PMDA drug package insert

ラベルフィーユ28錠

PMDA Prescription drug · 富士製薬工業株式会社 · package insert Sep 29, 2026

Key facts

Brand names ラベルフィーユ28錠
Nonproprietary names レボノルゲストレル・エチニルエストラジオール
Companies 製造販売元/富士製薬工業株式会社, 販売元/株式会社ネクイノ
Product type Prescription drug
Therapeutic category 経口避妊剤
Therapeutic category codes 872549
YJ codes 254910BF2051
Approval numbers 22400AMX00482
Package insert edition 第2版
Package insert date Sep 29, 2026
PMDA document key 670109_254910BF2051_1
PMDA company code 670109

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)