REKOVELLE Solution for injection Ref.[9738] Active ingredients: Follitropin delta

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300 Copenhagen S, Denmark

Product name and form

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.

Qualitative and quantitative composition

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
Polysorbate 20
L-methionine
Sodium sulphate decahydrate
Disodium phosphate dodecahydrate
Phosphoric acid, concentrated (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)
Water for injections

Pack sizes and marketing

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).

Marketing authorization holder

Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300 Copenhagen S, Denmark

Marketing authorization dates and numbers

EU/1/16/1150/004
EU/1/16/1150/005
EU/1/16/1150/006

Date of first authorisation: 12 December 2016

Drugs

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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