natgillin/translations-raw huggingface dataset:
The starting dose is 30 mg once a day and the dose is increased every week according to the schedule shown in the package leaflet until the psoriasis starts improving or until the patient is taking the maximum dose of 240 mg three times a day. 
Algannus on 30 mg üks kord ööpäevas ja annust suurendatakse igal nädalal vastavalt pakendi infolehel esitatud tabelile, kuni psoriaas hakkab paranema või kuni patsient võtab maksimumannust 240 mg kolm korda ööpäevas.
The main measure of effectiveness was the proportion of patients who achieved a 75% reduction in their score for disease severity. 
Peamine efektiivsusnäitaja oli nende patsientide osakaal, kellel haiguse raskusastet kajastav skoor vähenes 75% võrra.
What is Skilarence and what is it used for? 
Mis on Skilarence ja milleks seda kasutatakse?
Psoriasis results from over-activity of the body's immune (defence) system. 
Psoriaas on põhjustatud immuunsüsteemi (organismi kaitsesüsteemi) liigaktiivsusest.
Why is Skilarence approved? 
Miks Skilarence heaks kiideti?
The CHMP considered that the main study has shown Skilarence's short-term effectiveness, and published studies with similar medicines show that the effectiveness is maintained with continued use. 
Inimravimite komitee arvates tõendas põhiuuring Skilarence'i lühiajalist efektiivsust ning sarnaste ravimitega tehtud avaldatud uuringutest nähtub, et efektiivsus püsib ka pikemaajalisel kasutamisel.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Skilarence's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Inimravimite komitee otsustas, et Skilarence'i kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% taking placebo and 40% taking Fumaderm . 
Pärast 16 ravinädalat saavutas sellise vähenemise 37% Skilarence'i võtnud patsientidest, samas kui platseeborühmas oli see näitaja 15% ja Fumadermi rühmas 40%.
This is a summary of the European public assessment report (EPAR) for Skilarence. 
See on ravimi Skilarence Euroopa avaliku hindamisaruande kokkuvõte.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skilarence have also been included in the summary of product characteristics and the package leaflet. 
Skilarence'i ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
A main study involving 704 patients with moderate to severe plaque psoriasis found that Skilarence was more effective than placebo (dummy treatment) at treating the disease and as effective as Fumaderm (a psoriasis medicine that contains dimethyl fumarate and monoethyl fumarate). 
Põhiuuringus, milles osales 704 mõõduka kuni raske naastulise psoriaasiga patsienti, osutus Skilarence haiguse ravis efektiivsemaks kui platseebo (näiv ravim) ning sama efektiivseks kui Fumaderm (dimetüülfumaraati ja monoetüülfumaraati sisaldav psoriaasiravim).
It is not intended to provide practical advice on how to use Skilarence. 
Hindamisaruandes ei anta Skilarence'i kasutamise praktilisi nõuandeid.
It is used in patients with moderate or severe disease for whom treatments applied direct to the skin do not work well enough. 
Seda kasutatakse mõõduka või raske naastulise psoriaasiga patsientidel, kel nahale kantavad ravimid ei toimi piisavalt hästi.
It must also not be used by women during pregnancy or if breast-feeding. 
Samuti ei tohi Skilarence'i kasutada raseduse ega imetamise ajal.
Because Skilarence reduces the activity of the immune system, there is a risk of serious infections, including progressive multifocal leukoencephalopathy (PML, a brain infection), but the risk can be minimised by regular tests for white blood cell counts and stopping treatment if necessary. 
Kuna Skilarence vähendab immuunsüsteemi aktiivsust, esineb patsientidel risk raskekujuliste infektsioonide, sealhulgas progresseeruva multifokaalse leukoentsefalopaatia (ajuinfektsiooni) tekkeks, kuid seda riski on võimalik minimeerida leukotsüütide arvu korrapärase jälgimise ja vajadusel ravi katkestamisega.
Skilarence contains the active substance dimethyl fumarate. 
Skilarence sisaldab toimeainena dimetüülfumaraati.
How does Skilarence work? 
Kuidas Skilarence toimib?
The active substance in Skilarence, dimethyl fumarate, reduces the activity of the immune system. 
Skilarence'i toimeaine dimetüülfumaraat vähendab immuunsüsteemi aktiivsust.
