PMDA drug package insert

スインプロイク錠0.2mg

PMDA Prescription drug · 塩野義製薬株式会社 · package insert Sep 17, 2026

Key facts

Brand names スインプロイク錠0.2mg
Nonproprietary names ナルデメジントシル酸塩
Companies 製造販売元/塩野義製薬株式会社
Product type Prescription drug
Therapeutic category 経口末梢性μオピオイド受容体拮抗薬
Therapeutic category codes 872359
YJ codes 2359007F1020
Approval numbers 22900AMX00513000
Package insert edition 第3版
Package insert date Sep 17, 2026
PMDA document key 340018_2359007F1020_1
PMDA company code 340018

At a glance

  • 1–9 Package insert revisions
  • 1–9 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:

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