Adlumiz

Unknown🇪🇺 European Union

EMA Page

Authorised Date: N/A
Approval ID: a331c05298bd0199
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Adlumiz, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non\-small cell lung cancer. The company that applied for authorisation is Helsinn Birex Pharmaceuticals Ltd. The company requested a re\-examination of the initial opinion. After considering the grounds for this request, the CHMP re\-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017\.

Therapeutic & Classification

Therapeutic Indication

N/A

Therapeutic Area (MeSH)

Cachexia

Anorexia

Carcinoma, Non-Small-Cell Lung

ATC Code

V03

ATC Item

N/A

Pharmacotherapeutic Group

All other therapeutic products

Active Substances

Active Substance (Summary)

anamorelin hydrochloride

INN / Common Names

anamorelin

Active Substance Details

Active substance details are not yet available.

Quick Info

Approval IDa331c05298bd0199

Product NumberN/A

StatusAuthorised

Authorised DateN/A

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Adlumiz

Medicine Name

Adlumiz

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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