# C_2019032EN.01000801.xml

| 25.1.2019 | EN | Official Journal of the European Union | C 32/8 |
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25.1.2019

EN

Official Journal of the European Union

C 32/8

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2018 to 31 December 2018

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2019/C 32/02)

| — | Issuing, maintenance or modification of a national marketing authorization |
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Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 18.12.2018 | Perlinring and associated names - | etonogestrel/ethinylestradiol | See annex | See annex | 19.12.2018 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.12.2018

Perlinring and associated names -

etonogestrel/ethinylestradiol

See annex

See annex

19.12.2018

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(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

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ANNEX

List of medicinal products and presentations

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg pro 24 Stunden — Vaginalring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Belgium | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg par 24 heures, système de diffusion vaginal /
  Perlinring 0,120  mg/0,015  mg per 24 uur, hulpmiddel voor vaginaal gebruik | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Croatia | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg tijekom 24 sata, sustav za isporuku u rodnicu | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Czech Republic | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Denmark | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Estonia | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Finland | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring
  0,120  mg/0,015  mg per 24 h depotlääkevalmiste, emättimeen | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| France | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 15 microgrammes/120 microgrammes/24 heures, système de diffusion vaginal | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Germany | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Hungary | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Iceland | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Ireland | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Italy | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Latvia | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 120/15 mikrogramu 24 stundās vaginālās ievadīšanas sistēma | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Lithuania | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Ongavia 120/15 mikrogramų/24 valandas vartojimo į makštį sistema | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| The Netherlands | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg per 24 uur, hulpmiddel voor vaginaal gebruik | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Norway | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Poland | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Portugal | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Romania | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg/24 ore sistem cu cedare vaginalã | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Slovak Republic | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Slovenia | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Etonogestrel/etinilestradiol Actavis 0,120  mg/0,015  mg na 24 ur vaginalni dostavni sistem | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Spain | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Pirlinring 0,120  mg/0,015  mg for cada 24 horas, sistema de liberación vaginal | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| Sweden | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |
| United Kingdom | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,015  mg/0,12  mg/ 24 hours Vaginal Delivery System | 0,120  mg/0,015  mg per 24 hours | Vaginal Delivery System | Vaginal use |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg pro 24 Stunden — Vaginalring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Belgium

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg par 24 heures, système de diffusion vaginal /

Perlinring 0,120  mg/0,015  mg per 24 uur, hulpmiddel voor vaginaal gebruik

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Croatia

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg tijekom 24 sata, sustav za isporuku u rodnicu

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Czech Republic

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Denmark

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Estonia

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Finland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 h depotlääkevalmiste, emättimeen

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

France

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 15 microgrammes/120 microgrammes/24 heures, système de diffusion vaginal

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Germany

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Hungary

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Iceland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Ireland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Italy

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Latvia

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 120/15 mikrogramu 24 stundās vaginālās ievadīšanas sistēma

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Lithuania

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Ongavia 120/15 mikrogramų/24 valandas vartojimo į makštį sistema

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

The Netherlands

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg per 24 uur, hulpmiddel voor vaginaal gebruik

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Norway

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Poland

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Portugal

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Romania

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg/24 ore sistem cu cedare vaginalã

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Slovak Republic

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Slovenia

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Etonogestrel/etinilestradiol Actavis 0,120  mg/0,015  mg na 24 ur vaginalni dostavni sistem

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Spain

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Pirlinring 0,120  mg/0,015  mg for cada 24 horas, sistema de liberación vaginal

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

Sweden

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

United Kingdom

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,015  mg/0,12  mg/ 24 hours Vaginal Delivery System

0,120  mg/0,015  mg per 24 hours

Vaginal Delivery System

Vaginal use

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