Fortovase
Withdrawn
This medicine's authorisation has been withdrawn
saquinavir
Medicine
Human
Withdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 20 August 1998 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Fortovase, soft gel capsules, intended for the treatment of HIV-1infected adult patients. Fortovase should only be given in combination with ritonavir and other antiretroviral medicinal products.
On 17 May 2006, the European Commission was notified by Roche Registration Limited of their decision to voluntarily withdraw the marketing authorisation for Fortovase for commercial reasons.
Therapeutic alternatives are available throughout the European Union, including Invirase, the 200 mg hard capsule and 500 mg film-coated tablet formulations of saquinavir as a mesylate salt. On 27 June 2006 the European Commission issued a decision to withdraw the marketing authorisation for Fortovase.
Pursuant to this decision the European Public Assessment Report for Fortovase has been removed from the EMA website.
The Marketing Authorisation Holder for Fortovase continues to be responsible for any remaining product on the market until the expiry date (January 2007) of the latest released batch in the European Union.
Product information
20/08/1998
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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
- Fortovase
- Active substance
- saquinavir
- International non-proprietary name (INN) or common name
- saquinavir
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AE01
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Fortovase is indicated for treatment of HIV-1 infected adult patients. Fortovase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).
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