P/198/2011

Key facts

Invented name
ellaOne
Active substance
ulipristal acetate
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/198/2011
PIP number
P/198/2011
Pharmaceutical form(s)
Tablet
Condition(s) / indication(s)
Contraception
Route(s) of administration
Oral use
Contact for public enquiries
Laboratoire HRA Pharma
regulatory@hra-pharma.com
France
Phone: +33 140331130
Fax: +33 142771060
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000305-PIP01-08-M02
Compliance opinion date
08/11/2013
Compliance outcome
positive

Decision

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