Details

Product Name in the RMS: Lenalidomid Alvogen

MR Number: IS/H/0270/004
Date of outcome: 16.04.2018

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	lenalidomide 10 mg
Form	Capsule, hard
MA Holder in the RMS	Alvogen Malta Operations (ROW) Ltd., Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann SGN 3000, Malta
RMS	Iceland
Date of last change	02.02.2021
ATC-Code	L04AX04 Lenalidomide

CMS Country	Domestic Product Name
Bulgaria
Croatia	Lenalidomid Alvogen 10 mg tvrde kapsule
Latvia	Lenalidomide Alvogen 10 mg cietās kapsulas
Lithuania	Lenalidomide Alvogen 10 mg kietosios kapsulės
Romania
Slovak Republic	Lenalidomid Alvogen 10 mg tvrdé kapsuly
Slovenia

Documents
PAR:	IS_H_0270_004_PAR.pdf (04.07.2018)
FinalSPC:	IS_H_0270_004_FinalSPC.pdf (08.05.2020)
Finalised Product Information:	IS_H_0270_004_FinalPI.pdf (13.01.2021)