PMDA drug package insert

ロゼバラミン筋注用25mg

PMDA Prescription drug · エーザイ株式会社 · package insert Dec 1, 2025

Key facts

Brand names ロゼバラミン筋注用25mg
Nonproprietary names メコバラミン
Companies 製造販売元/エーザイ株式会社
Product type Prescription drug
Therapeutic category 筋萎縮性側索硬化症用剤
Therapeutic category codes 87119
YJ codes 1190410E1024
Approval numbers 30600AMX00262000
Package insert edition 第3版
Package insert date Dec 1, 2025
PMDA document key 170033_1190410E1024_1
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
  • 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)