LENALIDOMIDE MYLAN Hard capsule Ref.[28131] Active ingredients: Lenalidomide

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Mylan Ireland Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Product name and form

Lenalidomide Mylan 2.5 mg hard capsules.
Lenalidomide Mylan 5 mg hard capsules.
Lenalidomide Mylan 7.5 mg hard capsules.
Lenalidomide Mylan 10 mg hard capsules.
Lenalidomide Mylan 15 mg hard capsules.
Lenalidomide Mylan 20 mg hard capsules.
Lenalidomide Mylan 25 mg hard capsules.

Pharmaceutical Form

Hard capsule (capsule).

Lenalidomide Mylan 2.5 mg hard capsules: Green and white capsules, size 4, 14 mm, marked “MYLAN /LL 2.5”.

Lenalidomide Mylan 5 mg hard capsules: White capsules, size 2, 18 mm, marked “MYLAN/LL 5”.

Lenalidomide Mylan 7.5 mg hard capsules: Light grey and white capsules, size 2, 18 mm, marked “MYLAN/LL7.5”.

Lenalidomide Mylan 10 mg hard capsules: Green and light grey capsules, size 0, 22 mm, marked “MYLAN/LL 10”.

Lenalidomide Mylan 15 mg hard capsules: White capsules, size 0, 22 mm, marked “MYLAN/LL15”.

Lenalidomide Mylan 20 mg hard capsules: Green and white capsules, size 0, 22 mm, marked “MYLAN/LL 20”.

Lenalidomide Mylan 25 mg hard capsules: White capsules, size 0, 22 mm, marked “MYLAN/LL 25”.

Qualitative and quantitative composition

Lenalidomide Mylan 2.5 mg hard capsules: Each capsule contains 2.5 mg of lenalidomide.

Lenalidomide Mylan 5 mg hard capsules: Each capsule contains 5 mg of lenalidomide.

Lenalidomide Mylan 7.5 mg hard capsules: Each capsule contains 7.5 mg of lenalidomide.

Lenalidomide Mylan 10 mg hard capsules: Each capsule contains 10 mg of lenalidomide.

Lenalidomide Mylan 15 mg hard capsules: Each capsule contains 15 mg of lenalidomide.

Lenalidomide Mylan 20 mg hard capsules: Each capsule contains 20 mg of lenalidomide.

Lenalidomide Mylan 25 mg hard capsules: Each capsule contains 25 mg of lenalidomide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lenalidomide

The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties.

List of Excipients

Capsule contents:

Maize starch, pregelatinized
Cellulose, microcrystalline
Croscarmellose sodium
Silica, colloidal anhydrous
Sodium stearyl fumarate

Capsule shell:

Lenalidomide Mylan 2.5 mg hard capsules and Lenalidomide Mylan 20 mg hard capsules:

Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin
Indigo carmine (E132)

Lenalidomide Mylan 7.5 mg hard capsules:

Yellow iron oxide (E172)
Black iron oxide (E172)
Titanium dioxide (E171)
Gelatin

Lenalidomide Mylan 10 mg hard capsules:

Yellow iron oxide (E172)
Black iron oxide (E172)
Titanium dioxide (E172)
Indigo carmine (E132)
Gelatin

Lenalidomide Mylan 5 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules:

Titanium dioxide (E171)
Gelatin

Printing ink:

Shellac
Propylene glycol (E1520)

Lenalidomide Mylan 2.5 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules, Lenalidomide Mylan 7.5 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules:

Black iron oxide (E172)
Potassium hydroxide

Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 20 mg hard capsules:

Red iron oxide (E172)
Simeticone

Pack sizes and marketing

Lenalidomide Mylan 2.5 mg hard capsules, Lenalidomide Mylan 7.5 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Mylan 20 mg hard capsules, Lenalidomide Mylan 25 mg hard capsules:

  • PVC/PCTFE/Aluminium foil blister packs containing 7 hard capsules.

Lenalidomide Mylan 2.5 mg hard capsules, Lenalidomide Mylan 5 mg hard capsules, Lenalidomide Mylan 7.5 mg hard capsules, Lenalidomide Mylan 10 mg hard capsules, Lenalidomide Mylan 15 mg hard capsules, Lenalidomide Mylan 20 mg hard capsules Lenalidomide Mylan 25 mg hard capsules:

  • PVC/PCTFE/Aluminium foil perforated unit dose blister packs containing 7 × 1 hard capsules.
  • PVC/PCTFE/Aluminium foil blister packs containing 21 hard capsules.
  • PVC/PCTFE/Aluminium foil perforated unit dose blister packs containing 21 × 1 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Ireland Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization dates and numbers

EU/1/20/1490/001
EU/1/20/1490/002
EU/1/20/1490/003
EU/1/20/1490/004
EU/1/20/1490/005
EU/1/20/1490/006
EU/1/20/1490/007
EU/1/20/1490/008
EU/1/20/1490/009
EU/1/20/1490/010
EU/1/20/1490/011
EU/1/20/1490/012
EU/1/20/1490/013
EU/1/20/1490/014
EU/1/20/1490/015
EU/1/20/1490/016
EU/1/20/1490/017
EU/1/20/1490/018
EU/1/20/1490/019
EU/1/20/1490/020
EU/1/20/1490/021
EU/1/20/1490/022
EU/1/20/1490/023
EU/1/20/1490/024
EU/1/20/1490/025
EU/1/20/1490/026

Date of first authorisation: 18 December 2020

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