Is Fulvestrant registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Fulvestrant, including Ambiful 250 mg per 5 ml (50 mg/ml, Solution for injection, SAR 855.55); Carcivor 250 mg per 5 ml (50 mg/ml, Solution for injection, SAR 1237.10); Floristil 250 mg per 5 ml (50 mg/ml, Solution for injection, SAR 1256.55); Fultra (5 %, Solution for injection in pre-filled syringe, SAR 1237.10); Fulvestrant SPC (50 mg/ml, Solution for injection, SAR 925.90).

Is Fulvestrant approved by the US FDA?

Drugs@FDA lists 19 application product lines for Fulvestrant, including FASLODEX (Prescription); FULVESTRANT (Prescription); FULVESTRANT (Prescription); FULVESTRANT (Prescription); CLIGAVYX (Prescription).

Is Fulvestrant authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Fulvestrant: Faslodex, Fulvestrant Mylan.

Are there safety signals or safety updates for Fulvestrant?

EMA PRAC: 3 entries; US FDA: 2 entries (latest 2025-11-21).

Active substance

Fulvestrant

SFDA 7
US FDA 19
EMA 2
Health Canada 6
NHS prices 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Ambiful 250 mg per 5 ml	50 mg/ml	Solution for injection · Intramuscular use	2 Pre-filled syringe	SAR 855.55	Generic · Prescription	EVER Valinject GmbH	Valid
Carcivor 250 mg per 5 ml	50 mg/ml	Solution for injection · Intramuscular use	2 Pre-filled syringe	SAR 1237.10	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Floristil 250 mg per 5 ml	50 mg/ml	Solution for injection · Intravenous use	2 Pre-filled syringe	SAR 1256.55	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Fultra	5 %	Solution for injection in pre-filled syringe · Intramuscular use	2 Pre-filled syringe	SAR 1237.10	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Fulvestrant SPC	50 mg/ml	Solution for injection · Intramuscular use	2 Pre-filled syringe	SAR 925.90	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Fuxran	50 mg/ml	Solution for injection · Intramuscular use	2 Pre-filled syringe	SAR 1361.25	Generic · Prescription	Sandoz Pharmaceuticals	Valid
Strontava	50 mg	Solution for injection in pre-filled syringe · Intramuscular use	0 Pre-filled syringe	SAR 1256.55	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HORMONAL

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

Product	Strength	Form · route	Applicant	Status	First approved
FASLODEX	250MG/5ML (50MG/ML)	solution · intramuscular	ASTRAZENECA	Prescription	25 Apr 2002
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	AMNEAL	Prescription	4 Mar 2019
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	SANDOZ	Prescription	14 May 2019
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	FRESENIUS KABI USA	Prescription	20 May 2019
CLIGAVYX	250MG/5ML (50MG/ML)	solution · intramuscular	AVYXA HOLDINGS	Prescription	19 Aug 2019
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	SAGENT PHARMS INC	Prescription	22 Aug 2019
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	GLENMARK PHARMS	Prescription	22 Aug 2019
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	HBT LABS INC	Prescription	21 Nov 2019
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	CHIA TAI TIANQING	Prescription	7 Feb 2020
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	DR REDDYS	Prescription	7 Aug 2020
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	ACCORD HLTHCARE	Prescription	17 Nov 2020
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	ZYDUS PHARMS	Prescription	29 Jul 2021
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	XIROMED	Prescription	13 Aug 2021
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	JIANGSU HANSOH PHARM	Prescription	10 Feb 2022
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	ALEMBIC	Prescription	22 Dec 2022
FASLODEX	125MG/2.5ML (50MG/ML)	solution · intramuscular	ASTRAZENECA	Discontinued	25 Apr 2002
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	EUGIA PHARMA	Discontinued	23 Jul 2019
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	APOTEX	Discontinued	11 Jun 2021
FULVESTRANT	250MG/5ML (50MG/ML)	solution · intramuscular	EUGIA PHARMA	Discontinued	30 Jun 2023

EMA European Union — centrally authorised medicines

Faslodex AstraZeneca AB · Authorised · authorised 9 Mar 2004 · ATC L02BA03

Therapeutic indication (EMA)

Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

Fulvestrant Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 8 Jan 2018 · ATC L02BA03

Therapeutic indication (EMA)

Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FASLODEX	02248624	250 MG / 5 ML	SOLUTION · INTRAMUSCULAR	ASTRAZENECA CANADA INC
FULVESTRANT INJECTABLE	02530635	250 MG / 5 ML	SOLUTION · INTRAMUSCULAR	JAMP PHARMA CORPORATION
FULVESTRANT INJECTION	02483610	250 MG / 5 ML	SOLUTION · INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
FULVESTRANT INJECTION	02536293	250 MG / 5 ML	SOLUTION · INTRAMUSCULAR	FORMATIVE PHARMA INC.
FULVESTRANT INJECTION	02558971	250 MG / 5 ML	SOLUTION · INTRAMUSCULAR	STERIMAX INC
TEVA-FULVESTRANT INJECTION	02460130	250 MG / 5 ML	SOLUTION · INTRAMUSCULAR	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Fulvestrant 250mg/5ml solution for injection pre-filled syringes	£522.41	2 pre-filled disposable injection	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 21 Nov 2025 FULVESTRANT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 13 May 2020 FASLODEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Jul 2017 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: Yes
EMA PRAC 9 Mar 2017 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No
EMA PRAC 14 Apr 2016 PRAC signal: Interference with oestradiol assay leading to false oestradiol results
Action for MAH: update of the product information: No

All safety entries for fulvestrant →

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.