The most common side effects with Skilarence (which may affect more than 1 in 10 people) are effects on the digestive system (diarrhoea, bloating, belly ache and nausea), flushing (reddening of the skin) and low levels of lymphocytes (type of white blood cells) or of white blood cells in general. 
Skilarence'i kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on seedetrakti häired (kõhulahtisus, kõhupuhitus, kõhuvalu ja iiveldus), õhetus ja lümfotsüütide (teatud leukotsüütide) või üldiselt leukotsüütide arvu vähenemine.
It is thought to act on T cells (a type of white blood cell that forms part of the immune system) to prevent the cells from producing substances that cause inflammation and lead to psoriasis. 
Arvatavalt mõjutab see T-rakke (teatud leukotsüüdid, mis on immuunsüsteemi osa), takistades neid tootmast põletikku ja psoriaasi põhjustavaid aineid.
Skilarence can only be obtained with a prescription and it should be used under the supervision of a doctor who has experience in diagnosing and treating psoriasis. 
Skilarence on retseptiravim ning seda tohib kasutada psoriaasi diagnostikas ja ravis kogenud arsti järelevalve all.
What are the risks associated with Skilarence? 
Mis riskid Skilarence'iga kaasnevad?
Skilarence must not be used in patients who have severe problems of the digestive system, liver or kidneys. 
Skilarence'i ei tohi kasutada raskete seedetrakti häirete, maksa- või neeruprobleemidega patsiendid.
Skilarence is a medicine used to treat plaque psoriasis, a disease that causes thickened, red and inflamed areas of skin with scaly patches. 
Skilarence on ravim, millega ravitakse naastulist psoriaasi (haigus, mis põhjustab nahal paksenenud, põletikulisi, punetavaid ja ketendavaid laike).
For practical information about using Skilarence, patients should read the package leaflet or contact their doctor or pharmacist. 
Kui vajate Skilarence'i kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
For more information about treatment with Skilarence, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate Skilarence'iga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
For the full list of all side effects reported with Skilarence, see the package leaflet. 
Skilarence'i kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
The company that markets Skilarence will supply educational materials to healthcare professionals about the risk of serious infections, including PML, and how to minimise this risk. 
Skilarence'i turustaja varustab tervishoiutöötajad teabematerjaliga, milles neid teavitatakse raskekujuliste infektsioonide (sh progresseeruva multifokaalse leukoentsefalopaatia) riskist ja selle minimeerimise võimalustest.
The doctor may reduce the dose when the psoriasis has been brought under control. 
Kui psoriaas on kontrolli all, võib arst annust vähendada.
How is Skilarence used? 
Kuidas Skilarence'i kasutatakse?
What benefits of Skilarence have been shown in studies? 
Milles seisneb uuringute põhjal Skilarence'i kasulikkus?
This summary was last updated in 06-2017. 
Skilarence EMA/377390/2017
"ARAC" At Regulatory Affairs Consulting GmbH 
Saksamaa "ARAC" At Regulatory Affairs Consulting GmbH
PARANOVA Rajatorpantie 41 C 01640 Vantaa Finland 
Paranova Oy Rajatorpantie 41 C 01640 Vantaa Finland
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Combined hormonal contraceptives 
LISA I Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, müügiloa hoidjate loetelu liikmesriikides
Graniczna 35 
ul.Graniczna 35
JANSSEN-CILAG 1 rue Camille Desmoulins TSA 91003 
Prantsusmaa Janssen-Cilag 1 rue Camille Desmoulins TSA 91003
Frederic Mompou, 5 08960 Sant Just Desvern 
Frederic Mompou, 5 08960 Sant Just Desvern Barcelona
Otto-Schott-Straße 15 
KG Otto-Schott-Straße 15
1 28700 San Sebastián de los ReyesMadrid 
1 28700 San Sebastián de los Reyes
Belgium EFFIK BENELUX Lenniksebaan 451 
Luksemburg EFFIK BENELUX Lenniksebaan 451
STRAGEN France SAS 52 rue de la République 69002 Lyon France 
Prantsusmaa STRAGEN France SAS 52 rue de la République 69002 Lyon
Farmaceuticos, Lda Edifício Cyprium, Av. 25 de Abril, 15, 2º F 2795-195 Linda-aVelha 
Teva Pharma - Produtos Farmaceuticos, Lda Edifício Cyprium, Av. 25 de Abril, 15, 2º F 2795-195 Linda-a-Velha Portugal
CHEMICAL FARMA 3, Quai Louis Blériot 75016 PARIS FRANCE 
Prantsusmaa CHEMICAL FARMA 3, Quai Louis Blériot 75016 Paris
Zentiva Pharma GmbH Industriepark Frankfurt-Höchst, Gebäude K703 
Saksamaa Zentiva Pharma GmbH Industriepark FrankfurtHöchst, Gebäude K703
Teva The Netherlands B.V. 
