EMEA-001764-PIP03-15

Key facts

Active substance
  • Tetracaine (hydrochloride)
  • oxymetazoline (hydrochloride)
Therapeutic area
Anaesthesiology
Decision number
P/0082/2016
PIP number
EMEA-001764-PIP03-15
Pharmaceutical form(s)
  • Nasal spray
  • solution
Condition(s) / indication(s)
Local anaesthesia
Route(s) of administration
Nasal use
Contact for public enquiries
St. Renatus, LLC
USA
Tel. +1 9704494455
Fax +1 9704494456
E-mail: ndiel@st-renatus.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-001764-PIP03-15
Compliance opinion date
21/04/2017
Compliance outcome
positive

Decision

How useful was this page?

Add your rating