PMDA drug package insert

クエチアピン錠25mg「日新」

PMDA Prescription drug · 日新製薬株式会社 · package insert Oct 29, 2024

Key facts

Brand names クエチアピン錠25mg「日新」, クエチアピン錠100mg「日新」, クエチアピン錠200mg「日新」
Nonproprietary names クエチアピンフマル酸塩
Companies 製造販売元/日新製薬株式会社, 販売元/共創未来ファーマ株式会社
Product type Prescription drug
Therapeutic category 抗精神病剤
Therapeutic category codes 871179
YJ codes 1179042F1178, 1179042F2174, 1179042F3170
Approval numbers 22400AMX01082, 22400AMX01081, 22400AMX01080
Package insert edition 第2版
Package insert date Oct 29, 2024
PMDA document key 530113_1179042F1178_2
PMDA company code 530113

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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)