Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Forcaltonin
Auth. number : EU/1/98/093
Active substance : Calcitonin (salmon)
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H05 - Calcium homeostasis
Pharmacological subgroup: H05B - Anti-parathyroid hormones
Chemical subgroup: H05BA - Calcitonin preparations
Chemical substance: H05BA01 - calcitonin (salmon synthetic)
(See WHO ATC Index)
Indication: Treatment of Paget´s disease and hypercalcemia in malignancy
Marketing Authorisation Holder: Unigene UK Limited
191 Sparrows Herne, Bushey Heath, Hertfordshire WD23 1AJ, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
15/01/1999 Centralised - Authorisation EMEA/H/C/197 (1999)39 of 11/01/1999
11/06/1999 Centralised - Notification EMEA/H/C/197/N/1 (1999)1493 of 03/06/1999
07/08/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/197/I/6, 7
04/09/2000 Centralised - Variation EMEA/H/C/197/I/4 (2000)2540 of 28/08/2000
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/197/I/3
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/197/I/5
19/12/2000 Centralised - Notification EMEA/H/C/197/N/8 (2000)3512 of 18/12/2000
18/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/197/II/9
16/06/2003 Centralised - Variation EMEA/H/C/197/II/2 (2003)1889 of 11/06/2003
29/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/197/I/10
16/04/2004 Centralised - Renewal EMEA/H/C/197/R/11 (2004)1468 of 14/04/2004
06/07/2005 Centralised - Variation EMEA/H/C/197/II/13 (2005)2568 of 04/07/2005
19/10/2005 Centralised - Variation EMEA/H/C/197/IA/15
Updated with Decision(2006)1967 of 10/05/2006
16/05/2006 Centralised - Variation (2006)1967 of 10/05/2006
03/11/2008 Centralised - Withdrawal (2008)6529 of 29/10/2008