PMDA drug package insert

シンフェーズT28錠

PMDA Prescription drug · 科研製薬株式会社 · package insert Dec 1, 2025

Key facts

Brand names シンフェーズT28錠
Nonproprietary names ノルエチステロン・エチニルエストラジオール
Companies 製造販売元/科研製薬株式会社
Product type Prescription drug
Therapeutic category 経口避妊剤
Therapeutic category codes 872549
YJ codes 254910AF1042
Approval numbers 21900AMX01800
Package insert edition 第4版
Package insert date Dec 1, 2025
PMDA document key 200022_254910AF1042_3
PMDA company code 200022

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes 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)