CHMP Adopts Positive Opinion for Zoledronic Acid

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for Teva Pharma's Zoledronic Acid.

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zoledronic Acid Teva Pharma, 5 mg, solution for infusion intended for the treatment of osteoporosis (in post-menopausal women and in men at increased risk of fracture), treatment of osteoporosis associated with long-term systemic glucocorticoid therapy (in post-menopausal women and in men at increased risk of fracture) and for the treatment of Paget’s disease of the bone in adults.

The applicant for this medicinal product is Teva Pharma B.V. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.