Opinions on medicines for use outside the European Union

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This page lists the opinions given by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), in co-operation with the World Health Organization (WHO), on medicines for human use that are intended exclusively for markets outside of the European Union (EU).

Medicines eligible for this procedure are used to prevent or treat diseases of major public-health interest. These include vaccines used in the WHO Expanded Programme on Immunization or for protection against a public-health priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria, or tuberculosis.

These opinions are given in accordance with Article 58 of Regulation (EC) No 726/2004.

Public assessment reports

Withdrawals of application


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Article 58