fulvestrant
Faslodex · ATC code L02BA03
Brand names: Faslodex, Fulvestrant +pharma, Fulvestrant Accord, Fulvestrant Aptapharma, Fulvestrant Ever Pharma, Fulvestrant Ever Valinject, Fulvestrant Ratiopharm, Fulvestrant Ribosepharm, Fulvestrant Sandoz, Fulvestrant Stada, Faslant, Fuxran, Ulvest
- Key facts
- Active substance
- fulvestrant
- Drug class
- Estrogen antagonist
- ATC code
- L02BA03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Faslodex 250 mg solution for injection.
- Marketing authorisation holder
- AstraZeneca AB
- Information as of
- 2026-10-27
Key facts
Fulvestrant is an oestrogen receptor antagonist (Faslodex) given by intramuscular injection. It is used for hormone receptor-positive, locally advanced or metastatic breast cancer, alone or with palbociclib.
What it is used for
- Monotherapy for estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women
- Without prior endocrine therapy, or with relapse/progression on or after antiestrogen therapy
- With palbociclib for HR-positive, HER2-negative advanced breast cancer after prior endocrine therapy
- Pre- or perimenopausal women on the combination also receive an LHRH agonist
Dosing
- 500 mg at intervals of one month, with an additional 500 mg dose two weeks after the initial dose
- Given as two consecutive 5 ml slow intramuscular injections, one in each buttock
- No dose adjustment in mild to moderate renal or hepatic impairment
- Severe renal impairment (creatinine clearance <30 ml/min): caution
Contraindications
- Hypersensitivity to the active substance or any of the excipients
- Pregnancy and lactation
- Severe hepatic impairment
Important warnings
- Caution in mild to moderate hepatic impairment and severe renal impairment
- Caution in bleeding diatheses, thrombocytopenia or anticoagulant treatment (intramuscular route)
- Thromboembolic events
- Injection site sciatica, neuralgia and peripheral neuropathy; caution at the dorsogluteal site near the sciatic nerve
- Potential risk of osteoporosis; interference with estradiol antibody assays
Side effects
- Most frequent (monotherapy): injection site reactions, asthenia, nausea
- Increased hepatic enzymes (ALT, AST, ALP)
- Thromboembolic events
- Sciatica and peripheral neuropathy
Interactions
- Does not inhibit CYP3A4; no clinically relevant change with rifampicin or ketoconazole
- No dose adjustment needed with CYP3A4 inhibitors or inducers
Pregnancy and breastfeeding
- Contraindicated in pregnancy and lactation
- Effective contraception during treatment and for 2 years after the last dose
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- FaslodexAstraZeneca AB · EMEA/H/C/000540
- Fulvestrant Mylan · genericMylan Pharmaceuticals Limited · EMEA/H/C/004649
Source: European Medicines Agency (EMA), product information
Austria
- Fulvestrant +pharma+pharma Arzneimittel Gmbh · 1 register entry
- Fulvestrant AccordAccord Healthcare B.V. · 1 register entry
- Fulvestrant AptapharmaApta Medica Internacional D.O.O. · 1 register entry
- Fulvestrant Ever PharmaEver Valinject Gmbh · 1 register entry
- Fulvestrant Ever ValinjectEver Valinject Gmbh · 1 register entry
- Fulvestrant RatiopharmTeva B.V · 1 register entry
- Fulvestrant RibosepharmHikma Farmacêutica (Portugal), S.A. · 1 register entry
- Fulvestrant SandozSandoz Gmbh · 1 register entry
- Fulvestrant StadaStada Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Fulvestrant1 A Pharma Gmbh, Ever Valinject Gmbh, Ever Neuro Pharma Gmbh, Hikma Farmacêutica (Portugal), S.A., Ratiopharm Gmbh, Medical Valley Invest Ab, Glenmark Arzneimittel Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Onkovis Gmbh, Zentiva Pharma Gmbh, Accord Healthcare B.V., Cipla Europe Nv, Hexal Ag, Eugia Pharma (Malta) Limited, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Aliud Pharma Gmbh · 19 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- FaslantDEVA HOLDİNG A.Ş. · 2 register entries
- FaslodexASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries
- FuxranSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- UlvestTEVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Fulvestrant Accord, Fulvestrant Eugia, Fulvestrant Ever Pharma, Fulvestrant Sandoz, Fulvestrant Teva
- Bulgaria
- Fulvestrant Ever Pharma, Fulvestrant Pharmascience, Fulvestrant Sandoz, Васталома, Лабама, Фулвестрант Ever Pharma, Фулвестрант Акорд, Фулвестрант Ромфарм, Фулвестрант Тева
- Croatia
- Fulvestrant Accord, Fulvestrant Aptapharma, Fulvestrant Ever Pharma, Fulvestrant Pliva, Fulvestrant Sandoz
- Cyprus
- Fulvestrant Accord, Fulvestrant Rompharm
- Czechia
- Fulvestrant Accord, Fulvestrant Ever Pharma, Fulvestrant Sandoz, Fulvestrant Stada, Fulvestrant Teva, Fulvestrant Vipharm
- Denmark
- Fulvestrant "stada", Fulvestrant Accord, Fulvestrant Ever Pharma, Fulvestrant Glenmark, Fulvestrant Medical Valley, Fulvestrant Orion, Fulvestrant Reddy, Fulvestrant Stada Nordic
- Estonia
- Fulvestrant Accord, Fulvestrant Aliud, Fulvestrant Sandoz, Fulvestrant Stada, Fulvestrant Zentiva
- Finland
- Fulvestrant Accord, Fulvestrant Ever Pharma, Fulvestrant Orion, Fulvestrant Ratiopharm, Fulvestrant Sandoz, Fulvestrant Stada
- France
- Fulvestrant
- Greece
- Fulvestrant Accord, Fulvestrant Demo, Fulvestrant Innovis
- Hungary
- Fulvestrant Aptapharma, Fulvestrant Elc, Fulvestrant Ever Pharma, Fulvestrant Pharmascience, Fulvestrant Sandoz, Fulvestrant Stada, Fulvestrant Teva, Fulvestrant Vipharm, Fulvesztrant Accord, Imarsa, Vastaloma
- Iceland
- Faslodex, Fulvestrant Accord, Fulvestrant Medical Valley, Fulvestrant Mylan, Fulvestrant Stada, Fulvestrant Teva, Vastaloma
- Ireland
- Fulvestrant Accord Healthcare Ireland, Fulvestrant Ever Pharma, Fulvestrant Reddy Holding, Fulvestrant Rowex, Fulvestrant Teva
- Italy
- Fulvestrant Accord, Fulvestrant Aurobindo, Fulvestrant Dr. Reddy's, Fulvestrant Ever Pharma, Fulvestrant Hikma, Fulvestrant Sandoz, Fulvestrant Zentiva
- Latvia
- Fulvestrant Aliud, Fulvestrant Stada
- Liechtenstein
- Faslodex, Fulvestrant Mylan
- Lithuania
- Fulvestrant Aliud, Fulvestrant Orion, Fulvestrant Sandoz, Fulvestrant Stada, Fulvestrant Teva, Fulvestrant Zentiva
- Luxembourg
- Fulvestrant Teva
- Malta
- Fulvestrant Eugia, Fulvestrant Ever Pharma
- Netherlands
- Fulvestrant, Imarsa, Vastaloma
- Norway
- Faslodex, Fulvestrant Accord, Fulvestrant Ever Pharma, Fulvestrant Medical Valley, Fulvestrant Mylan, Fulvestrant Reddy, Fulvestrant Stada
- Poland
- Fulvestrant Eugia, Fulvestrant Ever Pharma, Fulvestrant Medical Valley, Fulvestrant Reddy, Fulvestrant Sandoz, Fulvestrant Stada Stada, Fulvestrant Sun, Fulvestrant Vipharm, Fulwestrant Accord
- Portugal
- Ambiful, Cykostra, Fulvestrant Accord, Fulvestrant Adalvo, Fulvestrant Cttq, Fulvestrant Generis, Fulvestrant Hexal, Fulvestrant Hikma, Fulvestrant Orion, Fulvestrant Reddy, Fulvestrant Rompharm, Fulvestrant Sandoz
- Romania
- Falvax, Fulvestrant Accord, Fulvestrant Ever Pharma, Fulvestrant Rompharm, Fulvestrant Sun, Fulvestrant Teva, Imarsa
- Slovakia
- Fulvestrant Accord, Fulvestrant Ever Pharma, Fulvestrant Sandoz, Fulvestrant Stada, Fulvestrant Teva, Fulvestrant Vipharm
- Slovenia
- Fulvestrant Accord, Fulvestrant Aptapharma, Fulvestrant Ever Pharma, Fulvestrant Lek, Fulvestrant Teva
- Spain
- Afultrant, Ambiful, Cykostra, Fulvestrant Dr. Reddys, Fulvestrant Eugia, Fulvestrant Hikma, Fulvestrant Stada, Fulvestrant Stadafarma, Fulvestrant Sun, Fulvestrant Teva, Fulvestrant Viso Farmacéutica, Kileza, Onnimia, Strantas
- Sweden
- Fulvestrant Accord, Fulvestrant Ever Pharma, Fulvestrant Glenmark, Fulvestrant Medical Valley, Fulvestrant Orion, Fulvestrant Reddy, Fulvestrant Sandoz, Fulvestrant Stada, Fulvestrant Sun, Fulvestrant Teva
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Faslodex – EPAR, Product Information (OF THE TEXT <{MM/YYYY}> Detailed information on this medicin). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L02BA.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.