PMDA drug package insert

トロペロン錠0.5mg

PMDA Prescription drug · アルフレッサ ファーマ株式会社 · package insert Dec 1, 2025

Key facts

Brand names トロペロン錠0.5mg, トロペロン錠1mg, トロペロン錠3mg, トロペロン細粒1%
Nonproprietary names チミペロン
Companies 製造販売元/アルフレッサ ファーマ株式会社, 販売元/田辺ファーマ株式会社
Product type Prescription drug
Therapeutic category 抗精神病剤
Therapeutic category codes 871179
YJ codes 1179026F1020, 1179026F2027, 1179026F3023, 1179026C1040
Approval numbers 15800AMZ00614, 15800AMZ00615, 15800AMZ00616, 21400AMZ00142
Package insert edition 第4版
Package insert date Dec 1, 2025
PMDA document key 530258_1179026C1040_6
PMDA company code 530258

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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