Raptiva
Withdrawn
This medicine's authorisation has been withdrawn
efalizumab
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 20 September 2004 the European Commission granted a marketing authorisation valid throughout the European Union for the medicinal product Raptiva (efalizumab), indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA.
On 19 February 2009, the Committee for Medicinal Products for Human Use (CHMP) issued an Opinion recommending the suspension of the marketing authorisation for Raptiva in all Member States in which the product was marketed, as its benefits in the treatment of psoriasis were modest, while there was a risk of serious side effects, including the occurrence of progressive multifocal leukoencephalopathy (PML). As a condition for lifting the suspension, the CHMP recommended that new evidence should be provided to identify a subgroup of patients for which the benefits of Raptiva would outweigh the risks. On 12 May 2009, the Marketing Authorisation Holder for Raptiva (Serono Europe Limited) notified the European Commission of its decision to voluntarily withdraw the marketing authorisation for the product, as it did not intend to conduct the clinical trials necessary to fulfil the requirements for lifting the suspension.
On 9 June 2009 the European Commission issued a decision to withdraw the marketing authorisation for Raptiva. Pursuant to this decision the European Public Assessment Report for Raptiva is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0026
25/11/2008
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Raptiva
- Active substance
- efalizumab
- International non-proprietary name (INN) or common name
- efalizumab
- Therapeutic area (MeSH)
- Psoriasis
- Anatomical therapeutic chemical (ATC) code
- L04AA21
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1 - Clinical Efficacy).
Assessment history
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