Forcaltonin
Withdrawn
This medicine's authorisation has been withdrawn
recombinant salmon calcitonin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 1 October 2008, the marketing authorisation holder (MAH) responsible for Forcaltonin, Unigene UK Ltd, notified the European Commission of its decision to voluntarily withdraw the marketing authorisation for Forcaltonin for commercial reasons.
The MAH confirmed that this decision is not related to any safety concerns with Forcaltonin. Forcaltonin (recombinant salmon calcitonin) was indicated for the prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures, Paget’s disease and hypercalcaemia of malignancy. Alternative treatments containing the same active substance as Forcaltonin (salmon calcitonin) are available throughout the European Union. On 29 October 2008, the European Commission issued a decision to withdraw the marketing authorisation for Forcaltonin.
Pursuant to this decision, the European public assessment report (EPAR) for Forcaltonin is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IA/0015
20/11/2008
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Forcaltonin
- Active substance
- recombinant salmon calcitonin
- International non-proprietary name (INN) or common name
- recombinant salmon calcitonin
- Therapeutic area (MeSH)
- Hypercalcemia
- Osteitis Deformans
- Bone Resorption
- Anatomical therapeutic chemical (ATC) code
- H05BA01
Pharmacotherapeutic group
Calcium homeostasisTherapeutic indication
Calcitonin is indicated for:
- Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures
- Paget's disease
- Hypercalcaemia of malignancy
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