PMDA drug package insert

タモキシフェン錠10mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Mar 17, 2026

Key facts

Brand names タモキシフェン錠10mg「サワイ」, タモキシフェン錠20mg「サワイ」
Nonproprietary names タモキシフェンクエン酸塩
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 抗乳癌剤
Therapeutic category codes 874291
YJ codes 4291003F1228, 4291003F2062
Approval numbers 22300AMX00478000, 22300AMX00106000
Package insert edition 第2版
Package insert date Mar 17, 2026
PMDA document key 300119_4291003F1228_1
PMDA company code 300119

At a glance

  • 1–9 Package insert revisions
  • 10–99 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)