OVALEAP Solution for injection Ref.[8509] Active ingredients: Follitropin alfa

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Theramex Ireland Limited 3<sup>rd</sup> Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

Product name and form

Ovaleap 300 IU/0.5 mL solution for injection.

Ovaleap 450 IU/0.75 mL solution for injection.

Ovaleap 900 IU/1.5 mL solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless solution.

The pH of the solution is 6.8-7.2.

Qualitative and quantitative composition

Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa*.

Ovaleap 300 IU/0.5 mL solution for injection: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution for injection.

Ovaleap 450 IU/0.75 mL solution for injection: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution for injection.

Ovaleap 900 IU/1.5 mL solution for injection: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution for injection.

* Follitropin alfa (recombinant human follicle-stimulating hormone [r-hFSH]) is produced in Chinese Hamster Ovary Cells (CHO DHFR-) by recombinant DNA technology.

Excipient(s) with known effect:

Ovaleap contains 0.02 mg per mL of benzalkonium chloride.

Ovaleap contains 10.0 mg per mL of benzyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Follitropin alfa

In women, the most important effect resulting from parenteral administration of FSH is the development of mature Graafian follicles.

List of Excipients

Sodium dihydrogen phosphate dihydrate
Sodium hydroxide (2 M) (for pH adjustment)
Mannitol
Methionine
Polysorbate 20
Benzyl alcohol
Benzalkonium chloride
Water for injections

Pack sizes and marketing

Ovaleap 300 IU/0.5 mL solution for injection:

Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.5 mL of solution. Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½").

Pack size of 1 cartridge and 10 injection needles.

Not all pack sizes may be marketed.

Ovaleap 450 IU/0.75 mL solution for injection:

Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.75 mL of solution. Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½").

Pack size of 1 cartridge and 10 injection needles.

Not all pack sizes may be marketed.

Ovaleap 900 IU/1.5 mL solution for injection:

Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 1.5 mL of solution. Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½").

Pack size of 1 cartridge and 20 injection needles.

Not all pack sizes may be marketed

Marketing authorization holder

Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

Marketing authorization dates and numbers

Ovaleap 300 IU/0.5 mL solution for injection:

EU/1/13/871/001

Ovaleap 450 IU/0.75 mL solution for injection:

EU/1/13/871/002

Ovaleap 900 IU/1.5 mL solution for injection:

EU/1/13/871/003

Date of first authorisation: 27 September 2013
Date of latest renewal: 16 May 2018

Drugs

Drug Countries
OVALEAP Austria, Estonia, Spain, Finland, France, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom

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