Details

Product Name in the RMS: Brieka

MR Number: SE/H/1399/005
Date of outcome: 11.06.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	pregabalin 150 mg
Form	Capsule, hard
MA Holder in the RMS	Split procedure: New procedure no is IE/H/555/01-08 Actavis Group PTC ehf Iceland
RMS	Sweden
Date of last change	10.12.2018
ATC-Code	N03AX16 Pregabalin

CMS Country	Domestic Product Name
Austria	Brieka 150 mg Hartkapseln
Bulgaria	Erlicent
Denmark
Estonia	BRIEKA
Greece	ERLICENT
Hungary
Iceland	Brieka 150 mg hart hylki
Latvia	Brieka 150 mg cietās kapsulas
Lithuania	Brieka 150 mg kietosios kapsulės
Malta	Erlicent 150mg capsules, hard
Slovak Republic	Brieka 150 mg

Documents
PAR:	https://lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20140711000051 (23.10.2015)
PARSummary:	https://lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20140711000051 (23.10.2015)
FinalSPC:	https://lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20140711000051 (17.07.2015)
FinalPL:	https://lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20140711000051 (17.07.2015)