LENZETTO Transdermal spray, solution Ref.[27664] Active ingredients: Estradiol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Product name and form

Lenzetto 1.53 mg/spray, transdermal spray, solution.

Pharmaceutical Form

Transdermal spray, solution.

The solution is clear, colourless to pale yellow.

Qualitative and quantitative composition

Each spray delivers 90 microliter of transdermal spray, solution containing 1.53 mg of estradiol (equivalent to 1.58 mg of estradiol hemihydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Estradiol

Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy.

List of Excipients

Octisalate
Ethanol 96%

Pack sizes and marketing

The solution is packaged in a glass vial fitted with a metered dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application of the metered dose spray.

One container is filled with 6,5 ml, transdermal spray solution and is designed to deliver 56 sprays after priming.

Pack sizes:

One plastic container 6,5 ml (56 sprays)

Three plastic containers 3x6,5 ml (3x56 sprays)

Not all pack sizes may be marketed.

Marketing authorization holder

Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Marketing authorization dates and numbers

PL 04854/0130

13/08/2015

Drugs

Drug Countries
LENZETTO Ecuador, Estonia, Spain, Finland, Croatia, Ireland, Lithuania, Malta, Netherlands, Poland, Romania, United Kingdom

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