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Class 2 Drug Alert (Action Within 48 Hours): Miacalcic 200 IU Nasal Spray Solution – Novartis Pharmaceuticals UK Ltd – EL 13(A)11

Dear Healthcare Professional,

Novartis Pharmaceuticals UK Ltd

Miacalcic 200 IU Nasal Spray Solution

Calcitonin (salmon)

PL 00101/0586
All unexpired stock of this product is being recalled to pharmacy, clinic and wholesaler level irrespective of batch number and expiry date.

The product is being withdrawn throughout the European Union after a study has shown an increased risk of malignancies with the long term use of calcitonin. Both the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee have concluded that the benefits no longer outweigh the risks.

No further Miacalcic 200 IU Nasal Spray Solution should be dispensed. Pharmacists should refer patients with new or repeat prescriptions to the treating physician to review their treatment plan on a non-urgent basis.

G.Mohan