Japan· JP-4291427A2020
ニボルマブ（遺伝子組換え）
A medicinal product containing ニボルマブ（遺伝子組換え）, registered in Japan by 小野薬品工業, on the national reimbursement list.
Checked against MHLW / PMDA (Japan) on
Informational only — not a medical device.
The record
At a glance
MHLW / PMDA (Japan)- Active substance
- ニボルマブ（遺伝子組換え）
- Manufacturer
- 小野薬品工業
- Country
- Japan (JP)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- MHLW / PMDA (Japan)
- Last checked
- September 25, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
ニボルマブ（遺伝子組換え） in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainOPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSIONBristol-Myers Squibb Pharma Eeig
- United KingdomNivolumab BMS 100mg/10ml concentrate for solution for infusion vialsBristol-Myers Squibb Pharmaceuticals Ltd
- United StatesOPDIVOE.R. Squibb & Sons, L.L.C.
- FinlandNivolumab BmsBristol-Myers Squibb Pharma EEIG
- BelgiumOpdivo 10 mg/mlBristol-Myers Squibb Pharma
- CzechiaOPDIVOBristol-Myers Squibb Pharma EEIG, Dublin
- SwitzerlandOpdivo 100 mg/10 ml, Konzentrat zur Herstellung einer InfusionslösungBristol-Myers Squibb SA
- IcelandOpdivoBristol-Myers Squibb Pharma EEIG*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Opdivo
- Liechtenstein · Opdivo
- Norway · Opdivo
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of MHLW / PMDA (Japan). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/89465cac-a86c-430d-ad41-ed4247f8747e GET /v1/drugs/89465cac-a86c-430d-ad41-ed4247f8747e?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"spec": "１００ｍｇ１０ｍＬ１瓶",
"marks": null,
"source": "mhlw",
"remarks": null,
"yj_code": "4291427A2020",
"category": "注射薬",
"price_yen": 131811,
"generic_name": "ニボルマブ（遺伝子組換え）",
"product_name_jp": null,
"therapeutic_class": "4291",
"transitional_expiry": null
}See everything about ニボルマブ（遺伝子組換え）.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.