On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma. The company that applied for authorisation is Celgene Europe Ltd. The applicant requested a re‑examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Therapeutic Indication
N/A
Therapeutic Area (MeSH)
ATC Code
L01XX39
ATC Item
xl 01 xx 39
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| romidepsin | N/A | 罗米地辛 |
EMA Name
Istodax
Medicine Name
Istodax
Aliases
N/ANo risk management plan link.
