Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Elonva 100 micrograms solution for injection.
Elonva 150 micrograms solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear and colourless aqueous solution. |
Elonva 100 micrograms solution for injection: Each pre-filled syringe contains 100 micrograms of corifollitropin alfa* in 0.5 mL solution for injection.
Elonva 150 micrograms solution for injection: Each pre-filled syringe contains 150 micrograms of corifollitropin alfa* in 0.5 mL solution for injection.
* corifollitropin alfa is a glycoprotein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Excipient(s) with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Corifollitropin alfa |
Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (rec)FSH, but with a markedly prolonged duration of FSH activity. Corifollitropin alfa does not display any intrinsic LH/hCG activity. |
| List of Excipients |
|---|
|
Sodium citrate |
Elonva is supplied in pre-filled luerlock syringes of 1 mL (type I hydrolytic glass), closed with a bromobutyl elastomer plunger and a tip cap. The syringe is equipped with an automatic safety system to prevent needle stick injuries after use and is packed together with a sterile injection needle. Each pre-filled syringe contains 0.5 mL solution for injection.
Elonva is available in pack sizes of 1 pre-filled syringe.
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
EU/1/09/609/001
EU/1/09/609/002
Date of first authorisation: 25 January 2010
Date of latest renewal: 22 August 2014
| Drug | Countries | |
|---|---|---|
| ELONVA | Austria, Australia, Brazil, Cyprus, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey |
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