From their meeting in December, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting, the CHMP announced the recommendations of seven medicines for approval, including two orphan medicines.
A positive opinion was adopted for Rizmoic (naldemedine) for the treatment of opioid-induced constipation, and for Tobramycin PARI (tobramycin). Tobramycin PARI is a hybrid medicine for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged six years and older with cystic fibrosis.
The CHMP recommended extensions of therapeutic indication for Adcetris, Rapiscan, Rubraca, Simponi, Sprycel and Trimbow. Two applications for initial marketing authorisations have been withdrawn; Fyzoclad (adalimumab) and canakinumab Novartis (canakinumab).
Metamizole medicines are marketed in EU Member States for treatment of severe pain and fever that is not controlled with alternative treatments. The CHMP has stated that the maximum daily dose of metamizole and the contraindications to its use in pregnancy or in breastfeeding women should be harmonised for all products on the EU market. The CHMP have also come to the conclusion that omega-3 fatty acid medicines are not effective for the prevention of further heart and blood vessels issues in patients who have had a heart attack.
The CHMP have also started a review of medicines containing the antibiotic fosfomycin, which is currently used in several European Union (EU) Member States to treat a variety of bacterial infections.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.