Teva Nederland B.V.
Teva Danmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, 
Teva Danmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark
Rua João de Deus, 19 2700-487 Amadora Portugal 
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal
Alameda da Beloura Edificio 1, 2º Escritorio 15 
Alameda da Beloura Edificio 1, 2º
Bayer Sante 220 avenue de la Recherche 59120 Loos France 
Prantsusmaa Bayer Sante 220 avenue de la Recherche 59120 Loos
Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungary gestodene ethinylestradiol 
Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungary
1070 Anderlecht 
1070 Anderlecht Belgium
CT 13 9NJ 
Kent CT13 9NJ
Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany 
Saksamaa Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Nagano III, U 
Nagano III,
BIAL INDUSTRIAL FARMACEUTICA, S.A. Parque Científico y Tecnológico de Bizkaia, 
Parque Científico y Tecnológico de Bizkaia,
Mylan dura gmbH Wittstichstr. 
Saksamaa Mylan dura gmbH Wittstichstr.
Merck Sharp and Dohme de España, S.A Josefa Valcárcel, 38 28027 Madrid Spain 
Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38 28027 Madrid España (Spain)
Luxembourg Teva Pharma Belgium N.V. 
Luksemburg Teva Pharma Belgium N.V.
Janssen - Cilag Pharma GmbH Vorgartenstraße 206b A-1020 Wien Austria 
Janssen - Cilag Pharma GmbH Vorgartenstraße 206b A-1020 Wien
60389 Frankfurt Germany 
60389 Frankfurt
Slovak Republic Actavis Group PTC ehf Reykjavikurvegi 76-78 
Saksamaa Actavis Group PTC ehf Reykjavikurvegi 76-78
WYETH MEDICA IRELAND Newbridge Ireland 
WYETH MEDICA IRELAND Little Connell Newbridge
Teva Pharmaceuticals Bulgaria EOOD Gogol 15 
Teva Pharmaceuticals Bulgaria EOOD
BAYER HELLAS AG Sorou 18-20 
BAYER HELLAS AG Sorou street 18-20 Maroussi
Belgium Teva Pharma Belgium N.V. 
Teva Pharma Belgium N.V.
48170 Zamudio Vizcaya 
48170 Zamudio (Vizcaya) Spain
A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 
A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - 50131 Florence
Aktiengesellschaft Industriestr. 
Saksamaa Hexal Aktiengesellschaft Industriestr.
Famy Care Europe Ltd. One Wood Street EC2V 7WS 
Famy Care Europe Ltd One Wood Street EC2V 7WS London United Kingdom
154 51 N. Psychiko, Greece 
243 Messoghion Avenue, 154 51 N. Psychiko, Greece
Stadapharm GmbH Stadastr. 
Saksamaa Stadapharm GmbH Stadastr.
Czech Republic Pfizer, spol. 
Pfizer, spol.
1541 KA Koog aan de Zaan, 
1541 KA Koog aan de Zaan, The Netherlands
Pfizer Pharma GmbH Linkstr. 
Saksamaa Pfizer Pharma GmbH Linkstr.
Morningside Healthcare Limited, 115 Narborough Road, Leicester LE3 0PA United Kingdom 
115 Narborough Road, Leicester LE3 0PA United Kingdom
MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1 
Saksamaa MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung
Luxembourg PFIZER S.A. 17 Boulevard de la Plaine 
Luksemburg PFIZER S.A. 17 Boulevard de la Plaine 1050 Brussels
83607 Holzkirchen Germany 
83607 Holzkirchen
92787 ISSY LES MOULINEAUX cedex 9 FRANCE 
92787 Issy-les-Moulineaux cedex 9
Slovak Republic VIVAX EuroAsia s.r.o. 
