Details

Product Name in the RMS: Pantoprazol Aurobindo 40 mg gastro-resistant tablets

MR Number: NL/H/2944/002
Date of outcome: 17.06.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Generic Chemical Substance Prescription Only
Active Substances	pantoprazole sesquihydrate 40 mg
Form	Gastro-resistant tablet
MA Holder in the RMS	Aurobindo Pharma BV Molenvliet 103 3335 LH Zwijndrecht The Netherlands
RMS	Netherlands
Date of last change	18.12.2020
ATC-Code	A02BC02 Pantoprazole

CMS Country	Domestic Product Name
Cyprus	PANTOPRAZOLE AUROBINDO GR TABS
Denmark
France
Germany	Pantoprazol Aurobindo 40 mg magensaftresistente Tablette
Italy
Malta	Pantoprazole Aurobindo 40 mg gastro-resistant tablets
Poland
Romania	Pantoprazol Aurobindo 40 mg comprimate gastrorezistente
Spain
Sweden
United Kingdom

Documents
PAR:	NL_H_2944_002_PAR.pdf (08.12.2014)
PARSummary:	NL_H_2944_002_PARSummary.pdf (08.12.2014)
FinalSPC:	NL_H_2944_002_FinalSPC.pdf (08.10.2020)
FinalPL:	NL_H_2944_002_FinalPL.pdf (08.10.2020)
FinalLabelling:	NL_H_2944_002_FinalLabelling_1of2.pdf (26.03.2019)
FinalLabelling:	NL_H_2944_002_FinalLabelling_2of2.pdf (26.03.2019)
Finalised Product Information:	NL_H_2944_002_FinalPI_1of6.pdf (09.07.2015)
Finalised Product Information:	NL_H_2944_002_FinalPI_2of6.pdf (09.07.2015)
Finalised Product Information:	NL_H_2944_002_FinalPI_3of6.pdf (09.07.2015)
Finalised Product Information:	NL_H_2944_002_FinalPI_4of6.pdf (09.07.2015)
Finalised Product Information:	NL_H_2944_002_FinalPI_5of6.pdf (09.07.2015)
Finalised Product Information:	NL_H_2944_002_FinalPI_6of6.pdf (09.07.2015)