BRAVELLE Powder and solvent for solution for injection Ref.[9733] Active ingredients: Urofollitropin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Product name and form

BRAVELLE 75 IU powder and solvent for solution for injection.

Pharmaceutical Form
Powder and solvent for solution for injection. Appearance of powder: Lyophilised, white to off-white caked mass. Appearance of solvent: Clear colourless solution.

Qualitative and quantitative composition

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.

Active Ingredient	Description
Urofollitropin	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.

List of Excipients
Powder: Lactose monohydrate Polysorbate 20 Sodium phosphate dibasic heptahydrate (for pH adjustment) Phosphoric acid (for pH adjustment) Water for injections Solvent: Sodium chloride Hydrochloric acid (for pH adjustment) Water for injections

Pack sizes and marketing

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:

5 vials of powder + 5 ampoules of solvent
10 vials of powder + 10 ampoules of solvent
5 vials of powder + 5 ampoules of solvent
5 syringes with needles for dissolution of the powder, 5 injection needles
5 disposable alcohol swabs
10 vials of powder + 10 ampoules of solvent
10 syringes with needles for dissolution of the powder, 10 injection needles
10 disposable alcohol swabs
30 vials of powder + 30 ampoules of solvent
15 syringes with needles for dissolution of the powder, 15 injection needles
15 disposable alcohol swabs

Not all pack sizes may be marketed.

Marketing authorization holder

Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Marketing authorization dates and numbers

PL 03194/0087

24^th March 2009

Drugs

Drug	Countries
BRAVELLE	Ecuador, Estonia, Lithuania, Poland, Singapore, South Africa

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