EMEA-002514-PIP01-18

Table of contents

Key facts

Active substance
  • Mometasone (furoate monohydrate)
  • Olopatadine (hydrochloride) (GSP 301 NS)
Therapeutic area
Oto-rhino-laryngology
Decision number
P/0170/2019
PIP number
EMEA-002514-PIP01-18
Pharmaceutical form(s)
Nasal spray, suspension
Condition(s) / indication(s)
Treatment of allergic rhinitis / rhino-conjunctivitis
Route(s) of administration
Intranasal use
Contact for public enquiries
Glenmark Pharmaceuticals Europe Ltd

Tel.: +44 1923202950
E-mail: PIP@glenmarkpharma.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-002514-PIP01-18
Compliance opinion date
27/03/2020
Compliance outcome
positive

Decision

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