Is Sirolimus registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Sirolimus, including RAPAMUNE 1 MG Coated tablet (1 mg, Coated tablet, SAR 371.90); Sirolimus BOS (1 mg, Film-coated tablet, SAR 1157.10); Sirolimus BOS (2 mg, Film-coated tablet, SAR 2314.20); Siromune (1 mg/ml, Oral solution, SAR 1199.65); sirolimus (1 mg/ml, Oral solution, SAR 1020.95).

Is Sirolimus approved by the US FDA?

Drugs@FDA lists 17 application product lines for Sirolimus, including RAPAMUNE (Prescription); RAPAMUNE (Prescription); SIROLIMUS (Prescription); SIROLIMUS (Prescription); SIROLIMUS (Prescription).

Is Sirolimus authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Sirolimus: Rapamune, Hyftor.

Are there safety signals or safety updates for Sirolimus?

US FDA: 3 entries; MHRA: 1 entry (latest 2026-09-02).

Active substance

Sirolimus

SFDA 5
US FDA 17
EMA 3
Health Canada 2
US price lines 4
NHS prices 5
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
RAPAMUNE 1 MG Coated tablet	1 mg	Coated tablet · Oral use	30 Blister	SAR 371.90	Generic · Prescription	Pfizer Europe MA EEIG	Valid
Sirolimus BOS	1 mg	Film-coated tablet · Oral use	100 Bottle	SAR 1157.10	Generic · Prescription	Boston Oncology Arabia	Valid
Sirolimus BOS	2 mg	Film-coated tablet · Oral use	100 Bottle	SAR 2314.20	Generic · Prescription	Boston Oncology Arabia	Valid
Siromune	1 mg/ml	Oral solution · Oral use	1 Bottle	SAR 1199.65	Generic · Prescription	Saudi Amarox	Valid
sirolimus	1 mg/ml	Oral solution · Oral use	1 Bottle	SAR 1020.95	Generic · Prescription	VistaPharma,Inc	Valid

Indications — CHI Daman Drug Formulary

AUTOIMMUNE HEPATITIS; GRAFT VERSUS HOST DISEASE; RENAL TRANSPLANT

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

Product	Strength	Form · route	Applicant	Status	First approved
RAPAMUNE	1MG/ML	solution · oral	PF PRISM CV	Prescription	15 Sep 1999
RAPAMUNE	1MG; 2MG; 0.5MG	tablet · oral	PF PRISM CV	Prescription	25 Aug 2000
SIROLIMUS	1MG; 2MG; 0.5MG	tablet · oral	ZYDUS PHARMS	Prescription	8 Jan 2014
SIROLIMUS	1MG; 2MG	tablet · oral	DR REDDYS	Prescription	27 Oct 2014
SIROLIMUS	1MG/ML	solution · oral	NOVITIUM PHARMA	Prescription	28 Jan 2019
SIROLIMUS	1MG/ML	solution · oral	AMNEAL	Prescription	18 Oct 2019
SIROLIMUS	1MG/ML	solution · oral	APOTEX	Prescription	22 Oct 2019
SIROLIMUS	0.5MG; 1MG; 2MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	16 Oct 2020
SIROLIMUS	0.5MG; 1MG; 2MG	tablet · oral	ALKEM LABS LTD	Prescription	12 Mar 2021
FYARRO	100MG/VIAL	powder · intravenous	AADI	Prescription	22 Nov 2021
HYFTOR	0.2%	gel · topical	NOBELPHARMA	Prescription	22 Mar 2022
SIROLIMUS	1MG/ML	solution · oral	MSN	Prescription	19 Jan 2023
SIROLIMUS	1MG/ML	solution · oral	HETERO LABS LTD V	Prescription	16 Sep 2024
SIROLIMUS	1MG/ML	solution · oral	RISING	Prescription	15 Jul 2025
SCOMARA	0.5% sirolimus in 30g tube	cream · topical	AFT PHARMACEUTICALS LTD	Prescription
RAPAMUNE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	PF PRISM CV	Discontinued	25 Aug 2000
SIROLIMUS	1MG/ML	solution · oral	TORRENT	Discontinued	27 Dec 2021

EMA European Union — centrally authorised medicines

Rapamune Pfizer Europe MA EEIG · Authorised · authorised 13 Mar 2001 · ATC L04AH01

Therapeutic indication (EMA)

Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.

Hyftor Plusultra pharma GmbH · Authorised · authorised 15 May 2023

Therapeutic indication (EMA)

Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

Opsiria Santen Oy · Application withdrawn · ATC S01XA23

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
RAPAMUNE	02243237	1 MG / ML	SOLUTION · ORAL	PFIZER CANADA ULC
RAPAMUNE	02247111	1 MG	TABLET · ORAL	PFIZER CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SIROLIMUS 0.5 MG TABLET	$0.84147	per EA	23 Sep 2026
US NADAC	SIROLIMUS 1 MG TABLET	$0.72296	per EA	23 Sep 2026
US NADAC	SIROLIMUS 1 MG/ML SOLUTION	$4.39032	per ML	23 Sep 2026
US NADAC	SIROLIMUS 2 MG TABLET	$2.5288	per EA	23 Sep 2026
NHS Drug Tariff	Sirolimus 1mg tablets	£86.49	30 tablet	1 Oct 2026
NHS Drug Tariff	Sirolimus 1mg/ml oral solution sugar free	£162.41	60 ml	1 Oct 2026
NHS Drug Tariff	Sirolimus 2mg tablets	£172.98	30 tablet	1 Oct 2026
NHS Drug Tariff	Sirolimus 2mg/g gel	£340.00	10 gram	1 Oct 2026
NHS Drug Tariff	Sirolimus 500microgram tablets	£69.00	30 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 2 Sep 2026 FYARRO — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations
US FDA 22 Aug 2022 RAPAMUNE — 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
US FDA 22 Aug 2022 RAPAMUNE — 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
MHRA 11 Dec 2014 Sirolimus: different immunoassays for therapeutic drug monitoring—risk of incorrect dose adjustment
Needs a summary

All safety entries for sirolimus →

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.