natgillin/translations-raw huggingface dataset:
СПИСЪК НА ИМЕНАТА, ЛЕКАРСТВЕНА ФОРМА, КОЛИЧЕСТВО НА АКТИВНОТО ВЕЩЕСТВО
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
0,1 mg е по-ниска от наблюдаваната при комбинацията Е2 1 mg/NETA 0,1 mg, все още не е недвусмислено доказано, че тя ще бъде в приемливи граници според европейските насоки.
However, some CHMP members considered that even if the observed hyperplasia incidence with the new dose E2 0.5 mg/NETA 0.1 mg should be lower than that observed with the E2 1mg/NETA 0.1mg combination, it is not unequivocally demonstrated that it will be in an acceptable range regarding the European guideline.
През първите месеци на лечението може да се наблюдава пробивно кръвотечение и зацапване.
Breakthrough bleeding and spotting may occur during the first months of treatment.
Неразположение
Lactation
Доброкачествени и злокачествени неоплазми (вкл. кисти и полипи): рак на ендометриума
cysts and polyps): Endometrial cancer
Латвия - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Литва - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Люксембург - Activelle minor comprimés pelliculés Холандия - Activelle filmomhulde tabletten
Iceland - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Ireland - Activelle low 0.5mg/0.1mg film-coated tablets Italy - Activelle® 0,5 mg/0,1 mg compresse film-rivestite Latvia - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Lithuania - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Luxembourg - Activelle minor comprimés pelliculés The Netherlands - Activelle filmomhulde tabletten Norway - Noviana 0,5 mg/0,1 mg tablett filmdrasjert Portugal - 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película Romania - Noviana comprimate filmate
Мигрена Замаяност
Migraine Dizziness
Общи нарушения и такива според мястото на приложение
General disorders and administration site conditions
Диспепсия
Dyspepsia
Пушене
• Smoking
Ако някоя от нежеланите лекарствени реакции стане сериозна или забележите други,
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Всяка таблетка съдържа естрадиол 0,5 mg (като хемихидрат) и норетистеронов ацетат 0,1 mg.
Each tablet contains 0.5 mg estradiol (as hemihydrate) and 0.1 mg norethisterone acetate.
Всяка филмирана таблетка съдържа:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains:
Activelle (Активел) и свързани с него имена (вижте Приложение І) 0,5 mg/0,1 mg филмирани таблетки [Вижте Приложение
Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I - To be completed nationally]
Activelle (Активел) и свързани с него имена (вж.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ACTIVELLE AND ASSOCIATED NAMES (SEE ANNEX I)
0,1 mg comprimidos recubiertos de película
Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película
Нарушения на кожата и подкожната тъкан: себорея, кожен обрив, ангионевротичен оток
• Skin and subcutaneous tissue disorder: Seborrhoea, rash, angioneurotic oedema
Чехия - Noviana potahované tablety Дания - Activelle low filmovertrukne tabletter Естония - Activelle low
Denmark - Activelle low filmovertrukne tabletter
Да се съхранява на място, недостъпно за деца
Keep out of the reach and sight of children
0,5 mg (като хемихидрат) и норетистеронов ацетат (norеthisterone acetate) 0,1 mg.
Estradiol 0.5 mg (as hemihydrate) and norethisterone acetate 0.1 mg.
ПАРТИДЕН НОМЕР Партида:
BATCH NUMBER Batch
Не е известно дали това се отнася за по-млади жени и за жени, приемащи други продукти за ХЗТ.
It is not known whether these results also applies to women younger than 65 years when starting the treatment or to women taking other HRT preparations.
ДА СЪХРАНЯВАТЕ АКТИВЕЛ
HOW TO STORE ACTIVELLE
Годен до:
et al.:
Остаряване
• Getting older
Всяка филмирана таблетка съдържа: естрадиол 0,5 mg (като хемихидрат), норетистеронов ацетат 0,1 mg
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: estradiol 0.5 mg (as hemihydrate), norethisterone acetate 0.1 mg
Нарушения на репродуктивните органи и гърдите: хиперплазия на еднометриума,
• Reproductive system and breast disorders: Hyperplasia endometrial, vulvovaginal pruritus
Коремна болка Гадене
Breast pain Breast discomfort
Естрадиол (Еstradiol)
• Heartburn (dyspepsia)
Инсулт
Stroke
Ако сте имала спонтанен аборт
• If you have had a miscarriage
Неравномерно биене на сърцето.
• An irregular heartbeat.
Хидроксипропилцелулоза Талк
Lactose monohydrate Maize starch Hydroxypropylcellulose Talc
Болка или напрежение в гърдите
• Breast pain or breast discomfort
ОСНОВАНИЯ
GROUNDS
Спазми на мускулите на краката
Effects on the skin
Няколко епидемиологични проучвания докладват общ повишен риск от рак на гърдата за естроген-прогестаген комбинирана ХЗТ в сравнение със самостоятелната естрогенова терапия.