VIVAX EuroAsia s.r.o.
C/Roa de la Vega 15 1-24008 Leon Spain 
Laboratorios Leon Farma SA C/Roa de la Vega 15 1-24008 Leon Spain
89150 Laichingen Germany 
89150 Laichingen
Gyömrői út 19-21 HU-1103 Budapest Hungary 
Gyömrői ut 19-21, H-1103 Budapest, Hungary
Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania 
UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania
Micrograms Film-Coated Tablets 
Micrograms FilmCoated Tablets
Aristo Pharma GmbH Wallenroder Straße 8 
Saksamaa Aristo Pharma GmbH Wallenroder Straße 8-10
540306 Târgu Mureş România 
540306 Târgu Mureş
1000 Ľubľana Slovenia 
1000 Ľubľana
Slovak Republic Bayer, spol. 
Bayer, spol.
Millinette ED Micrograms Film-Coated Tablets 15 / 
Millinette ED Micrograms FilmCoated Tablets 15 /
Aliud Pharma GmbH Gottlieb-Daimler-Str. 
Saksamaa Aliud Pharma GmbH Gottlieb-Daimler-Str. 19
N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands 
Organon Kloosterstraat 6 5349 AB, Oss The Netherlands
Janssen-Cilag A/S, Postbox 149, Hammerbakken 19, DK-3460 Birkerød, Denmark 
Janssen-Cilag A/S, Hammerbakken 19 DK-3460 Birkerød Denmark
The Netherlands betapharm Arzneimittel GmbH Kobelweg 95 
Holland betapharm Arzneimittel GmbH Kobelweg 95
Pharmaceuticals GmbH Raiffeisenstr. 
Saksamaa Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Yarina 3000/30 micrograms film-coated tablets 
Yarina 3000/30 micrograms filmcoated tablets
Slovak Republic LADEEPHARMA Slovakia s.r.o. 
LADEEPHARMA Slovakia s.r.o.
Janssen-Cilag GmbH Johnson & Johnson Platz 1 
Saksamaa Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss
Luxembourg BAYER N.V. J.E. 
Luksemburg BAYER SA-NV J.E.
Luxembourg Madaus GmbH Colonia Allee 15 
Luksemburg Madaus GmbH Colonia Allee 15
Ethinylestradiol Dienogest maxim 
Dienogest Ethinylestradiol maxim
2770-192 Paço d' Arcos 
Edificio Vasco da Gama 2770-192 Paço d' Arcos Portugal
Farmaceutyczne POLPHARMA S.A. ul. 
Zakłady Farmaceutyczne POLPHARMA S.A. ul.
Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide Portugal 
Rua Quinta Pinheiro, 5 2794-003 Carnaxide Portugal
12 rue Danjou 92517 BOULOGNE BILLANCOURT cedex FRANCE 
92517 Boulogne Billancourt Cedex France
Czech Republic Janssen-Cilag s.r.o. 
Janssen-Cilag s.r.o.
Luxembourg Ratiopharm GmbH Graf-Arco-Strasse 3 
Luksemburg Ratiopharm GmbH Graf-Arco-Strasse 3
Czech Republic LadeePharma Kft Lajos utca 48-66. 
Rumeenia LadeePharma Kft Lajos utca 48-66
95-200 Pabianice Poland 
Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland
2740-271 Porto Salvo Portugal 
Lagoas Park, Edificio 10 2740-271 Porto Salvo Portugal
Jeanine 2000/30 micrograms film-coated tablets 
Jeanine 2000/30 micrograms filmcoated tablets
DORINELLETEVA CONTINU 0.02 mg 3.00 mg 
DORINELLETEVA 0.02 mg 3.00 mg
49 avenue Georges Pompidou 92593 LEVALLOISPERRET Cedex FRANCE 
Prantsusmaa SANDOZ 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex France
Germany betapharm Arzneimittel GmbH Kobelweg 95 
Saksamaa betapharm Arzneimittel GmbH Kobelweg 95
LABORATOIRES CRISTERS 22, quai Galliéni 92150 SURESNES FRANCE 
Prantsusmaa LABORATOIRES CRISTERS 22, quai Galliéni
Czech Republic WH-Pharma s.r.o. 
