PMDA drug package insert

ソホノスカプセル1mg

PMDA Prescription drug · IPSEN株式会社 · package insert Aug 28, 2026

Key facts

Brand names ソホノスカプセル1mg, ソホノスカプセル1.5mg, ソホノスカプセル2.5mg, ソホノスカプセル5mg, ソホノスカプセル10mg
Nonproprietary names パロバロテン
Companies 製造販売元/IPSEN株式会社
Product type Prescription drug
Therapeutic category レチノイン酸受容体γ作動薬
Therapeutic category codes 873999
YJ codes 3999069M1023, 3999069M2020, 3999069M3026, 3999069M4022, 3999069M5029
Approval numbers 30800AMX00076000, 30800AMX00077000, 30800AMX00078000, 30800AMX00079000, 30800AMX00080000
Package insert edition 第3版
Package insert date Aug 28, 2026
PMDA document key 151077_3999069M1023_1
PMDA company code 151077

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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)