Details
Product Name in the RMS: Lansopram
MR Number: DK/H/2235/001
Date of outcome: 01.10.2013
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
lansoprazole 15 mg |
Form | Gastro-resistant capsule, hard |
MA Holder in the RMS |
Amneal Pharma Europe Limited 70 Sir John Rogerson´s Quay Dublin 2 Irland |
RMS | Denmark |
Date of last change | 21.12.2020 |
ATC-Code |
A02BC03 Lansoprazole |
CMS Country | Domestic Product Name |
---|---|
Czech Republic | Lansoprazol Momaja 15 mg, enterosolventní tobolka, tvrdá |
Ireland | |
Netherlands | |
Sweden |
Documents | |
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PAR: | DK_H_2235_001_PAR.pdf (22.02.2016) |
PARSummary: | DK_H_2235_001_PARSummary.pdf (22.02.2016) |
FinalSPC: | DK_H_2235_001_FinalSPC.pdf (29.01.2018) |
FinalPL: | DK_H_2235_001_FinalPL.pdf (11.01.2019) |
FinalLabelling: | DK_H_2235_001_FinalLabelling.pdf (11.01.2019) |