Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
Plegridy 63 micrograms solution for injection in pre-filled syringe.
Plegridy 94 micrograms solution for injection in pre-filled syringe.
Plegridy 125 micrograms solution for injection in pre-filled syringe.
Plegridy 63 micrograms solution for injection in pre-filled pen.
Plegridy 94 micrograms solution for injection in pre-filled pen.
Plegridy 125 micrograms solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear and colourless solution with pH 4.5-5.1. |
Plegridy 63 micrograms solution for injection in pre-filled syringe (for subcutaneous use): Each pre-filled syringe contains 63 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
Plegridy 94 micrograms solution for injection in pre-filled syringe (for subcutaneous use): Each pre-filled syringe contains 94 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
Plegridy 125 micrograms solution for injection in pre-filled syringe (for subcutaneous use): Each pre-filled syringe contains 125 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
Plegridy 125 micrograms solution for injection in pre-filled syringe (for intramuscular use): Each pre-filled syringe contains 125 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
Plegridy 63 micrograms solution for injection in pre-filled pen (for subcutaneous use): Each pre-filled pen contains 63 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
Plegridy 94 micrograms solution for injection in pre-filled pen (for subcutaneous use): Each pre-filled pen contains 94 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
Plegridy 125 micrograms solution for injection in pre-filled pen (for subcutaneous use): Each pre-filled pen contains 125 micrograms of peginterferon beta-1a* in 0.5 mL solution for injection.
The dose indicates the quantity of the interferon beta-1a moiety of peginterferon beta-1a without consideration of the PEG moiety attached.
* The active substance, peginterferon beta-1a, is a covalent conjugate of interferon beta-1a, produced in Chinese Hamster Ovary cells, with 20,000 Dalton (20 kDa) methoxy poly(ethyleneglycol) using an O-2-methylpropionaldehyde linker.
The potency of this medicinal product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class. For more information see section 5.1.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Peginterferon beta-1a |
Peginterferon beta-1a is an interferon conjugated to a single, linear 20 kDa methoxy poly(ethyleneglycol) molecule at the alpha-amino group of the N-terminal amino acid residue. A definitive mechanism of action of peginterferon beta-1a in multiple sclerosis (MS) is not known. Peginterferon beta-1a binds to the type I interferon receptor on the surface of cells and elicits a cascade of intracellular events leading to the regulation of interferon-responsive gene expression. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate |
1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 mL of solution. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.
A pre-filled syringe of Plegridy is contained within a single-use, disposable, spring-powered pen injector called Plegridy Pen. The syringe inside the pen is a 1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 mL of solution. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.
The Plegridy initiation pack contains 1x 63 micrograms pre-filled syringe (orange labelled syringe, 1st dose) and 1x 94 micrograms pre-filled syringe (blue labelled syringe, 2nd dose) in sealed plastic trays.
The Plegridy Pen initiation pack contains 1x 63 micrograms pre-filled pen (orange labelled pen, 1st dose) and 1x 94 micrograms pre-filled pen (blue labelled pen, 2nd dose) in a protective plastic tray.
Box of two or six 125 microgram pre-filled syringes (grey labelled syringes) in sealed plastic trays.
Box of two 125 microgram pre-filled pens (grey labelled pens) in a protective plastic tray.
Multipacks containing 6 (3 packs of 2) 125 microgram pre-filled pens (grey labelled pens). The pack contains 3 inner cartons. Each inner carton contains 2 pens in a protective plastic tray.
Not all pack sizes may be marketed.
Pre-filled syringe (intramuscular):
1 mL pre-filled Luer-Lok syringe made of glass (Type I) with a bromobutyl rubber stopper containing 0.5 mL of solution and supplied with a 23 gauge, 1.25 inch needle. A single pre-filled syringe contains 0.5 mL of solution of Plegridy containing 125 micrograms of peginterferon beta-1a.
Box of two or six 125 microgram pre-filled syringes in sealed plastic trays.
Not all pack sizes may be marketed.
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
EU/1/14/934/001
EU/1/14/934/002
EU/1/14/934/003
EU/1/14/934/004
EU/1/14/934/005
EU/1/14/934/006
EU/1/14/934/007
EU/1/14/934/008
Date of first authorisation: 18 July 2014
Date of latest renewal: 25 March 2019
| Drug | Countries | |
|---|---|---|
| PLEGRIDY | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, Turkey, United Kingdom, United States, South Africa |
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