ARANESP Solution for injection in pre-filled syringe / pre-filled pen / vial Ref.[2701] Active ingredients: Darbepoetin alfa

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Product name and form

Aranesp 10 micrograms solution for injection in pre-filled syringe.
Aranesp 15 micrograms solution for injection in pre-filled syringe.
Aranesp 20 micrograms solution for injection in pre-filled syringe.
Aranesp 30 micrograms solution for injection in pre-filled syringe.
Aranesp 40 micrograms solution for injection in pre-filled syringe.
Aranesp 50 micrograms solution for injection in pre-filled syringe.
Aranesp 60 micrograms solution for injection in pre-filled syringe.
Aranesp 80 micrograms solution for injection in pre-filled syringe.
Aranesp 100 micrograms solution for injection in pre-filled syringe.
Aranesp 130 micrograms solution for injection in pre-filled syringe.
Aranesp 150 micrograms solution for injection in pre-filled syringe.
Aranesp 300 micrograms solution for injection in pre-filled syringe.
Aranesp 500 micrograms solution for injection in pre-filled syringe.

Aranesp 10 micrograms solution for injection in pre-filled pen.
Aranesp 15 micrograms solution for injection in pre-filled pen.
Aranesp 20 micrograms solution for injection in pre-filled pen.
Aranesp 30 micrograms solution for injection in pre-filled pen.
Aranesp 40 micrograms solution for injection in pre-filled pen.
Aranesp 50 micrograms solution for injection in pre-filled pen.
Aranesp 60 micrograms solution for injection in pre-filled pen.
Aranesp 80 micrograms solution for injection in pre-filled pen.
Aranesp 100 micrograms solution for injection in pre-filled pen.
Aranesp 130 micrograms solution for injection in pre-filled pen.
Aranesp 150 micrograms solution for injection in pre-filled pen.
Aranesp 300 micrograms solution for injection in pre-filled pen.
Aranesp 500 micrograms solution for injection in pre-filled pen.

Aranesp 25 micrograms solution for injection in vial.
Aranesp 40 micrograms solution for injection in vial.
Aranesp 60 micrograms solution for injection in vial.
Aranesp 100 micrograms solution for injection in vial.
Aranesp 200 micrograms solution for injection in vial.
Aranesp 300 micrograms solution for injection in vial.

Pharmaceutical Form

Solution for injection (injection) in pre-filled syringe.

Solution for injection (injection) in pre-filled pen (SureClick).

Solution for injection (injection) in vial.

Clear, colourless solution.

Qualitative and quantitative composition

Ara*nesp 10 micrograms solution for injection in pre-filled syringe:

  • ach pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL).

Aranesp 15 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL).
Aranesp 20 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL).
Aranesp 30 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL).
Aranesp 40 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL).
Aranesp 50 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL).
Aranesp 60 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL).
Aranesp 80 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL).
Aranesp 100 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL).
Aranesp 130 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL).
Aranesp 150 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL).
Aranesp 300 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL).
Aranesp 500 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL).

Aranesp 10 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL).
Aranesp 15 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 15 micrograms of darbepoetin alfa in 0.375 mL (40 mcg/mL).
Aranesp 20 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 20 micrograms of darbepoetin alfa in 0.5 mL (40 mcg/mL).
Aranesp 30 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 30 micrograms of darbepoetin alfa in 0.3 mL (100 mcg/mL).
Aranesp 40 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 40 micrograms of darbepoetin alfa in 0.4 mL (100 mcg/mL).
Aranesp 50 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 50 micrograms of darbepoetin alfa in 0.5 mL (100 mcg/mL).
Aranesp 60 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 60 micrograms of darbepoetin alfa in 0.3 mL (200 mcg/mL).
Aranesp 80 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 80 micrograms of darbepoetin alfa in 0.4 mL (200 mcg/mL).
Aranesp 100 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 100 micrograms of darbepoetin alfa in 0.5 mL (200 mcg/mL).
Aranesp 130 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 130 micrograms of darbepoetin alfa in 0.65 mL (200 mcg/mL).
Aranesp 150 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 150 micrograms of darbepoetin alfa in 0.3 mL (500 mcg/mL).
Aranesp 300 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 300 micrograms of darbepoetin alfa in 0.6 mL (500 mcg/mL).
Aranesp 500 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 500 micrograms of darbepoetin alfa in 1 mL (500 mcg/mL).

