Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland
Myalepta 3 mg powder for solution for injection.
Myalepta 5.8 mg powder for solution for injection.
Myalepta 11.3 mg powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection (powder for injection). White lyophilised cake or powder. |
Myalepta 3 mg powder for solution for injection: Each vial contains 3 mg of metreleptin*.
After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Myalepta 5.8 mg powder for solution for injection: Each vial contains 5.8 mg of metreleptin*.
After reconstitution with 1.1 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Myalepta 11.3 mg powder for solution for injection: Each vial contains 11.3 mg of metreleptin*.
After reconstitution with 2.2 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
* Metreleptin is a recombinant human leptin analogue (produced in Escherichia coli cells by recombinant DNA technology to form recombinant methionyl-human leptin).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Metreleptin |
Metreleptin mimics the physiological effects of leptin by binding to and activating the human leptin receptor, which belongs to the Class I cytokine family of receptors that signals through the JAK/STAT transduction pathway. |
| List of Excipients |
|---|
|
Glycine |
Myalepta 3 mg powder for solution for injection: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/red plastic flip-off cap.
Myalepta 5.8 mg powder for solution for injection: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/blue plastic flip-off cap.
Myalepta 11.3 mg powder for solution for injection: Type I glass vial (5 mL) with a bromobutyl rubber stopper and an aluminium seal/white plastic flip-off cap.
Pack sizes of 1 or 30 vials.
Not all pack sizes may be marketed.
Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland
Myalepta 3 mg powder for solution for injection: EU/1/18/1276/003, EU/1/18/1276/004
Myalepta 5.8 mg powder for solution for injection: EU/1/18/1276/005, EU/1/18/1276/006
Myalepta 11.3 mg powder for solution for injection: EU/1/18/1276/001, EU/1/18/1276/002
Date of first authorisation: 30 July 2018
| Drug | Countries | |
|---|---|---|
| MYALEPTA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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