PMDA drug package insert

クエチアピン錠25mg「VTRS」

PMDA Prescription drug · ヴィアトリス・ヘルスケア合同会社 · package insert Oct 8, 2026

Key facts

Brand names クエチアピン錠25mg「VTRS」, クエチアピン錠100mg「VTRS」, クエチアピン錠200mg「VTRS」
Nonproprietary names クエチアピンフマル酸塩
Companies 製造販売元/ヴィアトリス・ヘルスケア合同会社, 販売元/ヴィアトリス製薬合同会社
Product type Prescription drug
Therapeutic category 抗精神病剤
Therapeutic category codes 871179
YJ codes 1179042F1216, 1179042F2220, 1179042F3227
Approval numbers 22400AMX01133, 22400AMX01134, 22400AMX01135
Package insert edition 第4版
Package insert date Oct 8, 2026
PMDA document key 730869_1179042F1216_1
PMDA company code 730869

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)