Key facts

Active Substance
Acotiamide
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0213/2013
PIP number
EMEA-001461-PIP01-13
Pharmaceutical form(s)
Coated tablet
Condition(s) / indication(s)
Treatment of functional dyspepsia
Route(s) of administration
Oral use
Contact for public enquiries

Zeria Pharmaceutical Co Ltd

tomoharu-miyagawa@zeria.co.jp
Tel. +44 (0)7528 697428

Decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Decision date

Decision

P/0213/2013: EMA decision of 3 September 2013 on the refusal of a product-specific waiver for acotiamide (EMEA-001461-PIP01-13)

How useful do you find this page?