- 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this decision, the European public assessment report for Ioa is updated to reflect that the marketing authorisation is no longer valid.
Ioa : EPAR - Summary for the public
English (EN) (195.71 KB - PDF)
български (BG) (380.65 KB - PDF)
español (ES) (200.54 KB - PDF)
čeština (CS) (246.32 KB - PDF)
dansk (DA) (261.29 KB - PDF)
Deutsch (DE) (203.85 KB - PDF)
eesti keel (ET) (215.74 KB - PDF)
ελληνικά (EL) (341.84 KB - PDF)
français (FR) (256.63 KB - PDF)
italiano (IT) (192.15 KB - PDF)
latviešu valoda (LV) (304.54 KB - PDF)
lietuvių kalba (LT) (218.61 KB - PDF)
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
English (EN) (738.45 KB - PDF)
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)
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).
Ioa : EPAR - All authorised presentations
English (EN) (126.7 KB - PDF)
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 systemTherapeutic 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
Ioa : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (225.07 KB - PDF)
Ioa-H-C-2068-A31-1356 : EPAR - Assessment Report - Article 31
English (EN) (693.91 KB - PDF)
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
English (EN) (214.3 KB - PDF)
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
English (EN) (206.2 KB - PDF)