Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Pegasys 90 micrograms solution for injection in pre-filled syringe.
Pegasys 135 micrograms solution for injection in pre-filled syringe.
Pegasys 180 micrograms solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). The solution is clear and colourless to light yellow. |
Pegasys 90 micrograms solution for injection in pre-filled syringe: Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a*.
Pegasys 135 micrograms solution for injection in pre-filled syringe: Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a*.
Pegasys 180 micrograms solution for injection in pre-filled syringe: Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*.
The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation.
* The active substance, peginterferon alfa-2a, is a covalent conjugate of the protein interferon alfa-2a produced by recombinant DNA technology in Escherichia coli with bis-[monomethoxy polyethylene glycol].
The potency of this medicinal product should not be compared to the one of another pegylated or nonpegylated protein of the same therapeutic class. For more information, see section 5.1.
Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Peginterferon alpha-2a |
Peginterferon alpha-2a is a pegylated interferon alfa-2a that possesses the in vitro antiviral and antiproliferative activities that are characteristic of interferon alfa-2a. Peginterferon alpha-2a is indicated for the treatment of hepatitis B and C. |
| List of Excipients |
|---|
|
Sodium chloride |
0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a plunger stopper and tip cap (butyl rubber laminated on the product facing side with fluororesin) with a needle.
Pegasys 90 micrograms solution for injection in pre-filled syringe: The syringe is labeled with graduations corresponding to doses of 90 mcg, 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg. Available in packs of 1 pre-filled syringe.
Pegasys 135 micrograms solution for injection in pre-filled syringe: The syringe is labeled with graduations corresponding to doses of 135 mcg, 90 mcg and 45 mcg. Available in packs of 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes. Not all pack-sizes may be marketed.
Pegasys 180 micrograms solution for injection in pre-filled syringe: The syringe is labeled with graduations corresponding to doses of 180 mcg, 135 mcg and 90 mcg. Available in packs of 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes. Not all pack-sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Pegasys 90 micrograms solution for injection in pre-filled syringe:
EU/1/02/221/017
Pegasys 135 micrograms solution for injection in pre-filled syringe:
EU/1/02/221/005
EU/1/02/221/006
EU/1/02/221/009
Pegasys 180 micrograms solution for injection in pre-filled syringe:
EU/1/02/221/007
EU/1/02/221/008
EU/1/02/221/010
Date of first authorisation: 20 June 2002
Date of latest renewal: 20 June 2007
| Drug | Countries | |
|---|---|---|
| PEGASYS | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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