180078_1179045B1021_1
PMDA company code 180078

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:

Browse all PMDA approved drugs and package inserts (Japan)