Solumarv

Unknown🇪🇺 European Union

EMA Page

Authorised Date: N/A
Approval ID: 1e9198c36aa8fef5
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorisation for the medicinal product Solumarv, intended for the treatment of diabetes. The company that applied for authorisation is Marvel Lifesciences Ltd. It can request a re\-examination of the opinion within 15 days of receipt of notification of this negative opinion.

Therapeutic & Classification

Therapeutic Indication

N/A

Therapeutic Area (MeSH)

Diabetes Mellitus

ATC Code

A10AB01

ATC Item

N/A

Pharmacotherapeutic Group

N/A

Active Substances

Active Substance (Summary)

insulin human

INN / Common Names

insulin human

Active Substance Details

Active substance details are not yet available.

Quick Info

Approval ID1e9198c36aa8fef5

Product NumberN/A

StatusAuthorised

Authorised DateN/A

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Solumarv

Medicine Name

Solumarv

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.

Back to EMA Approvals