PMDA drug package insert

ロドピン錠25mg

PMDA Prescription drug · LTLファーマ株式会社 · package insert Apr 15, 2025

Key facts

Brand names ロドピン錠25mg, ロドピン錠50mg, ロドピン錠100mg, ロドピン細粒10%, ロドピン細粒50%
Nonproprietary names ゾテピン
Companies 製造販売/LTLファーマ株式会社
Product type Prescription drug
Therapeutic category 統合失調症治療剤
Therapeutic category codes 871179
YJ codes 1179024F1030, 1179024F2036, 1179024F3024, 1179024C1033, 1179024C2021
Approval numbers 15600AMZ01021, 15600AMZ01022, 15600AMZ01023, 15600AMZ01024, 15600AMZ01025
Package insert edition 第5版
Package insert date Apr 15, 2025
PMDA document key 171911_1179024C1033_4
PMDA company code 171911

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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