Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK): Opinion on medicine for use outside EU
lamivudine / zidovudine
Table of contents
Overview
The opinion for Lamivudine / Zidovudine ViiV for use outside the European Union has been withdrawn at the request of the opinion holder.
Opinion details
| Product details | |
|---|---|
| Name of medicinal product |
Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK)
|
| Agency opinion number |
H/W/672
|
| Opinion status |
Withdrawn opinion
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
HIV Infections
|
| Anatomical therapeutic chemical (ATC) code |
J05AR01
|
| Publication details | |
|---|---|
| Opinion holder |
ViiV Healtcare UK Limited |
| Date of opinion |
17/11/2005
|
Product information
17/09/2015 Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK) H-W-672-WS-0755
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
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Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
Lamivudine/zidovudine is indicated as part of antiretroviral combination therapy for the treatment of human immunodeficiency virus (HIV) infected adults and children.
Assessment history
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Lamivudine/Zidovudine ViiV : Lamivudine / Zidovudine GSK-H-W-672-II-0011 - Scientific discussion (PDF/699.04 KB)
First published: 28/04/2009
Last updated: 21/12/2015
EMEA/H/C/0672/II/0011 -
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Lamivudine/Zidovudine ViiV : Procedural steps taken and scientific information after opinion (PDF/350.66 KB)
First published: 28/04/2009
Last updated: 21/12/2015 -
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Lamivudine/Zidovudine ViiV : Procedural steps taken before opinion (PDF/211.48 KB)
First published: 28/04/2009
Last updated: 21/12/2015 -
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Lamivudine/Zidovudine ViiV : Scientific discussion (PDF/279.08 KB)
First published: 28/04/2009
Last updated: 21/12/2015 -
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Lamivudine/Zidovudine ViiV : All presentations (PDF/190.64 KB)
First published: 28/04/2009
Last updated: 21/12/2015 -
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Lamivudine/Zidovudine ViiV : Public statement - Cessation of manufacture (PDF/67.47 KB)
First published: 28/04/2009
Last updated: 21/12/2015
EMA/849940/2015