PMDA drug package insert

ニトロール点滴静注50mgバッグ

PMDA Prescription drug · エーザイ株式会社 · package insert Jul 31, 2023

Key facts

Brand names ニトロール点滴静注50mgバッグ, ニトロール点滴静注100mgバッグ
Nonproprietary names 硝酸イソソルビド
Companies 製造販売元/エーザイ株式会社
Product type Prescription drug
Therapeutic category codes 872171
YJ codes 2171404A8039, 2171404A9035
Approval numbers 22000AMX00039000, 22000AMX00040000
Package insert edition 第1版
Package insert date Jul 31, 2023
PMDA document key 170033_2171404A8039_1
PMDA company code 170033

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)