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

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.

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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