PMDA drug package insert

ノリトレン錠10mg

PMDA Prescription drug · 住友ファーマ株式会社 · package insert Apr 1, 2022

Key facts

Brand names ノリトレン錠10mg, ノリトレン錠25mg
Nonproprietary names ノルトリプチリン塩酸塩
Companies 製造販売元/住友ファーマ株式会社, 提携/H. ルンドベック社(デンマーク)
Product type Prescription drug
Therapeutic category 情動調整剤
Therapeutic category codes 871179
YJ codes 1179004F1024, 1179004F2039
Approval numbers 14600AMY00122, 21400AMZ00161
Package insert edition 第1版
Package insert date Apr 1, 2022
PMDA document key 400093_1179004F1024_1
PMDA company code 400093

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:

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