Overview
The marketing authorisation for Forcaltonin has been withdrawn at the request of the marketing authorisation holder.
Forcaltonin : EPAR - Summary for the public
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Product information
Forcaltonin : EPAR - Product Information
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čeština (CS) (564.71 KB - PDF)
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lietuvių kalba (LT) (538.49 KB - PDF)
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português (PT) (479.26 KB - PDF)
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svenska (SV) (472.07 KB - PDF)
Latest procedure affecting product information: IA/0015
20/11/2008
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Forcaltonin : EPAR - All Authorised presentations
English (EN) (272.98 KB - PDF)
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
Authorisation details
- EMA product number
- EMEA/H/C/000197
- Marketing authorisation holder
- Unigene UK Ltd.
Unigene UK Limited
191 Sparrows Herne
Bushey Heath
Hertfordshire WD23 1AJ
United Kingdom - Marketing authorisation issued
- 11/01/1999
Assessment history
Forcaltonin : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (245.4 KB - PDF)
Forcaltonin : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (490.47 KB - PDF)
More information on Forcaltonin
Public statement on Forcaltonin - Withdrawal of the marketing authorisation in the European Union
English (EN) (21.6 KB - PDF)