WH-Pharma s.r.o.
9960 Assenede Belgium 
MPCA BVBA Vrijestraat 28 9960 Assenede Belgium
Clonmel Healthcare Ltd 
Clonmel Healthcare Ltd Waterford Road Clonmel
Vaginal ring 
Stunden - Vaginalring
Farmaceutiche Via Alcide De Gasperi, 165 B 
Farmitalia Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B 95127 Catania Italy
DK-2300 København S Denmark 
Edward Thomsens Vej 14 DK-2300 København S Denmark
BIOGARAN 15 Bd Charles de Gaulle 
Prantsusmaa BIOGARAN 15 Bd Charles de Gaulle 92700 Colombes France
S.C. SANDOZ S.R.L. 
Rumeenia S.C. SANDOZ S.R.L.
LadeePharma LTD. Lajos street 48-66 E Budapest 1036 
LadeePharma Kft Lajos utca 48-66 H-1036 Budapest Hungary
Ethinylestradiol/gestodeen 0,015/0,060 A filmomhulde tabletten 0,015/0,060 mg 
Ethinylestradiol/gesto deen 0,015/0,060 A filmomhulde tabletten 0,015/0,060 mg
ETHINYLESTRADIOL/DRO SPIRENON ORIFARM 
ETHINYLESTRADIOL/ DROSPIRENON ORIFARM
Stada Arzneimittel GmbH Muthgasse 36/2 1190 Wien 
Stada Arzneimittel GmbH Muthgasse 36/2
Regulon 150/30 micrograms film-coated tablets 
Regulon 150/30 micrograms filmcoated tablets
1-13 boulevard Romain Rolland 75014 PARIS FRANCE 
Prantsusmaa SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland 75014 Paris
Einsteinova 25 
Digital Park II Einsteinova 25
Ethinylestradiol/Desogestr el Richter 150 microgram/30 microgram -28 filmomhulde tabletten 
Ethinylestradiol/Deso gestrel Richter 150 microgram/30 microgram -28 filmomhulde tabletten
Lusal - Producao Quimico-Farmaceutica Luso-Alema, Lda. 
Lusal, Produção Químico Farmacêutica Luso Alemã, Lda.
Gurtnafleur, Clonmel Ireland 
Tipperary Clonmel Ireland
Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège Belgium 
Rue Saint Georges 5 4000 Liège
Milton Road, Cambridge CB4 0FL, 
CB4 0FL,
GRACIAL comprimido 
GRACIAL comprimidos
25 Rue des peuliers 92752 NANTERRE CEDEX 
Prantsusmaa ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France
1-3 Ruse Caumartin, Paris 75009, France 
Gedeon Richter France, 1-3 Ruse Caumartin, Paris 75009, France
Slovak Republic Teva Pharmaceuticals Slovakia s.r.o. 
Teva Pharmaceuticals Slovakia s.r.o.
Novynette Plus 150 micrograms/ 20 micrograms film-coated tablets 
Novynette Plus 150 micrograms/ 20 micrograms filmcoated tablets
Belgium Madaus GmbH Colonia Allee 15 
Saksamaa Madaus GmbH Colonia Allee 15
Femoden 75/30 micrograms film-coated tablets 
Femoden 75/30 micrograms filmcoated tablets
Jenapharm GmbH & Co. KG 
Saksamaa Jenapharm GmbH & Co.
08228 Tarrasa Barcelona 
Polígono Industrial Colón II 08228 Tarrasa Barcelona
Medico Uno Pharma Kft. 
Q Pharma Kft.
Novynette 150/20 microgram film-coated tablets 
Novynette 150/20 microgram filmcoated tablets
Czech Republic Zentiva, k.s. 
Rumeenia Zentiva, k.s.