Aranesp 25 micrograms solution for injection in vial: Each vial contains 25 micrograms of darbepoetin alfa in 1 mL (25 mcg/mL).
Aranesp 40 micrograms solution for injection in vial: Each vial contains 40 micrograms of darbepoetin alfa in 1 mL (40 mcg/mL).
Aranesp 60 micrograms solution for injection in vial: Each vial contains 60 micrograms of darbepoetin alfa in 1 mL (60 mcg/mL).
Aranesp 100 micrograms solution for injection in vial: Each vial contains 100 micrograms of darbepoetin alfa in 1 mL (100 mcg/mL).
Aranesp 200 micrograms solution for injection in vial: Each vial contains 200 micrograms of darbepoetin alfa in 1 mL (200 mcg/mL).
Aranesp 300 micrograms solution for injection in vial: Each vial contains 300 micrograms of darbepoetin alfa in 1 mL (300 mcg/mL).

Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

Excipient with known effect:

Aranesp 10 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL.
Aranesp 15 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.42 mg of sodium in 0.375 mL.
Aranesp 20 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL.
Aranesp 30 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL.
Aranesp 40 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL.
Aranesp 50 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL.
Aranesp 60 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL.
Aranesp 80 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.52 mg of sodium in 0.4 mL.
Aranesp 100 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.90 mg of sodium in 0.5 mL.
Aranesp 130 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 2.46 mg of sodium in 0.65 mL.
Aranesp 150 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 1.14 mg of sodium in 0.3 mL.
Aranesp 300 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 2.27 mg of sodium in 0.6 mL.
Aranesp 500 micrograms solution for injection in pre-filled syringe: Each pre-filled syringe contains 3.79 mg of sodium in 1 mL.

Aranesp 10 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.52 mg of sodium in 0.4 mL.
Aranesp 15 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.42 mg of sodium in 0.375 mL.
Aranesp 20 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.90 mg of sodium in 0.5 mL.
Aranesp 30 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL.
Aranesp 40 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.52 mg of sodium in 0.4 mL.
Aranesp 50 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.90 mg of sodium in 0.5 mL.
Aranesp 60 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL.
Aranesp 80 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.52 mg of sodium in 0.4 mL.
Aranesp 100 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.90 mg of sodium in 0.5 mL.
Aranesp 130 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 2.46 mg of sodium in 0.65 mL.
Aranesp 150 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 1.14 mg of sodium in 0.3 mL.
Aranesp 300 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 2.27 mg of sodium in 0.6 mL.
Aranesp 500 micrograms solution for injection in pre-filled pen: Each pre-filled pen contains 3.79 mg of sodium in 1 mL.

Aranesp 25 micrograms solution for injection in vial: Each vial contains 3.79 mg of sodium.
Aranesp 40 micrograms solution for injection in vial: Each vial contains 3.79 mg of sodium.
Aranesp 60 micrograms solution for injection in vial: Each vial contains 3.79 mg of sodium.
Aranesp 100 micrograms solution for injection in vial: Each vial contains 3.79 mg of sodium.
Aranesp 200 micrograms solution for injection in vial: Each vial contains 3.79 mg of sodium.
Aranesp 300 micrograms solution for injection in vial: Each vial contains 3.79 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Darbepoetin alfa

Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone. Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three. The additional sugar residues are molecularly indistinct from those on the endogenous hormone. Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater in vivo activity.

List of Excipients

Sodium phosphate monobasic
Sodium phosphate dibasic
Sodium chloride
Polysorbate 80
Water for injections

Pack sizes and marketing

Aranesp 10 micrograms solution for injection in pre-filled syringe: 0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 15 micrograms solution for injection in pre-filled syringe: 0.375 mL solution for injection (40 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 20 micrograms solution for injection in pre-filled syringe: 0.5 mL solution for injection (40 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 30 micrograms solution for injection in pre-filled syringe: 0.3 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 40 micrograms solution for injection in pre-filled syringe: 0.4 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 50 micrograms solution for injection in pre-filled syringe: 0.5 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 60 micrograms solution for injection in pre-filled syringe: 0.3 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 80 micrograms solution for injection in pre-filled syringe: 0.4 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 100 micrograms solution for injection in pre-filled syringe: 0.5 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 130 micrograms solution for injection in pre-filled syringe: 0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 150 micrograms solution for injection in pre-filled syringe: 0.3 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 300 micrograms solution for injection in pre-filled syringe: 0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

Aranesp 500 micrograms solution for injection in pre-filled syringe: 1 mL solution for injection (500 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled syringes.

The syringes may be presented in either blistered (1- and 4-pack), with or without an automatic needle guard or non-blistered packaging (1-pack only).

The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex). See section 4.4.

