Nelfinavir non-renewal of marketing authorisation in the EU

The marketing authorisation for nelfinavir (Viracept) ended on 23 January 2013 and is no longer valid in the EU. [1]

This was expected, as last year, manufacturers in the EU, Roche Pharmaceuticals, announced that it was not going to reapply. The original authorisation was granted in January 1998 and was subsequently renewed for additional 5-year periods in 2003 and 2008.

Despite having reduced potency compared to other protease inhibitors, nelfinavir was once widely prescribed and did not require ritonavir boosting. Although a paediatric formulation was available, the volume of powder required for reconstitution limited its use by children. However, nelfinavir was the only available protease inhibitor in many countries, until reduced price heat-stable lopinavir/ritonavir (Aluvia) was launched in 2006.

The dramatically reduced use was not helped by a manufacturing problem that resulted in product recall and a brief discontinuation of supply in 2007. [2]


  1. EMA. Viracept: Non-renewal of the marketing authorisation in the European Union. (23 January 2013).
  2. See HTB. Roche recalls nelfinavir (Viracept) due to chemical impurity. July 2007.

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