PMDA drug package insert

ブロナンセリン錠2mg「DSPB」

PMDA Prescription drug · 住友ファーマプロモ株式会社 · package insert Aug 20, 2026

Key facts

Brand names ブロナンセリン錠2mg「DSPB」, ブロナンセリン錠4mg「DSPB」, ブロナンセリン錠8mg「DSPB」, ブロナンセリン散2%「DSPB」
Nonproprietary names ブロナンセリン
Companies 製造販売元/住友ファーマプロモ株式会社, 販売元/住友ファーマ株式会社
Product type Prescription drug
Therapeutic category 抗精神病剤
Therapeutic category codes 871179
YJ codes 1179048F1043, 1179048F2040, 1179048F3046, 1179048B1033
Approval numbers 23100AMX00158, 23100AMX00159, 23100AMX00160, 23100AMX00161
Package insert edition 第13版
Package insert date Aug 20, 2026
PMDA document key 370242_1179048B1033_1
PMDA company code 370242

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)