PMDA drug package insert

テビケイ錠50mg

PMDA Prescription drug · ヴィーブヘルスケア株式会社 · package insert Aug 25, 2026

Key facts

Brand names テビケイ錠50mg
Nonproprietary names ドルテグラビルナトリウム
Companies 製造販売元/ヴィーブヘルスケア株式会社, 販売元/グラクソ・スミスクライン株式会社
Product type Prescription drug
Therapeutic category HIVインテグラーゼ阻害剤
Therapeutic category codes 87625
YJ codes 6250038F1023
Approval numbers 22600AMX00561
Package insert edition 第9版
Package insert date Aug 25, 2026
PMDA document key 166272_6250038F1023_1
PMDA company code 166272

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)