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
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. |
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 |
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
Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
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
| Drug | Countries | |
|---|---|---|
| OVALEAP | Austria, Estonia, Spain, Finland, France, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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