PMDA drug package insert

オンスイク注ミリオペン総量1500単位

PMDA Prescription drug · 日本イーライリリー株式会社 · package insert Sep 16, 2026

Key facts

Brand names オンスイク注ミリオペン総量1500単位
Nonproprietary names インスリン エフシトラ アルファ(遺伝子組換え)
Companies 製造販売元/日本イーライリリー株式会社
Product type Prescription drug
Therapeutic category 週1回持効型溶解インスリンアナログ注射液
Therapeutic category codes 872492
YJ codes 24924A8G1027
Approval numbers 30800AMX00343
Package insert edition 第1版
Package insert date Sep 16, 2026
PMDA document key 530471_24924A8G1027_1
PMDA company code 530471

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • No 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)