Vistide

RSS
Withdrawn

This medicine's authorisation has been withdrawn

cidofovir
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Vistide has been withdrawn at the request of the marketing authorisation holder.

Vistide : EPAR - Summary for the public

English (EN) (500.99 KB - PDF)

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български (BG) (683.27 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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español (ES) (510.76 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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čeština (CS) (651.25 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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dansk (DA) (510.55 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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Deutsch (DE) (49.8 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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eesti keel (ET) (509.68 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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ελληνικά (EL) (678.89 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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français (FR) (46.78 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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italiano (IT) (510.89 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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latviešu valoda (LV) (657.69 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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lietuvių kalba (LT) (624.07 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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magyar (HU) (642.89 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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Malti (MT) (656.55 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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Nederlands (NL) (511.31 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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polski (PL) (661.08 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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português (PT) (511.02 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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română (RO) (619.12 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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slovenčina (SK) (648.86 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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slovenščina (SL) (639.31 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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Suomi (FI) (48.65 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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svenska (SV) (510.09 KB - PDF)

First published: 27/01/2009Last updated: 19/01/2015
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Product information

Vistide : EPAR - Product Information

English (EN) (839.25 KB - PDF)

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български (BG) (1.63 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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español (ES) (851.78 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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čeština (CS) (1.32 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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dansk (DA) (842.26 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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Deutsch (DE) (333.47 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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eesti keel (ET) (856.23 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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ελληνικά (EL) (1.66 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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français (FR) (326.81 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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íslenska (IS) (767.64 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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italiano (IT) (845.86 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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latviešu valoda (LV) (1.39 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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lietuvių kalba (LT) (998.8 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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magyar (HU) (1.22 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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Malti (MT) (1.34 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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Nederlands (NL) (859.74 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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norsk (NO) (758.64 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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polski (PL) (1.36 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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português (PT) (853.79 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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română (RO) (992.29 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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slovenčina (SK) (1.3 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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slovenščina (SL) (1.25 MB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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Suomi (FI) (302.19 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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svenska (SV) (852.21 KB - PDF)

First published: 12/11/2009Last updated: 19/01/2015
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Latest procedure affecting product information: N/0034
22/08/2014
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Vistide : EPAR - All Authorised presentations

English (EN) (466.42 KB - PDF)

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български (BG) (475.83 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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español (ES) (475.88 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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čeština (CS) (525.05 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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dansk (DA) (15.54 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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Deutsch (DE) (475.47 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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eesti keel (ET) (476.17 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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ελληνικά (EL) (533.86 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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français (FR) (475.8 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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íslenska (IS) (475.64 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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italiano (IT) (475.96 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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latviešu valoda (LV) (531.39 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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lietuvių kalba (LT) (510.3 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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magyar (HU) (504.02 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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Malti (MT) (508.21 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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Nederlands (NL) (475.97 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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norsk (NO) (475.94 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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polski (PL) (529.64 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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português (PT) (475.95 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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slovenčina (SK) (521.04 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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slovenščina (SL) (487.91 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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Suomi (FI) (480.44 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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svenska (SV) (476.44 KB - PDF)

First published: 31/08/2006Last updated: 19/01/2015
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Product details

Name of medicine
Vistide
Active substance
cidofovir
International non-proprietary name (INN) or common name
cidofovir
Therapeutic area (MeSH)
Cytomegalovirus Retinitis
Anatomical therapeutic chemical (ATC) code
J05AB12

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.

Authorisation details

EMA product number
EMEA/H/C/000121
Marketing authorisation holder
Gilead Sciences International Limited

Cambridge
CB21 6GT
United Kingdom

Marketing authorisation issued
23/04/1997
Revision
21

Assessment history

Vistide : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (645.02 KB - PDF)

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Vistide-H-C-121-A20-35 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/303411/2012

English (EN) (572.91 KB - PDF)

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Vistide : EPAR - Steps taken after authorisation when a cutoff date has been used

English (EN) (554.98 KB - PDF)

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Vistide : EPAR - Procedural steps taken before authorisation

English (EN) (538.59 KB - PDF)

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Vistide : EPAR - Scientific Discussion

English (EN) (691.28 KB - PDF)

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More information on Vistide

Public statement on Vistide: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMEA/H/C/000121

English (EN) (72.85 KB - PDF)

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Final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories

Reference Number: EMA/106872/2012

English (EN) (188.14 KB - PDF)

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Questions and answers on shortcomings in quality assurance at Ben Venue Laboratories

Reference Number: EMA/946321/2011

English (EN) (71.91 KB - PDF)

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Shortages

Questions and answers on the shortage of Vistide

Reference Number: EMA/101129/2013

English (EN) (70.29 KB - PDF)

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