PMDA drug package insert

ビルダグリプチン錠50mg「フェルゼン」

PMDA Prescription drug · ダイト株式会社 · package insert Oct 30, 2025

Key facts

Brand names ビルダグリプチン錠50mg「フェルゼン」
Nonproprietary names ビルダグリプチン
Companies 製造販売元/ダイト株式会社, 販売元/株式会社フェルゼンファーマ
Product type Prescription drug
Therapeutic category 選択的DPP-4阻害薬; [2型糖尿病治療薬]
Therapeutic category codes 873969
YJ codes 3969011F1110
Approval numbers 30600AMX00200000
Package insert edition 第4版
Package insert date Oct 30, 2025
PMDA document key 400073_3969011F1110_1
PMDA company code 400073

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)