PMDA drug package insert

スルピリド錠100mg「アメル」

PMDA Prescription drug · 共和薬品工業株式会社 · package insert May 20, 2025

Key facts

Brand names スルピリド錠100mg「アメル」, スルピリド錠200mg「アメル」
Nonproprietary names スルピリド
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category 精神情動安定剤
Therapeutic category codes 871179
YJ codes 1179016F1159, 1179016F2120
Approval numbers 21700AMZ00357, 21700AMZ00360
Package insert edition 第3版
Package insert date May 20, 2025
PMDA document key 672173_1179016F1159_2
PMDA company code 672173

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:

Browse all PMDA approved drugs and package inserts (Japan)