PMDA drug package insert

ガバペン錠200mg

PMDA Prescription drug · 富士製薬工業株式会社 · package insert Apr 30, 2026

Key facts

Brand names ガバペン錠200mg, ガバペン錠300mg, ガバペン錠400mg
Nonproprietary names ガバペンチン
Companies 製造販売元/富士製薬工業株式会社
Product type Prescription drug
Therapeutic category 抗てんかん剤
Therapeutic category codes 871139
YJ codes 1139007F1022, 1139007F2029, 1139007F3025
Approval numbers 21800AMZ10365, 21800AMZ10366, 21800AMZ10367
Package insert edition 第4版
Package insert date Apr 30, 2026
PMDA document key 670109_1139007F1022_3
PMDA company code 670109

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)