PMDA drug package insert

ギリアデル脳内留置用剤7.7mg

PMDA Prescription drug · エーザイ株式会社 · package insert Jun 16, 2026

Key facts

Brand names ギリアデル脳内留置用剤7.7mg
Nonproprietary names カルムスチン
Companies 製造販売(輸入)元/エーザイ株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 874219
YJ codes 4219700X1020
Approval numbers 22400AMX01402000
Package insert edition 第2版
Package insert date Jun 16, 2026
PMDA document key 170033_4219700X1020_2
PMDA company code 170033

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)