Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300 Copenhagen S, Denmark
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen.
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen.
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection in a pre-filled pen (injection). Clear and colourless solution with a pH of 6.0-7.0. |
REKOVELLE 12 micrograms/0.36 mL solution for injection: One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution.
REKOVELLE 36 micrograms/1.08 mL solution for injection: One pre-filled multidose pen delivers 36 micrograms follitropin delta* in 1.08 mL solution.
REKOVELLE 72 micrograms/2.16 mL solution for injection: One pre-filled multidose pen delivers 72 micrograms follitropin delta* in 2.16 mL solution.
One mL of solution contains 33.3 micrograms of follitropin delta*.
* recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Follitropin delta |
Follitropin delta is a recombinant human FSH used for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART). Because follitropin delta is produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and follitropin beta. |
| List of Excipients |
|---|
|
Phenol |
REKOVELLE 12 micrograms/0.36 mL solution for injection: 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). Each cartridge contains 0.36 mL of solution. Pack size of 1 pre-filled pen and 3 injection needles (stainless steel).
REKOVELLE 36 micrograms/1.08 mL solution for injection: 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). Each cartridge contains 1.08 mL of solution. Pack size of 1 pre-filled pen and 6 injection needles (stainless steel).
REKOVELLE 72 micrograms/2.16 mL solution for injection: 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). Each cartridge contains 2.16 mL of solution. Pack size of 1 pre-filled pen and 9 injection needles (stainless steel).
Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300 Copenhagen S, Denmark
EU/1/16/1150/004
EU/1/16/1150/005
EU/1/16/1150/006
Date of first authorisation: 12 December 2016
| Drug | Countries | |
|---|---|---|
| REKOVELLE | Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom |
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