PMDA · MHLW · monthly list
All drugs approved in Japan in November 2024, in English.
Last updated: 2026-10-02 · 8 approvals
Japan approved 8 drugs in November 2024 (approval date: 2024-11-22): 5 new dosage, 3 new indication.
| Approved | Brand | Generic (INN) | Company | Indication | Approval type | FDA date | EMA date | Lag vs FDA | Lag vs EMA | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-11-22 | Romiplate ロミプレート | Romiplostim ロミプロスチム(遺伝子組換え) | Kyowa Kirin Co., Ltd. 協和キリン(株) | Treatment of chronic idiopathic thrombocytopenic purpura 慢性特発性血小板減少性紫斑病 | New dosage standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2024-11-22 | Rituxan リツキサン | Rituximab リツキシマブ(遺伝子組換え) | Zenyaku Kogyo Co., Ltd. 全薬工業(株) | Treatment of chronic idiopathic thrombocytopenic purpura 慢性特発性血小板減少性紫斑病 | New dosage standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2024-11-22 | Revolade レボレード | Eltrombopag olamine エルトロンボパグ オラミン | Novartis Pharma K.K. ノバルティスファーマ(株) | Treatment of chronic idiopathic thrombocytopenic purpura 慢性特発性血小板減少性紫斑病 | New dosage standardpublic-knowledge | — | — | — | — | [1] [2] [3] |
| 2024-11-22 | Randa ランダ | Cisplatin シスプラチン | Nippon Kayaku Co., Ltd. 日本化薬(株) | Treatment of cervical cancer 子宮頸癌 | New dosage standard | — | — | — | — | [1] [2] [3] |
| 2024-11-22 | Lynparza リムパーザ | Olaparib オラパリブ | AstraZeneca K.K. アストラゼネカ(株) | Maintenance therapy of advanced or recurrent endometrial cancer with proficient mismatch repair (pMMR) in patients who have received chemotherapy including treatment with durvalumab (genetical recombination) ミスマッチ修復機能正常(pMMR)の進行・再発の子宮体癌におけるデュルバルマブ(遺伝子組換え)を含む化学療法後の維持療法 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-11-22 | Keytruda キイトルーダ | Pembrolizumab ペムブロリズマブ(遺伝子組換え) Orphan | MSD K.K. MSD(株) | Treatment of locally advanced cervical cancer 局所進行子宮頸癌 | New indication orphanpriority | — | — | — | — | [1] [2] [3] |
| 2024-11-22 | Imfinzi イミフィンジ | Durvalumab デュルバルマブ(遺伝子組換え) | AstraZeneca K.K. アストラゼネカ(株) | Treatment of advanced or recurrent endometrial cancer 進行・再発の子宮体癌 | New indication standard | — | — | — | — | [1] [2] [3] |
| 2024-11-22 | Arexvy アレックスビー | Recombinant respiratory syncytial virus PreF3 antigen RSウイルスPreF3抗原 | GlaxoSmithKline K.K. グラクソ・スミスクライン(株) | Prevention of disease caused by RS virus infection in individuals aged 50 years or older who are considered to be at a high risk of developing severe RS virus infection 50歳以上のRSウイルスによる感染症が重症化するリスクが高いと考えられる者におけるRSウイルスによる感染症の予防 | New dosage standard | — | — | — | — | [1] [2] [3] |
Click a column header to sort. Lag = days between the FDA (or EMA) approval and the Japanese approval of the same active ingredient; “Japan first” means Japan approved it earlier. Lag is shown only when a matching foreign approval was found. JP = no English name found; Japanese kept.
Source: PMDA / MHLW (PDL1.0). Unofficial English translation, edited by Japan Pharma Regulatory Brief.
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