Is Parathyroid hormone approved by the US FDA?

Drugs@FDA lists 1 application product line for Parathyroid hormone, including NATPARA (Prescription).

Is Parathyroid hormone authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Parathyroid hormone.

Are there safety signals or safety updates for Parathyroid hormone?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2020-07-01).

Active substance

Parathyroid hormone

US FDA 1
EMA 2
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NATPARA	25MCG; 50MCG; 75MCG; 100MCG	injectable · injection	NPS PHARMS INC	Prescription	23 Jan 2015

EMA European Union — centrally authorised medicines

Preotact NPS Pharma Holdings Limited · Withdrawn · authorised 24 Apr 2006 · ATC H05AA03

Therapeutic indication (EMA)

Treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1). A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

Natpar Takeda Pharmaceuticals International AG Ireland Branch · Withdrawn · authorised 24 Apr 2017 · ATC H05AA03

Therapeutic indication (EMA)

Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.

Safety signals and safety-related labeling changes

US FDA 1 Jul 2020 NATPARA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Apr 2018 PRAC signal: Nephrolithiasis
Action for MAH: update of the product information: No

All safety entries for parathyroid hormone →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.