Forcaltonin

Withdrawn

This medicine's authorisation has been withdrawn

recombinant salmon calcitonin

Overview

The marketing authorisation for Forcaltonin has been withdrawn at the request of the marketing authorisation holder.

Forcaltonin : EPAR - Summary for the public

Product information

Forcaltonin : EPAR - 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).

Forcaltonin : EPAR - All Authorised presentations

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 homeostasis

Therapeutic 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

Changes since initial authorisation of medicine

Forcaltonin : EPAR - Procedural steps taken and scientific information after authorisation

Forcaltonin : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Forcaltonin : EPAR - Scientific Discussion

Forcaltonin : EPAR - Procedural steps taken before authorisation