PMDA drug package insert

ゼローダ錠300

PMDA Prescription drug · チェプラファーム株式会社 · package insert Feb 19, 2026

Key facts

Brand names ゼローダ錠300
Nonproprietary names カペシタビン
Companies 製造販売元/チェプラファーム株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 874223
YJ codes 4223005F1022
Approval numbers 21500AMZ00400
Package insert edition 第4版
Package insert date Feb 19, 2026
PMDA document key 450900_4223005F1022_2
PMDA company code 450900

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None 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)