Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, The Netherlands
Puregon 50 IU/0.5 mL solution for injection.
Puregon 75 IU/0.5 mL solution for injection.
Puregon 100 IU/0.5 mL solution for injection.
Puregon 150 IU/0.5 mL solution for injection.
Puregon 200 IU/0.5 mL solution for injection.
Puregon 225 IU/0.5 mL solution for injection.
| Pharmaceutical Form |
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Solution for injection (injection). Clear and colourless solution. |
Puregon 50 IU/0.5 mL solution for injection: One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 100 IU/mL. One vial contains 5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH/mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Puregon 75 IU/0.5 mL solution for injection: One vial contains 75 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 150 IU/mL. One vial contains 7.5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH/mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Puregon 100 IU/0.5 mL solution for injection: One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 200 IU/mL. One vial contains 10 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH/mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Puregon 150 IU/0.5 mL solution for injection: One vial contains 150 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 300 IU/mL. One vial contains 15 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH/mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Puregon 200 IU/0.5 mL solution for injection: One vial contains 200 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 400 IU/mL. One vial contains 20 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH/mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
Puregon 225 IU/0.5 mL solution for injection: One vial contains 225 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution. This corresponds to a strength of 450 IU/mL. One vial contains 22.5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH/mg protein). The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Follitropin beta |
Follitropin beta is a recombinant FSH. Follitropin beta can be used to stimulate follicular development and steroid production in selected cases of disturbed gonadal function. Furthermore follitropin beta can be used to promote multiple follicular development in medically assisted reproduction programs. |
| List of Excipients |
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Puregon solution for injection contains: Sucrose The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. |
0.5 mL of solution in 3 mL vial (type I glass) with stopper (chlorobutyl rubber).
Pack of 1, 5 or 10 vials.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN, Haarlem, The Netherlands
Puregon 50 IU/0.5 mL solution for injection:
EU/1/96/008/017
EU/1/96/008/018
EU/1/96/008/019
Puregon 75 IU/0.5 mL solution for injection:
EU/1/96/008/020
EU/1/96/008/021
EU/1/96/008/022
Puregon 100 IU/0.5 mL solution for injection:
EU/1/96/008/023
EU/1/96/008/024
EU/1/96/008/025
Puregon 150 IU/0.5 mL solution for injection:
EU/1/96/008/026
EU/1/96/008/027
EU/1/96/008/028
Puregon 200 IU/0.5 mL solution for injection:
EU/1/96/008/029
EU/1/96/008/030
EU/1/96/008/031
Puregon 225 IU/0.5 mL solution for injection:
EU/1/96/008/032
EU/1/96/008/033
EU/1/96/008/034
Date of first authorisation: 03 May 1996
Date of latest renewal: 29 May 2006
| Drug | Countries | |
|---|---|---|
| PUREGON | Austria, Australia, Canada, Cyprus, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, South Africa |
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