Details

Product Name in the RMS: Preglenix

MR Number: CZ/H/0741/003
Date of outcome: 23.06.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	pregabalin 300 mg
Form	Capsule, hard
MA Holder in the RMS	Glenmark Pharmaceuticals s.r.o.
RMS	Czech Republic
Date of last change	21.08.2020
ATC-Code	N03AX16 Pregabalin

CMS Country	Domestic Product Name
Slovak Republic	Preglenix 300 mg tvrdé kapsuly

Documents
PAR:	CZ_H_0741_003_PAR.pdf (09.11.2015)
FinalSPC:	CZ_H_0741_003_FinalSPC.pdf (14.08.2020)
FinalPL:	CZ_H_0741_003_FinalPL.pdf (14.08.2020)
FinalLabelling:	CZ_H_0741_003_FinalLabelling.pdf (20.07.2018)
Finalised Product Information:	CZ_H_0741_003_FinalPI_1of3.pdf (24.06.2015)
Finalised Product Information:	CZ_H_0741_003_FinalPI_2of3.pdf (24.06.2015)
Finalised Product Information:	CZ_H_0741_003_FinalPI_3of3.pdf (24.06.2015)