Overview

The marketing authorisation for Ioa has been withdrawn at the request of the marketing-authorisation holder.

Ioa : EPAR - Summary for the public

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magyar (HU) (291.03 KB - PDF)
Malti (MT) (231.29 KB - PDF)
Nederlands (NL) (255.31 KB - PDF)
polski (PL) (300.6 KB - PDF)
português (PT) (253.19 KB - PDF)
română (RO) (220.7 KB - PDF)
slovenčina (SK) (288.78 KB - PDF)
slovenščina (SL) (223.98 KB - PDF)
Suomi (FI) (266.53 KB - PDF)
svenska (SV) (256.38 KB - PDF)

Product information

Ioa : EPAR - Product information

български (BG) (1.35 MB - PDF)
español (ES) (741.36 KB - PDF)
čeština (CS) (1.03 MB - PDF)
dansk (DA) (701.96 KB - PDF)
Deutsch (DE) (734.07 KB - PDF)
eesti keel (ET) (704.08 KB - PDF)
ελληνικά (EL) (1.4 MB - PDF)
français (FR) (711.88 KB - PDF)
hrvatski (HR) (578.77 KB - PDF)
íslenska (IS) (791.5 KB - PDF)
italiano (IT) (702.78 KB - PDF)
latviešu valoda (LV) (1.1 MB - PDF)
lietuvių kalba (LT) (847.99 KB - PDF)
magyar (HU) (1.13 MB - PDF)
Malti (MT) (1.11 MB - PDF)
Nederlands (NL) (789.04 KB - PDF)
norsk (NO) (763.66 KB - PDF)
polski (PL) (1.17 MB - PDF)
português (PT) (693.57 KB - PDF)
română (RO) (824.37 KB - PDF)
slovenčina (SK) (1.11 MB - PDF)
slovenščina (SL) (1.07 MB - PDF)
Suomi (FI) (768.08 KB - PDF)
svenska (SV) (761.21 KB - PDF)

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.
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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).

Ioa : EPAR - All authorised presentations

български (BG) (224.18 KB - PDF)
español (ES) (150.72 KB - PDF)
čeština (CS) (183.01 KB - PDF)
dansk (DA) (148.23 KB - PDF)
Deutsch (DE) (148.4 KB - PDF)
eesti keel (ET) (148.76 KB - PDF)
ελληνικά (EL) (220.8 KB - PDF)
français (FR) (150.84 KB - PDF)
íslenska (IS) (148.5 KB - PDF)
italiano (IT) (150.3 KB - PDF)
latviešu valoda (LV) (221.2 KB - PDF)
lietuvių kalba (LT) (215.68 KB - PDF)
magyar (HU) (183.32 KB - PDF)
Malti (MT) (219.35 KB - PDF)
Nederlands (NL) (148.17 KB - PDF)
norsk (NO) (148.78 KB - PDF)
polski (PL) (223.43 KB - PDF)
português (PT) (148.74 KB - PDF)
română (RO) (211.71 KB - PDF)
slovenčina (SK) (183.46 KB - PDF)
slovenščina (SL) (190.73 KB - PDF)
Suomi (FI) (475.83 KB - PDF)
svenska (SV) (150.3 KB - PDF)

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
Revision
4

Assessment history

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

Ioa-H-C-2068-A31-1356 : EPAR - Assessment Report - Article 31

Ioa : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions

български (BG) (282.45 KB - PDF)
español (ES) (185.7 KB - PDF)
čeština (CS) (254.72 KB - PDF)
dansk (DA) (182.64 KB - PDF)
Deutsch (DE) (190.2 KB - PDF)
eesti keel (ET) (188.47 KB - PDF)
ελληνικά (EL) (283.93 KB - PDF)
français (FR) (184.17 KB - PDF)
hrvatski (HR) (62.45 KB - PDF)
italiano (IT) (185.08 KB - PDF)
latviešu valoda (LV) (250.03 KB - PDF)
lietuvių kalba (LT) (222.79 KB - PDF)
magyar (HU) (243.38 KB - PDF)
Malti (MT) (258.54 KB - PDF)
Nederlands (NL) (511.97 KB - PDF)
polski (PL) (246.06 KB - PDF)
português (PT) (183.28 KB - PDF)
română (RO) (226.01 KB - PDF)
slovenčina (SK) (248.6 KB - PDF)
slovenščina (SL) (243.55 KB - PDF)
Suomi (FI) (179.92 KB - PDF)
svenska (SV) (185.37 KB - PDF)

Ioa-H-C-2068-PSU-05 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Ioa : EPAR - Public assessment report

CHMP summary of positive opinion for Ioa

Topics

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