Is Pasireotide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Pasireotide.

Is Pasireotide approved by the US FDA?

Drugs@FDA lists 1 application product line for Pasireotide, including SIGNIFOR LAR KIT (Prescription).

Is Pasireotide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pasireotide: Signifor.

Are there safety signals or safety updates for Pasireotide?

US FDA: 2 entries (latest 2024-07-11).

Active substance

Pasireotide

SFDA 3
US FDA 1
EMA 1
Health Canada 5
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SIGNIFOR 0.3 mg solution for injection	0.3 mg	Solution for injection · Subcutaneous use	60 Ampoule	SAR 21623.55	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
SIGNIFOR 0.6 mg solution for injection	0.6 mg	Solution for injection · Subcutaneous use	60 Ampoule	SAR 21623.55	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
SIGNIFOR 0.9 mg solution for injection	0.9 mg	Solution for injection · Subcutaneous use	60 Ampoule	SAR 21623.55	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
SIGNIFOR LAR KIT	EQ 20MG BASE/VIAL; EQ 40MG BASE/VIAL; EQ 60MG BASE/VIAL; EQ 10MG BASE/VIAL; EQ 30MG BASE/VIAL	for suspension · intramuscular	RECORDATI RARE	Prescription	15 Dec 2014

EMA European Union — centrally authorised medicines

Signifor Recordati Rare Diseases · Authorised · authorised 24 Apr 2012 · ATC H01CB05

Therapeutic indication (EMA)

Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. Signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SIGNIFOR LAR	02437252	20 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE; KIT · INTRAMUSCULAR	RECORDATI RARE DISEASES CANADA INC
SIGNIFOR LAR	02437260	40 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE; KIT · INTRAMUSCULAR	RECORDATI RARE DISEASES CANADA INC
SIGNIFOR LAR	02437279	60 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE; KIT · INTRAMUSCULAR	RECORDATI RARE DISEASES CANADA INC
SIGNIFOR LAR	02480425	10 MG / VIAL	KIT; POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULAR	RECORDATI RARE DISEASES CANADA INC
SIGNIFOR LAR	02480433	30 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE; KIT · INTRAMUSCULAR	RECORDATI RARE DISEASES CANADA INC

Safety signals and safety-related labeling changes

US FDA 11 Jul 2024 SIGNIFOR LAR KIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Jun 2018 SIGNIFOR LAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pasireotide →

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.