Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Faslodex 250 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to yellow, viscous solution. |
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Excipients with known effect (per 5 ml):
Ethanol (96%, 500 mg)
Benzyl alcohol (500 mg)
Benzyl benzoate (750 mg)
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fulvestrant |
Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol. Fulvestrant blocks the trophic actions of estrogens without any partial agonist (estrogen-like) activity. |
| List of Excipients |
|---|
|
Ethanol (96 per cent) |
The pre-filled syringe presentation consists of:
One clear type 1 glass pre-filled syringe with polystyrene plunger rod, fitted with a tamper-evident closure, containing 5 ml Faslodex solution for injection. A safety needle (BD SafetyGlide) for connection to the barrel is also provided.
Or
Two clear type 1 glass pre-filled syringes with polystyrene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Faslodex solution for injection. Safety needles (BD SafetyGlide) for connection to each barrel are also provided.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/03/269/001
EU/1/03/269/002
Date of first authorisation: 10 March 2004
Date of latest renewal: 10 March 2009
| Drug | Countries | |
|---|---|---|
| FASLODEX | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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