For oestrogen plus progestagen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with oestrogens alone.
Белгия - Activelle minor comprimés pelliculés България - Noviana™ филмирани таблетки
Bulgaria - Noviana™ филмирани таблетки
Честотата на възможните нежелани реакции, описани по-долу, е определена по следния начин:
The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Замаяност
Nausea
ПО ЛЕКАРСТВАТА (EMEA)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
• Вагинално кръвотечение.
Very common side effects • Vaginal bleeding.
Ако след три месеца повлияването на симптомите е незадоволително, може да се мисли за преминаване към по-високо дозиран продукт, например Activelle 1 mg/0,5 mg.
A switch to a higher dose product, e.g. Activelle 1 mg/0.5 mg tablets, should be considered if the response after three months is insufficient for satisfactory symptom relief.
0,5 mg + Норетистеронов ацетат 0,1 mg
Estradiol (as hemihydrate) 0.5 mg + Norethisterone acetate 0.1 mg
НАЧИН НА ОТПУСКАНЕ [Да се попълни съгласно националните изисквания]
GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
аденом на черния дроб)
(endometrial cancer)
(засягат от 1 до 10 на 1 000 жени)
Uncommon (affects 1 to 10 users in 1,000)
Косопад
Batch
Спрете приема на ХЗТ, докато
Stop taking HRT until your doctor says you can.
2614-504 Amadora
2614-504 Amadora Portugal
Финландия Orion Corporation Orionintie 1/A
Czech Republic Orion Corporation Orionintie 1/A
TEVA PHARMA BELGIUM NV Laarstraat 16
Belgium TEVA PHARMA BELGIUM NV Laarstraat 16
Португалия Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa
Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal
Parque Empresarial San Fernando, San Fernando de Henares (Madrid).28830. SPAIN
Parque Empresarial San Fernando, San Fernando de Henares (Madrid).28830.
1070-274 Lisboa
1070-274 Lisboa Portugal
Списък на имената, лекарствените форми, количество на активното вещество в дозова единица на лекарствените продукти, пътища на въвеждане, притежатели на разрешенията за употреба в държавите членки
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Португалия Aurobindo Pharma (Portugal), Unipessoal Lda.
Aurobindo Pharma (Portugal), Unipessoal Lda.
Швеция sanofi-aventis AB Box 14142
Sweden sanofi-aventis AB Box 14142
GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN
Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN
Португалия Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Латвия sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
2794-038 Carnaxide
2794-038 Carnaxide Portugal
Krka d.d. Novo Mesto Smarjeska cesta 6.
Novo Mesto Smarjeska cesta 6.
LABORATORIO STADA, S.L. Frederic Mompou, 5 , Sant Just Desvern (Barcelona).
Frederic Mompou, 5 , Sant Just Desvern (Barcelona).
Дания sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Португалия Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Laboratórios Azevedos - Indústria Farmacêutica, S.A.
Холандия ratiopharm Nederland B.V. Swensweg 5
The Netherlands ratiopharm Nederland B.V. Swensweg 5
Triados 36, Palaio Faliro 17562
Areos 103 and Ag. Triados 36, Palaio Faliro 17562
Люксембург MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Luxembourg MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Австрия ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Austria ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Австрия sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
Austria sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda.
BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor.
Португалия Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom
Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom
Sanofi Malta Ltd. St.
Sanofi Malta Ltd. St. Julian's Rd.
Португалия Meda Pharma - Produtos Farmacêuticos, S.A.
Meda Pharma - Produtos Farmacêuticos, S.A.
Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland
Marszałka J. Piłsudskiego 5 95-200 Pabianice
Люксембург Eurogenerics S.A. Esplanade Heysel, b22
Luxembourg Eurogenerics S.A. Esplanade Heysel, b22
João II, Lote 1.06.2.2 C - 7.3 e 7.4
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C7.3 e 7.4
Люксембург MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Luxembourg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
ZI de Courtaboeuf 91140 Villebon Sur Yvette France
LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette France
Esplanade Heysel, b22 1020 Bruxelles Belgium
Eurogenerics S.A. Esplanade Heysel, b22 1020 Bruxelles Belgium
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Люксембург SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Luxembourg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Люксембург Genthon BV Microweg, 22
Luxembourg Genthon BV Microweg, 22
Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Belgium MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
LABORATORIOS CINFA, S.A. OlazChipi, 10. Poligono Industrial Areta .Huarte-Pamplona (Navarra)
Poligono Industrial Areta .Huarte-Pamplona (Navarra)
MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Farma-Projekt Sp. z o.o. ul. Józefińska 2
Farma-Projekt Sp. z o.o.
