Exparel liposomal
bupivacaine
Table of contents
Overview
Exparel liposomal is a local anaesthetic that is used in adults to treat pain after certain operations. It can be used either for local pain relief by injecting it around the edges of small to medium sized surgical wounds or for regional pain relief by injecting it around the nerves that supply the lower limbs or the shoulder. It contains the active substance bupivacaine.
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List item
Exparel liposomal : EPAR - Medicine overview (PDF/141.96 KB)
First published: 10/12/2020
EMA/503766/2020 -
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Exparel liposomal : EPAR - Risk-management-plan summary (PDF/151.05 KB)
First published: 10/12/2020
Authorisation details
Product details | |
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Name |
Exparel liposomal
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Agency product number |
EMEA/H/C/004586
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Active substance |
bupivacaine
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International non-proprietary name (INN) or common name |
bupivacaine
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Therapeutic area (MeSH) |
Acute Pain
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Anatomical therapeutic chemical (ATC) code |
N01BB01
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Publication details | |
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Marketing-authorisation holder |
Pacira Ireland Limited
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Date of issue of marketing authorisation valid throughout the European Union |
16/11/2020
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Contact address |
Product information
16/11/2020 Exparel liposomal - EMEA/H/C/004586 -
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
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Pharmacotherapeutic group
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Amides
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Anesthetics, local
Therapeutic indication
Exparel is indicated as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults.