ProQuad
measles, mumps, rubella and varicella vaccine (live)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for ProQuad. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ProQuad.
Authorisation details
Product details | |
---|---|
Name |
ProQuad
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Agency product number |
EMEA/H/C/000622
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Active substance |
virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella
|
International non-proprietary name (INN) or common name |
measles, mumps, rubella and varicella vaccine (live)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07BD54
|
Publication details | |
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Marketing-authorisation holder |
MSD VACCINS
|
Revision |
24
|
Date of issue of marketing authorisation valid throughout the European Union |
05/04/2006
|
Contact address |
Product information
18/10/2018 ProQuad - EMEA/H/C/000622 - WS/1392
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- 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
Vaccines
Therapeutic indication
ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age.
ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.