Monotard

RSS

Withdrawn

This medicine's authorisation has been withdrawn

insulin human (rDNA)
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

Translate to Romanian | Important information about machine translation

  • 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 Monotard, 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 Monotard 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 Monotard 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 Monotard. 

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decision the European Public Assessment Report for Monotard is updated to reflect that the marketing authorisation is no longer valid.

Monotard : EPAR - Summary for the public

English (EN) (272.19 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

español (ES) (273.86 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

čeština (CS) (425.37 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

dansk (DA) (273.79 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

Deutsch (DE) (273.9 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

eesti (ET) (272.92 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

ελληνικά (EL) (455.13 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

français (FR) (274.59 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

italiano (IT) (273.59 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

latviešu (LV) (440.65 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

lietuvių (LT) (410.54 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

magyar (HU) (427.29 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

Nederlands (NL) (274.63 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

polski (PL) (443.15 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

português (PT) (273.88 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

slovenčina (SK) (431.73 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

slovenščina (SL) (423.48 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

suomi (FI) (273.29 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

svenska (SV) (273.29 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

Product information

Monotard : EPAR - Product Information

English (EN) (581.75 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

español (ES) (509.88 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

dansk (DA) (518.7 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

Deutsch (DE) (529.62 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

ελληνικά (EL) (953.54 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

français (FR) (530.38 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

italiano (IT) (517.19 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

Nederlands (NL) (518.82 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

português (PT) (516.93 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

suomi (FI) (509.34 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

svenska (SV) (513.56 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare
Latest procedure affecting product information:C/0440
25/04/2002
icon globe

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).

Monotard : EPAR - All Authorised presentations

English (EN) (273.38 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

español (ES) (273.56 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

čeština (CS) (316.47 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

dansk (DA) (275.34 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

Deutsch (DE) (278.02 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

eesti (ET) (272.64 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

ελληνικά (EL) (319.35 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

français (FR) (272.82 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

italiano (IT) (272.57 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

latviešu (LV) (316.75 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

lietuvių (LT) (293.6 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

magyar (HU) (317.06 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

Nederlands (NL) (273.42 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

polski (PL) (317.89 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

português (PT) (274.51 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

slovenčina (SK) (317.04 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

slovenščina (SL) (303.5 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

suomi (FI) (271.59 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

svenska (SV) (273.7 KB - PDF)

Prima publicare: 15/02/2008 Cea mai recent: 15/02/2008
Vizualizare

Product details

Name of medicine
Monotard
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
A10AC01

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus.

Authorisation details

EMA product number
EMEA/H/C/000440
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

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

English (EN) (292.01 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

Monotard : EPAR - Scientific Discussion

English (EN) (623.51 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

Monotard : EPAR - Procedural steps taken before authorisation

English (EN) (306.16 KB - PDF)

Prima publicare: Cea mai recent:
Vizualizare
This page was last updated on

Share this page