Solumarv

insulin human

Opinion

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.

Key facts

Name
Solumarv
Agency product number
EMEA/H/C/003858
International non-proprietary name (INN) or common name
  • insulin human
Active substance
  • insulin human
Therapeutic area
Diabetes Mellitus
Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Date opinion adopted
19/11/2015
Company name
Marvel Lifesciences Ltd
Status
Negative
Application type
Initial authorisation

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