Aranesp 10 micrograms solution for injection in pre-filled pen: 0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 15 micrograms solution for injection in pre-filled pen: 0.375 mL solution for injection (40 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 20 micrograms solution for injection in pre-filled pen: 0.5 mL solution for injection (40 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 30 micrograms solution for injection in pre-filled pen: 0.3 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 40 micrograms solution for injection in pre-filled pen: 0.4 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 50 micrograms solution for injection in pre-filled pen: 0.5 mL solution for injection (100 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 60 micrograms solution for injection in pre-filled pen: 0.3 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 80 micrograms solution for injection in pre-filled pen: 0.4 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 100 micrograms solution for injection in pre-filled pen: 0.5 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 130 micrograms solution for injection in pre-filled pen: 0.65 mL solution for injection (200 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 150 micrograms solution for injection in pre-filled pen: 0.3 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 300 micrograms solution for injection in pre-filled pen: 0.6 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

Aranesp 500 micrograms solution for injection in pre-filled pen: 1 mL solution for injection (500 mcg/mL darbepoetin alfa) in a pre-filled pen with type 1 glass syringe and stainless steel 27 gauge needle. Pack size of 1 or 4 pre-filled pens.

The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex). See section 4.4.

Aranesp 25 micrograms solution for injection in vial: 1 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials.

Aranesp 40 micrograms solution for injection in vial: 1 mL solution for injection (40 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials.

Aranesp 60 micrograms solution for injection in vial: 1 mL solution for injection (60 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials.

Aranesp 100 micrograms solution for injection in vial: 1 mL solution for injection (100 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials.

Aranesp 200 micrograms solution for injection in vial: 1 mL solution for injection (200 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials.

Aranesp 300 micrograms solution for injection in vial: 1 mL solution for injection (300 mcg/mL darbepoetin alfa) in a type 1 glass vial with fluoropolymer laminated elastomeric stopper and an aluminium seal with flip-off dust cover. Pack size of 1 or 4 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Marketing authorization dates and numbers

Aranesp 10 micrograms solution for injection pre-filled syringe:

EU/1/01/185/001 1 Pack Blister
EU/1/01/185/002 4 Pack Blister
EU/1/01/185/033 1 Pack Unblistered
EU/1/01/185/074 1 blister pack with needle guard
EU/1/01/185/075 4 blister pack with needle guard

Aranesp 15 micrograms solution for injection pre-filled syringe:

EU/1/01/185/003 1 Pack Blister
EU/1/01/185/004 4 Pack Blister
EU/1/01/185/034 1 Pack Unblistered
EU/1/01/185/076 1 blister pack with needle guard
EU/1/01/185/077 4 blister pack with needle guard

Aranesp 20 micrograms solution for injection pre-filled syringe:

EU/1/01/185/005 1 Pack Blister
EU/1/01/185/006 4 Pack Blister
EU/1/01/185/035 1 Pack Unblistered
EU/1/01/185/078 1 blister pack with needle guard
EU/1/01/185/079 4 blister pack with needle guard

Aranesp 30 micrograms solution for injection pre-filled syringe:

EU/1/01/185/007 1 Pack Blister
EU/1/01/185/008 4 Pack Blister
EU/1/01/185/036 1 Pack Unblistered
EU/1/01/185/080 1 blister pack with needle guard
EU/1/01/185/081 4 blister pack with needle guard

Aranesp 40 micrograms solution for injection pre-filled syringe:

EU/1/01/185/009 1 Pack Blister
EU/1/01/185/010 4 Pack Blister
EU/1/01/185/037 1 Pack Unblistered
EU/1/01/185/082 1 blister pack with needle guard
EU/1/01/185/083 4 blister pack with needle guard

Aranesp 50 micrograms solution for injection pre-filled syringe:

EU/1/01/185/011 1 Pack Blister
EU/1/01/185/012 4 Pack Blister
EU/1/01/185/038 1 Pack Unblistered
EU/1/01/185/084 1 blister pack with needle guard
EU/1/01/185/085 4 blister pack with needle guard

Aranesp 60 micrograms solution for injection pre-filled syringe:

EU/1/01/185/013 1 Pack Blister
EU/1/01/185/014 4 Pack Blister
EU/1/01/185/039 1 Pack Unblistered
EU/1/01/185/086 1 blister pack with needle guard
EU/1/01/185/087 4 blister pack with needle guard

Aranesp 80 micrograms solution for injection pre-filled syringe:

EU/1/01/185/015 1 Pack Blister
EU/1/01/185/016 4 Pack Blister
EU/1/01/185/040 1 Pack Unblistered
EU/1/01/185/088 1 blister pack with needle guard
EU/1/01/185/089 4 blister pack with needle guard

