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 or Article 38 of Directive 2001/82/EC)
Date: 2019-01-25
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2019032EN.01000801.xml










25.1.2019   


EN


Official Journal of the European Union


C 32/8






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















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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




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