Is Temsirolimus 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 Temsirolimus.

Is Temsirolimus approved by the US FDA?

Drugs@FDA lists 3 application product lines for Temsirolimus, including TORISEL (Prescription); TEMSIROLIMUS (Prescription); TEMSIROLIMUS (Prescription).

Is Temsirolimus authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Temsirolimus: Torisel.

Are there safety signals or safety updates for Temsirolimus?

EMA PRAC: 1 entry; US FDA: 1 entry; MHRA: 1 entry (latest 2018-03-23).

Active substance

Temsirolimus

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

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TORISEL 25MG/ML CONC. FOR IV INFUSION	25 mg/ml	concentrate for solution for injection · Parenteral use	1 Vial	SAR 4487.90	NCE · Prescription	WYETH	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
TORISEL	25MG/ML (25MG/ML)	solution · intravenous	PF PRISM CV	Prescription	30 May 2007
TEMSIROLIMUS	25MG/ML (25MG/ML)	solution · intravenous	ACCORD HLTHCARE	Prescription	30 Jul 2018
TEMSIROLIMUS	25MG/ML (25MG/ML)	solution · intravenous	GLAND	Prescription	16 Aug 2019

EMA European Union — centrally authorised medicines

Torisel Pfizer Europe MA EEIG · Authorised · authorised 19 Nov 2007 · ATC L01XE09

Therapeutic indication (EMA)

Renal-cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors. Mantle-cell lymphoma Torisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TORISEL	02304104	25 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 23 Mar 2018 TORISEL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Apr 2015 PRAC signal: Myocardial infarction
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Temsirolimus: severe hypersensitivity reactions during infusion
Severe infusion-related hypersensitivity reactions have occurred in patients receiving temsirolimus.

All safety entries for temsirolimus →

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.