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Lidocaine/tetracaine - paediatric investigation plan
lidocaine
tetracaine
PIPHuman
Key facts
Active Substance
lidocaine
tetracaine
Therapeutic area
Anaesthesiology
Decision number
P/125/2010
PIP number
Lidocaine/tetracaine
Pharmaceutical form(s)
Cream
Condition(s) / indication(s)
Local anaesthesia
Route(s) of administration
Cutaneous use
Contact for public enquiries
ZARS Pharma
E-mail: PliaglisEU@zars.com Country: United States Phone: +1 8013500202 Fax: +1 8013500909
Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date
Decision
P/125/2010: European Medicines Agency decision of 28 July 2010 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for lidocaine/tetracaine (EMEA-000168-PIP...