Opinions on medicines for use outside the European Union
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.
Summary of opinion
Public assessment reports
- Aluvia (lopinavir / ritonavir)
- Fexinidazole Winthrop (fexinidazole)
- Mosquirix (Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted))
- Pyramax (pyronaridine / artesunate)
- Umbipro (chlorhexidine)
Withdrawals of application
- Globorix (vaccine against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and Neisseria meningitidis groups A and C)
- Hemoprostol (misoprostol)
- Hexaxim (diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed))
- Lamivudine ViiV (lamivudine)
- Lamivudine / Zidovudine ViiV (lamivudine / zidovudine)
- Tritanrix HB (diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed))