PMDA drug package insert

ベラプロストNa錠20μg「NIG」

PMDA Prescription drug · 日医工岐阜工場株式会社 · package insert Feb 1, 2026

Key facts

Brand names ベラプロストNa錠20μg「NIG」, ベラプロストNa錠40μg「NIG」
Nonproprietary names ベラプロストナトリウム
Companies 製造販売元/日医工岐阜工場株式会社, 販売元/日医工株式会社
Product type Prescription drug
Therapeutic category 経口プロスタサイクリン(PGI2)誘導体製剤
Therapeutic category codes 873399
YJ codes 3399005F1323, 3399005F2109
Approval numbers 22500AMX01254, 22500AMX01255
Package insert edition 第2版
Package insert date Feb 1, 2026
PMDA document key 581120_3399005F1323_1
PMDA company code 581120

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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