EMEA-001527-PIP01-13

Key facts

Active substance
(S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0183/2014
PIP number
EMEA-001527-PIP01-13
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Treatment of type 2 diabetes mellitus
Route(s) of administration
Oral use
Contact for public enquiries
Novartis Europharm Ltd
United Kingdom
Tel. +41 6132 41111
E-mail: paediatric.enquiries@novartis.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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