Salcatonin(Salmon Calcitonin)

Generic Name: Salcatonin(Salmon Calcitonin)

Brand Names: Calcimar, Fortical, Miacalcin

Drug Type: Biotech

CAS Number: 47931-85-1

Unique Ingredient Identifier: 7SFC6U2VI5

Overview

Synthetic peptide, 32 residues long formulated as a nasal spray.

Indication

⑴绝经后骨质疏松症，老年骨质疏松症。 ⑵乳癌、肺或肾癌、骨髓瘤和其他恶性肿瘤骨转移所致的大量骨溶解和高钙血症。 ⑶各种骨代谢疾病所致的骨痛。 ⑷甲状旁腺功能亢进、缺乏活动或维生素D中毒（包括急性或慢性中毒）所致的变应性骨炎。 ⑸Paget病。 ⑹高钙血症和高钙血症危象。

Associated Conditions

Hypercalcemia
Osteoporosis
Paget’s Disease
Symptomatic Paget's disease

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries	2019/01/23	NCT03812991	Phase 4	Completed	University of Missouri-Columbia
A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women	2008/12/05	NCT00803686	Phase 2	Completed	Tarsa Therapeutics, Inc.
Calcitonin in the Treatment of Fibromyalgia	2008/09/18	NCT00754884	Phase 4	Withdrawn	Unidad de Investigacion en Enfermedades Cronico-Degenerativas
A Study for Patients With Osteoporosis	2006/12/22	NCT00414973	Phase 3	Completed	Eli Lilly and Company
Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women	2006/09/06	NCT00372099	Phase 3	Completed	Rene Rizzoli
Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women	2005/10/17	NCT00239889	Phase 4	Completed	Novartis

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Calcitonin Salmon	Apotex Corp.	60505-0823	NASAL	200 [iU] in 1 1	12/13/2023
Calcitonin Salmon	Hikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals)	24201-400	INTRAMUSCULAR, SUBCUTANEOUS	200 [USP'U] in 1 mL	1/10/2023
Miacalcin	Mylan Institutional LLC	72078-039	INTRAMUSCULAR, SUBCUTANEOUS	200 [USP'U] in 1 mL	8/15/2021
Miacalcin	Mylan Institutional LLC	72078-038	INTRAMUSCULAR, SUBCUTANEOUS	200 [USP'U] in 1 mL	8/15/2021
CALCITONIN SALMON	Physicians Total Care, Inc.	54868-6323	NASAL	200 [iU] in 0.09 mL	12/12/2011
CALCITONIN SALMON	Par Pharmaceutical, Inc.	49884-161	NASAL	200 [iU] in 0.09 mL	3/30/2019
Fortical	Physicians Total Care, Inc.	54868-5499	NASAL	2200 [iU] in 1 mL	9/3/2010
Calcitonin Salmon	Par Pharmaceutical, Inc.	42023-205	INTRAMUSCULAR, SUBCUTANEOUS	200 [iU] in 1 mL	11/22/2021
Miacalcin	Mylan Institutional LLC	67457-675	INTRAMUSCULAR, SUBCUTANEOUS	200 [USP'U] in 1 mL	7/18/2018
Calcitonin Salmon	Bryant Ranch Prepack	72162-2128	NASAL	200 [iU] in 1 1	9/19/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MIACALCIC NASAL 200 200 iu/dose	Delpharm Huningue S.A.S	SIN10214P	SPRAY	200 iu/dose	10/8/1998
MIACALCIC INJECTION 50 iu/ml	Solupharm Pharmazeutische GMbH, Novartis Pharma Stein AG	SIN04736P	INJECTION	50 IU/ml	6/26/1990
MIACALCIC INJECTION 100 iu/ml	Solupharm Pharmazeutische Erzeugnisse GmbH, Novartis Pharma Stein AG	SIN04735P	INJECTION	100 iu/ml	6/26/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MIACALCIC calcitonin salmon (salcatonin) 50IU/1mL injection ampoule	13364	Chiesi Australia Pty Ltd	Medicine	A	8/21/1991
Miacalcic 100IU/1mL injection ampoule	13363	Chiesi Australia Pty Ltd	Medicine	A	8/21/1991
MIACALCIC NASAL SPRAY 200IU calcitonin salmon (salcatonin) 2200IU/mL spray bottle	76768	Chiesi Australia Pty Ltd	Medicine	A	11/21/2000

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MIACALCIN NASAL SPRAY 200 IU	novartis pharmaceuticals canada inc	02240775	Spray - Nasal	200 UNIT / ACT	9/8/1999
APO-CALCITONIN INJECTABLE	Apotex Inc	02246058	Liquid - Intramuscular , Subcutaneous	200 UNIT / ML	5/1/2003
MIACALCIN INJECTION 200IU/ML	novartis pharmaceuticals canada inc	02144301	Liquid - Intravenous , Subcutaneous , Intramuscular	200 UNIT / ML	N/A
SANDOZ-CALCITONIN NS	Sandoz Canada, Inc.	02261766	Liquid - Nasal	200 UNIT / SPRAY	12/1/2004
CALCIMAR	sanofi-aventis canada inc	01926691	Solution - Subcutaneous , Intramuscular	200 UNIT / ML	12/31/1983
CALTINE INJ 100UNIT/ML (0.5ML AMP)	Ferring Inc	01940376	Liquid - Subcutaneous , Intramuscular	100 UNIT / ML	12/31/1993
CALTINE INJ 100 UNIT/ML (1ML AMP)	Ferring Inc	02007134	Liquid - Intramuscular , Subcutaneous	100 UNIT / ML	12/31/1993
APO-CALCITONIN NASAL SPRAY	Apotex Inc	02247585	Solution - Nasal	200 UNIT / SPRAY	9/12/2003
CALCITONIN SALMON INJECTION USP	Sterimax Inc	02383233	Solution - Subcutaneous , Intramuscular	200 UNIT / ML	N/A
PRO-CALCITONIN - 200	PRO DOC LIMITEE	02311046	Solution - Nasal	200 UNIT / SPRAY	7/4/2008

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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