ARROW GENERIQUES 26 avenue Tony Garnier 
Prantsusmaa Arrow Generiques 26 avenue Tony Garnier 69007 Lyon
Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien 
Floridsdorfer Hauptstraße 1 1210 Wien
13435 Berlin Germany 
13435 Berlin
Belgium L.F. WILL & CIE SA Rue du Manil 80 
WILL & CIE SA Rue du Manil 80 1301 Wavre Belgium
Belgium N.V. Organon Kloosterstraat 6 
Organon Kloosterstraat 6
SE-16926 Solna Sweden 
Gustav III's Boulevard 56 SE-16926 Solna Sweden
Slovak Republic Ratiopharm GmbH Graf-Arco-Strasse 3 
Saksamaa Ratiopharm GmbH Graf-Arco-Strasse 3
13000 Praha - 3 Czech Republic 
150 00 Praha 5 - Smíchov Czech Republic
NOVYNETTE PLUS 
NOVYNETTE CONTINUU
851 01 Bratislava 
851 01 Bratislava Slovak republic
Emilii Plater 53 00-113 Warszawa Poland 
00-113 Warszawa Poland
Mirelle 60/15 micrograms film-coated tablets 
Mirelle 60/15 micrograms filmcoated tablets
Desogestrel/Ethinylestradi ol Actavis 150/30 microgram tabletten 
Desogestrel/Ethinyles tradiol Actavis 150/30 microgram tabletten
Czech Republic Pharbil Waltrop GmbH Im Wirrigen 25 
Saksamaa Pharbil Waltrop GmbH Im Wirrigen 25
Desogestrel/Ethinylestradi ol Actavis 150/20 microgram tabletten 
Desogestrel/Ethinyles tradiol Actavis 150/20 microgram tabletten
Gestodene/Ethinylestradiol Actavis 
Gestodene/Ethinylest radiol Actavis
Vaginal device 
Vaginaalravivahend Vaginaalne
CT Arzneimittel GmbH Graf-Arco-Str. 3 
Saksamaa TEVA GmbH Graf-Arco-Str. 3
Cambridge Science Park, 
Organon Laboratories Limited, Cambridge Science Park, Milton Road,
Teva Pharmaceuticals S.R.L. 
Rumeenia Teva Pharmaceuticals S.R.L.
Belgium BAYER N.V. J.E. 
BAYER SA-NV J.E.
Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Lithuania 
Ladee Pharma Baltics UAB Žemaitijos g.13/Šiaulių g.10, LT-01134 Vilnius Lithuania
Berlex - Especialidades Farmaceuticas, Lda. 
Berlex Especialidades Farmacêuticas Lda.
Slovak Republic Ivowen Limited 3, Anglesea Street Clonmel 
Rumeenia Ivowen Limited 3 Anglesa St
PHARMACEUTICALS S.L. 
MYLAN PHARMACEUTICALS S.L.
Ethinylestradiol/gestodeen 0,03/0,075 A, omhulde tabletten 0,03 mg/0,075 mg 
Ethinylestradiol/gesto deen 0,03/0,075 A, omhulde tabletten 0,03 mg/0,075 mg
Slovensko 
Slovakkia
Harmonette - Dragees 0,02 mg 0,075 mg 
Meliane - Dragees 0,02 mg 0,075 mg
FARMACEUTICA, S.A. Avda. 
SANDOZ FARMACEUTICA, S.A. Avda.
DESOGESTREL/ETHINYLE STRADIOL ACTAVIS 
GESTODEN/ETHINYLE STRADIOL ACTAVIS
Ethinylestradiol/gestodeen 0,02/0,075 A, omhulde tabletten 0,02 mg/0,075 mg 
Ethinylestradiol/gesto deen 0,02/0,075 A, omhulde tabletten 0,02 mg/0,075 mg
3 mg 0.020 mg/0.030 mg 
3 mg/0.020 mg 3 mg/0.030 mg
TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Island ratiopharm GmbH Graf-Arco Strasse 3 89079 ULM Germany
BAYER SCHERING PHARMA AG Müllerstrasse 178 D-13342 Berlin Germany 
Bayer Pharma AG Müllerstrasse 178 D-13342 Berlin Germany
Violetta 60 micrograms/15 micrograms film-coated tablets 
Violetta 60 micrograms/15 micrograms filmcoated tablets
Ethinylestradiol/Drospiren on 24+4 0,02 mg/3 mg Berlipharm filmomhulde tabletten 
Ethinylestradiol/Dros pirenon 24+4 0,02 mg/3 mg Berlipharm filmomhulde tabletten
Kichengasse 48/3 1070 Wien 
Kichengasse 48/3
1831 Diegem Belgium 
Mommaertslaan 14 1831 Diegem Belgium
Laboratorios Leon Farma SA 
LEON FARMA
Sylgestrel 75 Mikrogramm + 30 Mikrogramm Dragees 
Mikrogramm + 30 Mikrogramm Dragees
821 08 Bratislava 
821 08 Bratislava Slovak republic
VONILLE 60 micrograms/15 micrograms film-coated tablets 
VONILLE 60 micrograms/15 micrograms filmcoated tablets
Bayer House, Strawberry Hill Newbury RG14 1JA, Berkshire 
Bayer PLC Bayer House Strawberry Hill Newbury
5026 RH TILBURG The Netherlands 
Dr. Paul Janssenweg 150 5026 RH Tilburg The Netherlands
Qlaira film-coated tablets 3 mg 2 mg/2 mg 
Qlaira Filmtabletten 3 mg 2 mg/2 mg
LABORATORIOS EFFIK, S.A. 
