Umbipro: Opinion on medicine for use outside EU
chlorhexidine
Table of contents
Opinion on medicine for use outside the European Union
Withdrawn opinion
Overview
The opinion for Umbipro for use outside the European Union has been withdrawn at the request of the opinion holder.
Opinion details
| Product details | |
|---|---|
| Name of medicinal product |
Umbipro
|
| Agency 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Withdrawn opinion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 |
| Date of opinion |
28/04/2016
|
Product information
19/12/2019 Umbipro H-W-3799-IAIN-0005
Contents
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Pharmacotherapeutic group
-
Antiseptics and disinfectants
-
Biguanides and amidines
Therapeutic indication
Therapeutic indication
Umbipro is indicated for prophylaxis of omphalitis (infection of the umbilical cord) in newborn infants.
Assessment history
-
List item
Umbipro : Procedural steps taken and scientific information after opinion (PDF/652.89 KB)
First published: 31/07/2020
Last updated: 08/04/2022 -
List item
Umbipro : Public assessment report (PDF/1.15 MB)
Adopted
First published: 01/07/2016
Last updated: 08/04/2022
EMA/343450/2016 -
List item
CHMP summary of positive opinion for Umbipro (PDF/622.49 KB)
Adopted
First published: 29/04/2016
Last updated: 08/04/2022
EMA/CHMP/244784/2016