PMDA drug package insert

フルダラ静注用50mg

PMDA Prescription drug · サノフィ株式会社 · package insert Aug 24, 2026

Key facts

Brand names フルダラ静注用50mg
Nonproprietary names フルダラビンリン酸エステル
Companies 製造販売元/サノフィ株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 874229
YJ codes 4229400D1033
Approval numbers 21700AMY00037
Package insert edition 第4版
Package insert date Aug 24, 2026
PMDA document key 780069_4229400D1033_5
PMDA company code 780069

At a glance

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