Alpheon

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interferon alfa-2a

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 28 June 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Alpheon 6 million IU/ml solution for injection intended for the treatment of hepatitis C. The company that applied for authorisation is BioPartners GmbH. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

This EPAR was last updated on 28/06/2006

Application details

Product details
Name
Alpheon
Active substance
recombinant human interferon alfa-2a
International non-proprietary name (INN) or common name
interferon alfa-2a
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
L03AB04
BiosimilarBiosimilar

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.

Application details
Marketing-autorisation applicant
BioPartners GmbH
Date of opinion
28/06/2006
Date of refusal of marketing authorisation
05/09/2006

Assessment history

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