Ioa

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Withdrawn

This medicine's authorisation has been withdrawn

nomegestrol acetate / estradiol
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 16 November 2011, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Ioa, which had been approved for oral contraception. The marketing authorisation holder (MAH) responsible for Ioa was Merck Sharp & Dohme Limited. 

On 31 July 2014, the European Commission issued a decision to withdraw the marketing authorisation for Ioa, following its receipt of a letter dated 18 June 2014 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. Ioa was not marketed in any European country. 

Pursuant to this decision, the European public assessment report for Ioa is updated to reflect that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: A31/0007
16/01/2014
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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).

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español (ES) (150.72 KB - PDF)

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čeština (CS) (183.01 KB - PDF)

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dansk (DA) (148.23 KB - PDF)

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Deutsch (DE) (148.4 KB - PDF)

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eesti keel (ET) (148.76 KB - PDF)

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ελληνικά (EL) (220.8 KB - PDF)

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français (FR) (150.84 KB - PDF)

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íslenska (IS) (148.5 KB - PDF)

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italiano (IT) (150.3 KB - PDF)

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latviešu valoda (LV) (221.2 KB - PDF)

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lietuvių kalba (LT) (215.68 KB - PDF)

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magyar (HU) (183.32 KB - PDF)

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Malti (MT) (219.35 KB - PDF)

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norsk (NO) (148.78 KB - PDF)

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polski (PL) (223.43 KB - PDF)

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português (PT) (148.74 KB - PDF)

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română (RO) (211.71 KB - PDF)

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slovenčina (SK) (183.46 KB - PDF)

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slovenščina (SL) (190.73 KB - PDF)

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Suomi (FI) (475.83 KB - PDF)

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svenska (SV) (150.3 KB - PDF)

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Product details

Name of medicine
Ioa
Active substance
  • Nomegestrol acetate
  • estradiol
International non-proprietary name (INN) or common name
  • nomegestrol acetate
  • estradiol
Therapeutic area (MeSH)
Contraception
Anatomical therapeutic chemical (ATC) code
G03AA14

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Oral contraception.

Authorisation details

EMA product number
EMEA/H/C/002068
Marketing authorisation holder
N.V. Organon

Kloosterstraat 6
5349 AB Oss
The Netherlands

Marketing authorisation issued
16/11/2011
Withdrawal of marketing authorisation
31/07/2014
Revision
4

Assessment history

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español (ES) (185.7 KB - PDF)

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čeština (CS) (254.72 KB - PDF)

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dansk (DA) (182.64 KB - PDF)

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Deutsch (DE) (190.2 KB - PDF)

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eesti keel (ET) (188.47 KB - PDF)

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ελληνικά (EL) (283.93 KB - PDF)

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français (FR) (184.17 KB - PDF)

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hrvatski (HR) (62.45 KB - PDF)

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italiano (IT) (185.08 KB - PDF)

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latviešu valoda (LV) (250.03 KB - PDF)

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lietuvių kalba (LT) (222.79 KB - PDF)

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magyar (HU) (243.38 KB - PDF)

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Malti (MT) (258.54 KB - PDF)

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polski (PL) (246.06 KB - PDF)

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português (PT) (183.28 KB - PDF)

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română (RO) (226.01 KB - PDF)

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slovenčina (SK) (248.6 KB - PDF)

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slovenščina (SL) (243.55 KB - PDF)

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Suomi (FI) (179.92 KB - PDF)

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svenska (SV) (185.37 KB - PDF)

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