Aranesp 100 micrograms solution for injection pre-filled syringe:

EU/1/01/185/017 1 Pack Blister
EU/1/01/185/018 4 Pack Blister
EU/1/01/185/041 1 Pack Unblistered
EU/1/01/185/090 1 blister pack with needle guard
EU/1/01/185/091 4 blister pack with needle guard

Aranesp 130 micrograms solution for injection pre-filled syringe:

EU/1/01/185/069 1 Pack Blister
EU/1/01/185/070 4 Pack Blister
EU/1/01/185/071 1 Pack Unblistered
EU/1/01/185/092 1 blister pack with needle guard
EU/1/01/185/093 4 blister pack with needle guard

Aranesp 150 micrograms solution for injection pre-filled syringe:

EU/1/01/185/019 1 Pack Blister
EU/1/01/185/020 4 Pack Blister
EU/1/01/185/042 1 Pack Unblistered
EU/1/01/185/094 1 blister pack with needle guard
EU/1/01/185/095 4 blister pack with needle guard

Aranesp 300 micrograms solution for injection pre-filled syringe:

EU/1/01/185/021 1 Pack Blister
EU/1/01/185/022 4 Pack Blister
EU/1/01/185/043 1 Pack Unblistered
EU/1/01/185/096 1 blister pack with needle guard
EU/1/01/185/097 4 blister pack with needle guard

Aranesp 500 micrograms solution for injection pre-filled syringe:

EU/1/01/185/031 1 Pack Blister
EU/1/01/185/032 4 Pack Blister
EU/1/01/185/044 1 Pack Unblistered
EU/1/01/185/098 1 blister pack with needle guard
EU/1/01/185/099 4 blister pack with needle guard

Aranesp 10 micrograms solution for injection pre-filled pen:

EU/1/01/185/045-1 pack
EU/1/01/185/057-4 pack

Aranesp 15 micrograms solution for injection pre-filled pen:

EU/1/01/185/046-1 pack
EU/1/01/185/058-4 pack

Aranesp 20 micrograms solution for injection pre-filled pen:

EU/1/01/185/047-1 pack
EU/1/01/185/059-4 pack

Aranesp 30 micrograms solution for injection pre-filled pen:

EU/1/01/185/048-1 pack
EU/1/01/185/060-4 pack
Aranesp 40 micrograms solution for injection pre-filled pen:
EU/1/01/185/049-1 pack
EU/1/01/185/061-4 pack

Aranesp 50 micrograms solution for injection pre-filled pen:

EU/1/01/185/050-1 pack
EU/1/01/185/062-4 pack

Aranesp 60 micrograms solution for injection pre-filled pen:

EU/1/01/185/051-1 pack
EU/1/01/185/063-4 pack

Aranesp 80 micrograms solution for injection pre-filled pen:

EU/1/01/185/052-1 pack
EU/1/01/185/064-4 pack

Aranesp 100 micrograms solution for injection pre-filled pen:

EU/1/01/185/053-1 pack
EU/1/01/185/065-4 pack

Aranesp 130 micrograms solution for injection pre-filled pen:

EU/1/01/185/072-1 pack
EU/1/01/185/073-4 pack

Aranesp 150 micrograms solution for injection pre-filled pen:

EU/1/01/185/054-1 pack
EU/1/01/185/066-4 pack

Aranesp 300 micrograms solution for injection pre-filled pen:

EU/1/01/185/055-1 pack
EU/1/01/185/067-4 pack

Aranesp 500 micrograms solution for injection pre-filled pen:

EU/1/01/185/056-1 pack
EU/1/01/185/068-4 pack

Aranesp 25 micrograms solution for injection vial:

EU/1/01/185/100 1 Pack
EU/1/01/185/101 4 Pack

Aranesp 40 micrograms solution for injection vial:

EU/1/01/185/102 1 Pack
EU/1/01/185/103 4 Pack

Aranesp 60 micrograms solution for injection vial:

EU/1/01/185/104 1 Pack
EU/1/01/185/105 4 Pack

Aranesp 100 micrograms solution for injection vial:

EU/1/01/185/106 1 Pack
EU/1/01/185/107 4 Pack

Aranesp 200 micrograms solution for injection vial:

EU/1/01/185/108 1 Pack
EU/1/01/185/109 4 Pack

Aranesp 300 micrograms solution for injection vial:

EU/1/01/185/110 1 Pack
EU/1/01/185/111 4 Pack

Date of first authorisation: 8 June 2001
Date of latest renewal: 19 May 2006

Drugs

Drug Countries
ARANESP Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom, United States, South Africa

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