Details

Product Name in the RMS: TADOGLEN 50/37.5/200 mg

MR Number: CZ/H/0743/003
Date of outcome: 17.01.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	carbidopa monohydrate 37,5 mg entacapone 200 mg levodopa 150 mg
Form	Film coated tablet
MA Holder in the RMS	Change RMS FI/H/831 Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b 14074 Praha 4 Czech Republic
RMS	Czech Republic
Date of last change	17.08.2021
ATC-Code	N04BA03 Levodopa, decarboxylase inhibitor and COMT inhibitor

CMS Country	Domestic Product Name
Romania	Tadoglen 150 mg/37,5 mg/200 mg comprimate filmate
Slovak Republic

Documents
FinalSPC:	CZ_H_0743_003_FinalSPC.pdf (28.11.2019)
FinalPL:	CZ_H_0743_003_FinalPL.pdf (28.11.2019)
FinalLabelling:	CZ_H_0743_003_FinalLabelling.pdf (26.02.2021)
Finalised Product Information:	CZ_H_0743_003_FinalPI.pdf (06.06.2018)