Marketing Authorisation Holder Invented name Strength Pharmaceutical Form. Postinor 1500 Mikrogramm-Tablette
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1 Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of, marketing authorisation holders in the Member States 1
2 Levonorgestrel-containing emergency contraceptive medicinal products Member State Austria Austria Austria Austria Austria Belgium 15. rue Béranger Velvian GmbH Carl-Zeiss-Ring Ismaning Velvian GmbH Carl-Zeiss-Ring Ismaning Sandoz N.V. Telecom Gardens Medialaan Vilvoorde Belgium Postinor 1500 Mikrogramm-Tablette Vikela 750 Mikrogramm mg Tablet Oral use Tabletten Vikela 1,5 Milligramm- Tablette Velafam 1,5 mg Tabletten Velafam 750 Mikrogramm 0.75 mg Tablet Oral use Tabletten Levodonna 2
3 Belgium Belgium Belgium Belgium Bulgaria Bulgaria Bulgaria 15. rue Béranger Norlevo 0.75 mg Tablet Oral use Norlevo Postinor Postinor 0.75 mg Tablet Oral use Escapelle Ramonna Postinor-Duo 0.75 mg Tablet Oral use 3
4 Bulgaria Bulgaria Croatia Croatia Cyprus Cyprus Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, Villaquilambre,Leon Arenda d.o.o., Medarska ulica 56b Zagreb Croatia Sandoz d.o.o. Maksimirska 120 Zagreb Croatia Etiyone Melkidos 0.75 mg Tablet Oral use Vikela 1,5 mg tableta Escapelle Norlevo 0.75 mg Tablet Oral use Norlevo 4
5 Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Denmark Denmark Egis Pharmaceuticals PLC Keresztúri út H-1106 Budapest Laboratorios León Farma S.A. Calle La Vallina s/n Polígono Industrial Navatejera Navatejera - León Escapelle Postinor mg Tablet Oral use Ramonna Egianti 0,75 mg 0.75 mg Tablet Oral use Nopregy 1,5 mg tablety Norlevo 0.75 mg Tablet Oral use Norlevo 5
6 Denmark Estonia Estonia Estonia Estonia Estonia Estonia Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Orivas UAB J.Jasinskio 16B LT Vilnius Sandoz Pharmaceuticals Verovškova Ljubljana Slovenia Actavis Group PTC ehf Reykjavikurvegi Hafnarfjördur Iceland Orivas UAB J.Jasinskio 16B LT Vilnius Levodonna RAMONNA ESCAPELLE LEVIDON 0.75 mg Tablet Oral use LEVODONNA LEVONORGESTREL 0.75 mg Tablet Oral use ACTAVIS ELISTREL 6
7 Finland Finland MYLAN SAS 117, allée des Parcs Saint-Priest Norlevo 0.75 mg Tablet Oral use Norlevo ANTHIA mg Tablet Oral use microgrammes, comprimé LEVONORGESTREL BIOGARAN 1500 microgrammes, comprimé LEVONORGESTREL MYLAN 1,5 mg, comprimé NORLEVO 1,5 mg, comprimé NORLEVO mg Tablet Oral use microgrammes, comprimé 7
8 VELVIAN GmbH Carl-Zeiss-Ring Ismaning VELVIAN GmbH Carl-Zeiss-Ring Ismaning Hexal Aktiengesellschaft Industriestr Holzkirchen VIKELA 1,5 mg, comprimé VIKELA mg Tablet Oral use microgrammes, comprimé Navela 0,75 mg Tabletten 0.75 mg Tablet Oral use Navela 1,5 mg Tabletten PiDaNa 1,5 mg Tablette Postinor 1500 Mikrogramm Tablette unofem HEXAL 1,5 mg Tabletten 8
9 Greece Greece Greece Laboratorios Leon Farma, SA Poligono Industrial Navatejera C/La Vallina s/n Navatejera - Villaquilambre Egis Pharmaceuticals PLC Keresztúri út H-1106 Budapest Actavis Group PTC ehf Reykjavikurvegi Hafnarfjördur Iceland Etiyone 1500 Mikrogramm Tabletten NORLEVO 0.75 mg Tablet Oral use NORLEVO POSTINOR Escapelle Empil 0,75 mg tabletta 0.75 mg Tablet Oral use Helibona 9
10 Iceland Iceland Iceland Ireland Ireland Ireland Rigesoft 0.75 mg Tablet Oral use Norlevo Norlevo 0.75 mg Tablet Oral use Postinor Levonelle 1500 microgram Tablet NORLEVO mg Tablet Oral use micrograms tablet NORLEVO 1.5 mg tablet 10
