Details

Product Name in the RMS: Tacrolimus Lambda

MR Number: NL/H/1335/002
Date of outcome: 04.08.2010

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	tacrolimus 1 mg
Form	Capsule, hard
MA Holder in the RMS	Lambda Therapeutics Ltd/UK
RMS	Netherlands
Date of last change	18.05.2013
ATC-Code	L04AA Selective immunosuppressants

CMS Country	Domestic Product Name
Czech Republic	Tacrolimus Lambda 1 mg
Denmark	Tacrolimus "Lambda"
Finland
Poland
Slovak Republic	Tacrolimusum Lambda 1 mg kapsule
Spain

Documents
FinalSPC:	http://mri.medagencies.org/download/NL_H_1335_002_FinalSPC.pdf (08.11.2012)
FinalPL:	http://mri.medagencies.org/download/NL_H_1335_002_FinalPL.pdf (06.04.2012)
Finalised Product Information:	http://mri.medagencies.org/download/NL_H_1335_002_FinalPI.pdf (08.11.2012)