Pediatric HIV drug approved by EU committee

Article

A child-size dose of an HIV drug is one step closer to being available in Europe...

A child-size dose of an HIV drug is one step closer to being available in Europe.

The drug, Abbott's lopinavir/ritonavir (Kaletra), is already available in an adult dose of 200 mg/50 mg, respectively. The halved pediatric dose, 100 mg/25 mg, has already been approved by FDA.

The EU's Committee for Medicinal Products of Human Use, which works with the World Health Organization, approved the new dosage. The approval brings with its a Certificate of Pharmaceutical Product, which lets the new dosage to be approved in many developing countries. Abbott markets Kaletra at a reduced price in developing countries as Aluvia.

Both the old and new dosages do not need refrigeration, and can be taken with or without food. EMEA (European Medicines Agency) approval of the drug is expected within 90 days.

Newsletter

Access practical, evidence-based guidance to support better care for our youngest patients. Join our email list for the latest clinical updates.

Recent Videos
David Brousseau, MD, highlights impact of timely opioid dosing in pediatric sickle cell pain
August's FDA Focus: Approvals and pipeline updates in pediatrics | Image credit: Contemporary Pediatrics
© 2025 MJH Life Sciences

All rights reserved.