Ultratard

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Withdrawn

This medicine's authorisation has been withdrawn

insulin human (rDNA)
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 7 October 2002 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Ultratard, insulin human, 40 IU/ml and 100 IU/ml, 10 ml vial, which have been approved for treatment of diabetes mellitus. The marketing authorisation holder (MAH) responsible for Ultratard is NovoNordisk A/S. 

The European Commission was notified by the MAH of its decision through the MAH’s letter dated 25 September 2006 to voluntarily withdraw the marketing authorisation for Ultratard for commercial reasons. Therapeutic alternatives are available throughout the European Union. On 14 November 2006 the European Commission issued a decision to withdraw the marketing authorisation for Ultratard. 

Pursuant to this decision the European Public Assessment Report for Ultratard is updated to reflect that the marketing authorisation is no longer valid.

Ultratard : EPAR - Summary for the public

English (EN) (272.18 KB - PDF)

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español (ES) (273.69 KB - PDF)

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čeština (CS) (434.6 KB - PDF)

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dansk (DA) (273.48 KB - PDF)

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Deutsch (DE) (273.98 KB - PDF)

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eesti keel (ET) (272.68 KB - PDF)

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ελληνικά (EL) (452.79 KB - PDF)

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français (FR) (274.53 KB - PDF)

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italiano (IT) (273.4 KB - PDF)

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latviešu valoda (LV) (440.7 KB - PDF)

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lietuvių kalba (LT) (410.65 KB - PDF)

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magyar (HU) (427.98 KB - PDF)

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Nederlands (NL) (273.92 KB - PDF)

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polski (PL) (443.05 KB - PDF)

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português (PT) (274.1 KB - PDF)

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slovenčina (SK) (430.97 KB - PDF)

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slovenščina (SL) (423.26 KB - PDF)

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Suomi (FI) (273.09 KB - PDF)

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svenska (SV) (273.31 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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Product information

Ultratard : EPAR - Product Information

English (EN) (576.82 KB - PDF)

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español (ES) (625.5 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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dansk (DA) (614.06 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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Deutsch (DE) (650.19 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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ελληνικά (EL) (945.75 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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français (FR) (645.84 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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italiano (IT) (625.37 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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Nederlands (NL) (634.85 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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português (PT) (641.94 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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Suomi (FI) (611.13 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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svenska (SV) (612.31 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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07/10/2002
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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).

Ultratard : EPAR - All Authorised presentations

English (EN) (273.52 KB - PDF)

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español (ES) (275.39 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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čeština (CS) (316.37 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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dansk (DA) (274.94 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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Deutsch (DE) (277.86 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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eesti keel (ET) (272.44 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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ελληνικά (EL) (321.42 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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français (FR) (272.91 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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italiano (IT) (272.23 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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latviešu valoda (LV) (316.99 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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lietuvių kalba (LT) (293.36 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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magyar (HU) (317.14 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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Nederlands (NL) (273.37 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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polski (PL) (317.83 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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português (PT) (274.3 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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slovenčina (SK) (317.12 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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slovenščina (SL) (303.06 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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Suomi (FI) (271.53 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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svenska (SV) (273.97 KB - PDF)

First published: 15/02/2008 Last updated: 15/02/2008
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Product details

Name of medicine
Ultratard
Active substance
Insulin human
International non-proprietary name (INN) or common name
insulin human (rDNA)
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AE01

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus.

Authorisation details

EMA product number
EMEA/H/C/000439
Marketing authorisation holder
Novo Nordisk A/S

DK-2880 Bagsværd
Denmark

Marketing authorisation issued
07/10/2002
Withdrawal of marketing authorisation
14/11/2006

Assessment history

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

English (EN) (249.84 KB - PDF)

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Ultratard : EPAR - Procedural steps taken before authorisation

English (EN) (306.56 KB - PDF)

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Ultratard : EPAR - Scientific Discussion

English (EN) (592.57 KB - PDF)

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