LABORATORIOS EFFIK, S.A. San Rafael, 3
LABORATORIOS, S.L. 
GYNEA LABORATORIOS, S.L.
Hexal GmbH Stella-Klein-Löw-Weg 
Hexal GmbH Stella-Klein-Löw-Weg 17 1020 Wien
Tietokuja 4 
PFIZER Oy Tietokuja 4
Ivowen Limited 3, Anglesea Street Clonmel 
Ivowen Limited 3 Anglesa St Tipperary Clonmel Ireland
Ethinylestradiol Drospirenon 
Ethinylestradiol Drospirenone
TEVA SANTE 110 Esplanade du Général de Gaulle 92931 PARIS LA DEFENSE CEDEX FRANCE 
Prantsusmaa TEVA SANTE 110 Esplanade du Général de Gaulle
Varipharm Arzneimittel GmbH 
Kade Pharmazeutische Fabrik GmbH
Gestoden/ethinylestradiol 75/30 Mylan 
Gestoden/ethinylestra diol 75/30 Mylan
GAIA 0,15 MG/0,02 MG 0,15 mg 0,02 mg 
GAIA 0,15 MG/0,02 MG
Rua Consiglieri Pedroso, 123Barcarena 
Rua Consiglieri Pedroso, 123 2730-056 Barcarena Portugal
Ethinylestradiol/Drospiren on Richter 0,03 mg/3 mg filmomhulde tabletten 28x 
Ethinylestradiol/Dros pirenon Richter 0,03 mg/3 mg filmomhulde tabletten 28x
BerlifarmaEspecialidades Farmacêuticas, Lda. 
Berlifarma, Especialidades Farmacêuticas, Lda.
821 02 Bratislava 
821 02 Bratislava Slovak republic
Piłsudskiego 5 
Swensweg 5
Gestoden/ethinylestradiol 75/20 Mylan 
Gestoden/ethinylestra diol 75/20 Mylan
Zemaitijos g.13/Siauliu g.10 Vilnius LT-01134 Lithuania 
UAB „Ladee Pharma Baltics“ Zemaitijos g.13/Siauliu g.10 Vilnius LT-01134
Ethinylestradiol Dienogest vatrice 0,03 mg/2 mg Filmtabletten 
Dienogest Ethinylestradiol vatrice 0,03 mg/2 mg Filmtabletten
Bellmunt 28 Film-coated Tablets 0.03 mg/3 mg 
Bellmunt 28 Filmcoated Tablets 0.03 mg/3 mg
Calle La Vallina S/N Poligono Industrial Navatejera 
Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera,
Luxembourg JANSSEN-CILAG N.V. Antwerpseweg 15-17 
Luksemburg JANSSEN-CILAG N.V.
Ethinylestradiol/Drospiren on Sandoz 0,03/3 mg, filmomhulde tabletten 
Ethinylestradiol/Dros pirenon Sandoz 0,03/3 mg, filmomhulde tabletten
0.12 mg/0.015 mg Vaginal delivery system 
0.12 mg/0.015 mg Vaginaalravivahend Vaginaalne
Ethinylestradiol/Desogestr el Richter 0.02 mg/0.15mg -28 filmomhulde tabletten 
Ethinylestradiol/Deso gestrel Richter 0.02 mg/0.15mg -28 filmomhulde tabletten