11 Ireland Italy Italy Italy Latvia Latvia Latvia Laboratorios Leon Farma, S.A. C/ Roa de la Vega 15, Leon Tyedra 1500 micrograms tablet NORLEVO 0.75 mg Tablet Oral use NORLEVO LONEL Escapelle 1,5 mg tablets Ramonna 1500 micrograms tablets Postinor-Duo mg Tablet Oral use micrograms tablets 11
12 Latvia Latvia Latvia UAB Orivas J. Jasinskio g. 16B LT Vilnius UAB Orivas J. Jasinskio g. 16B LT Vilnius Actavis Group PTC ehf Reykjavikurvegi Hafnarfjördur Iceland UAB Orivas J. Jasinskio g. 16B LT Vilnius UAB Orivas J. Jasinskio g. 16B LT Vilnius Elistrel 1500 micrograms tablets Levidon 750 micrograms 0.75 mg Tablet Oral use tablets Levonorgestrel Actavis 0.75 mg Tablet Oral use 750 micrograms tablets ESCAPELLE RAMONNA Elistrel Levidon 0.75 mg Tablet Oral use 12
13 Luxembourg Luxembourg Luxembourg Luxembourg UAB Inteli Generics Nord Šeimyniškių 3 LT Vilnius UAB Inteli Generics Nord Šeimyniškių 3 LT Vilnius Avodele 0.75 mg Tablet Oral use Avodele POSTINOR-DUO 0.75 mg Tablet Oral use Norlevo 0.75 mg Tablet Oral use Norlevo Postinor 0.75 mg Tablet Oral use Postinor 13
14 Norway Norway Norway Norway Poland Poland Portugal Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Gedeon Richter Polska Sp. z o.o. 5 Ks. J. Poniatowskiego Street Grodzisk Mazowiecki Poland NORLEVO 0.75 mg Tablet Oral use NORLEVO POSTINOR Isteranda Escapelle tabletka 1500 mikrogramów Ramonna Norlevo 0.75 mg Tablet Oral use 14
15 Portugal Portugal Romania Romania Romania Slovak Republic Slovak Republic Gedeon Richter Romania S.A. Str. Cuza-Vodă nr Târgu Mureş Romania Norlevo Postinor ESCAPELLE RAMONNA POSTINOR mg Tablet Oral use micrograme ESCAPELLE Ramona 15
16 Slovak Republic Slovak Republic Slovenia Slovenia Slovenia Egis Pharmaceuticals PLC Keresztúri út H-1106 Budapest Actavis Group PTC ehf Reykjavikurvegi Hafnarfjördur Iceland Gyömrői út H-1103 Budapest Gyömrői út H-1103 Budapest CHIESI ESPAÑA, S.A. Plaça d Europa, planta L Hospitalet de Llobregat (Barcelona) EGIANTI 0,75 mg tablety 0.75 mg Tablet Oral use Helibona 1,5 mg Escapelle 1,5 mg tableta NORLEVO 1,5 mg tableta Ramonna 1,5 mg tableta Norlevo 750 microgramos 0.75 mg Tablet Oral use comprimidos 16
17 Sweden Sweden Sweden Sweden CHIESI ESPAÑA, S.A. Plaça d Europa, planta L Hospitalet de Llobregat (Barcelona) Actavis Group PTC ehf Reykjavikurvegi Hafnarfjördur Iceland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Norlevo 1500 microgramos comprimido Postinor 1500 microgramos comprimido Julirona 1,5 mg comprimido EFG NorLevo 0.75 mg Tablet Oral use NorLevo Levodonna Postinor 17
18 The Netherlands The Netherlands The Netherlands The Netherlands United Kingdom United Kingdom United Kingdom Perryment Ltd High street Esher, KT10 9QY Surrey Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR NorLevo, tabletten 0,75 mg 0.75 mg Tablet Oral use NorLevo 1,5 mg, tabletten Postinor 1500 microgram, tablet Vikela, tabletten mg Tablet Oral use microgram Isteranda 1.5mg Tablets Upostelle 1500 Microgram Tablets Levonelle mg Tablet Oral use Microgram Tablet 18
19 United Kingdom Levonelle 1500 Microgram Tablet United Kingdom Levonelle One Step 1500 Microgram Tablet / Boots Emergency Contraceptive 1.5 mg Tablet United Kingdom Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E Melkine 1.5mg Tablet 19
Marketing Authorisation Holder Invented name Strength Pharmaceutical Form. Postinor 1500 Mikrogramm-Tablette
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