Umbipro - opinion on medicine for use outside EU

chlorhexidine

Overview

The opinion for Umbipro for use outside the European Union has been withdrawn at the request of the opinion holder.

Umbipro : Medicine overview

Reference Number: EMA/311601/2016

Product information

Umbipro : Product information

Latest procedure affecting product information: H-W-3799-IAIN-0005

19/12/2019

Product information documents contain:

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturer responsible for batch release
• Annex IIB - Recommendations to the opinion holder - conditions of use
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Umbipro : All presentations

Pharmacotherapeutic group

• Antiseptics and disinfectants
• Biguanides and amidines

Therapeutic indication

Umbipro is indicated for prophylaxis of omphalitis (infection of the umbilical cord) in newborn infants.

Opinion details

Product details

• Name of medicine:
  Umbipro
• EMA opinion number:
  H-W-3799
• Opinion status:
  Withdrawn opinion
• Active substance:
  chlorhexidine digluconate
• International non-proprietary name (INN) or common name:
  chlorhexidine
• Therapeutic area (MeSH):
  Soft Tissue Infections
• Anatomical therapeutic chemical (ATC) code:
  D08AC02

Publication details

• Opinion holder:
  GlaxoSmithKline Trading Services

  12 Riverwalk; Citywest Business Campus; Dublin 24; Ireland

• Date of opinion:
  28/04/2016

Assessment history

Umbipro : Procedural steps taken and scientific information after opinion

CHMP summary of positive opinion for Umbipro

AdoptedReference Number: EMA/CHMP/244784/2016

Umbipro : Public assessment report

AdoptedReference Number: EMA/343450/2016