EMEA-001398-PIP02-13

Key facts

Active substance
  • Sodium benzylpenilloate
  • benzylpenicilloyl octa- L-lysine
Therapeutic area
Diagnostic
Decision number
P/0299/2013
PIP number
EMEA-001398-PIP02-13
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Diagnosis of beta-lactam allergy
Route(s) of administration
  • Skin scarification
  • Intradermal use
Contact for public enquiries
Diater Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.
Spain
E-mail: diater@diater.com 
Tel. +34 9149 660 13
Fax +34 9149 660 12
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-001398-PIP02-13
Compliance opinion date
12/09/2014
Compliance outcome
positive

Decision

How useful was this page?

Add your rating