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
|
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. |
Application details | |
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Marketing-authorisation applicant |
BioPartners GmbH
|
Date of opinion |
28/06/2006
|
Date of refusal of marketing authorisation |
05/09/2006
|
Assessment history
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List item
Questions and answers on the recommendation for the refusal of the marketing authorisation for Alpheon (PDF/29.84 KB)
First published: 22/10/2007
Last updated: 22/10/2007 -
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List item
Alpheon : EPAR - Refusal public assessment report (PDF/195.18 KB)
First published: 22/10/2007
Last updated: 22/10/2007