PMDA drug package insert

アムヴトラ皮下注25mgシリンジ

PMDA Prescription drug · Alnylam Japan株式会社 · package insert Jun 24, 2025

Key facts

Brand names アムヴトラ皮下注25mgシリンジ
Nonproprietary names ブトリシランナトリウム
Companies 製造販売元/Alnylam Japan株式会社
Product type Prescription drug
Therapeutic category トランスサイレチン型アミロイドーシス治療薬
Therapeutic category codes 87129, 87219
YJ codes 1290401G1021
Approval numbers 30400AMX00432000
Package insert edition 第2版
Package insert date Jun 24, 2025
PMDA document key 112773_1290401G1021_1
PMDA company code 112773

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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)