PMDA drug package insert

ゾレドロン酸点滴静注4mg/5mL「NK」

PMDA Prescription drug · 高田製薬株式会社 · package insert Sep 29, 2023

Key facts

Brand names ゾレドロン酸点滴静注4mg/5mL「NK」
Nonproprietary names ゾレドロン酸水和物
Companies 製造販売元/高田製薬株式会社, 発売元/日本化薬株式会社
Product type Prescription drug
Therapeutic category 骨吸収抑制剤
Therapeutic category codes 873999
YJ codes 3999423A1060
Approval numbers 22600AMX00349
Package insert edition 第1版
Package insert date Sep 29, 2023
PMDA document key 400186_3999423A1060_1
PMDA company code 400186

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:

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