Source: Medicines & Healthcare Products Regulatory Agency (GB) | Revision Year: 2016 | Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
BRAVELLE 75 IU powder and solvent for solution for injection.
Powder and solvent for solution for injection.
Appearance of powder: Lyophilised, white to off-white caked mass.
Appearance of solvent: Clear colourless solution.
Each vial of powder contains 82.5 IU of highly purified urinary follicle stimulating hormone (FSH), urofollitropin. When reconstituted with the solvent provided, each vial delivers 75 IU of FSH.
For the full list of excipients, see section 6.1.
Urofollitropin contains a highly purified preparation of urinary FSH extracted from the urine of postmenopausal women. FSH stimulates ovarian follicular growth and development as well as gonadal steroid production in women who do not have primary ovarian failure.
Sodium phosphate dibasic heptahydrate (for pH adjustment)
Phosphoric acid (for pH adjustment)
Water for injections
Hydrochloric acid (for pH adjustment)
Water for injections
Powder: The powder for solution for injection is supplied in a 2 mL single dose colourless type I glass vial with a bromobutyl
rubber stopper closed with an aluminium/polypropen cap.
Solvent: The solvent for solution for injection is provided in a 1 mL single dose colourless type I glass ampoule.
BRAVELLE is supplied in the following pack sizes:
Not all pack sizes may be marketed.
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
24th March 2009
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