Telecom Gardens Medialaan 40
Belgium SANDOZ N.V. Telecom Gardens Medialaan 40
Португалия Sanofi - Produtos Farmacêuticos, Lda.
Sanofi - Produtos Farmacêuticos, Lda.
Чешка република sanofi-aventis, s.r.o.
Czech Republic sanofi-aventis, s.r.o.
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom
Teva Italia S.r.l. - via Messina 3820154 Milano Italy
- via Messina 3820154 Milano Italy
Португалия Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2ºEscritório 15
Alameda da Beloura, Edifício 1, 2ºEscritório 15
Люксембург Apotex Europe B.V. Darwinweg 20
Luxembourg Apotex Europe B.V. Darwinweg 20
Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º Planta , Barcelona.
Plom 2-4, 5º Planta , Barcelona.
92931 Paris La Défense Cedex FRANCE
110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE
Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany
Takeda GmbH 2 Byk-Gulden Strasse 78467 Konstanz Germany
TEVA GENERICOS ESPAÑOLA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid).
C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid).
Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd.
Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303
Португалия Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark
Empreendimento Lagoas Park Edifício 7, 3º Piso
Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal
Lagoas Park, Edifício 5 A, Piso 2
Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal
Zolpidem Sanofi-Aventis Belgium
Zolpidem Sanofi-Aventis Belgium 10 mg
Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703
Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main Germany
Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten ефервесцентна таблетка
Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten effervescent tablet oral use
Финландия Sanofi Oy Huopalahdentie 24
Sanofi Oy Huopalahdentie 24 P.O.Box 22
Финландия Vitabalans Oy Varastokatu 8
Czech Republic Vitabalans Oy Varastokatu 8
Godfried Bomansstraat 31 6543
Godfried Bomansstraat 31 6543 JA NIJMEGEN The Netherlands
02130 Espoo Finland
Meda Oy Vaisalantie 4 02130 Espoo Finland
UAB „SANOFI-AVENTIS LIETUVA“ A.
UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g.
ZENTIVA ITALIA S.R.L. - Viale Bodio 37/b, 20158 Milano Italy
- Viale Bodio 37/b, 20158 Milano Italy
ZOLPIDEM-RATIOPHARM 10 MG
ZOLPIDEM-RATIOPHARM 10 MG 10 mg
Словакия sanofi-aventis Slovakia s.r.o. Einsteinova 24
Slovak Republic sanofi-aventis Slovakia s.r.o.
Zolpidem Genthion обвита таблетка перорално приложение
Zolpidem Genthion coated tablet oral use
Sandoz GmbH ul. Biochemiestrasse 10 Kundli
Biochemiestrasse 10 Kundli
Финландия ratiopharm GmbH Graf Arco Strasse 3
Czech Republic ratiopharm GmbH Graf Arco Strasse 3
Doc Generici S.r.l. Turati 40, Milano - 20121 Italy
Turati 40, Milano - 20121 Italy
Stilnoct, tabletten 10 mg таблетка
Stilnoct, tabletten 10 mg tablet oral use
ADORMA 5 mg filmom obalené tablety
ADORMA 5 mg filmom obalené tablety 5 mg
Stilnoct 5mg fiilm-coated tablets обвита таблетка перорално приложение
Stilnoct 5mg fiilm-coated tablets coated tablet oral use
ExtractumPharma zRt. Megyeri út 64.
ExtractumPharma zRt.
Perluna 5 mg filmsko obožene tablete
Perluna 5 mg filmsko obožene tablete 5 mg
SANDOZ s.r.o.
Czech Republic SANDOZ s.r.o.
Takeda GmbH 2 Byk-Gulden Strasse
Czech Republic Takeda GmbH Byk-Gulden-Str. 2
Josep Plá, 2, Barcelona.
SANOFI AVENTIS, S.A. Josep Plá, 2, Barcelona.
Dodorest обвита таблетка перорално приложение
Dodorest coated tablet oral use
Zolpidem Sandoz 10 mg filmcoated tablets
Zolpidem Sandoz 10 mg film-coated tablets
Sanval 10 mg filmsko obožene tablete
Sanval 10 mg filmsko obožene tablete 10 mg
Германия neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str.
Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
1749-066 Lisboa
Rua do Centro Cultural, 13 1749-066 Lisboa Portugal
Lunata 5 mg filmom obložene tablete
Lunata 5 mg filmom obložene tablete 5 mg
Португалия Generis Farmacêutica, S.A. Rua João de Deus, 19
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal
Nytamel 5 mg Film-coated Tablets
Nytamel 5 mg Film-coated Tablets 5 mg
Mondeal 10 mg - Filmtabletten 10 mg
Mondeal 10 mg - Filmtabletten
Sanval 10 mg filmom obložene tablete
Sanval 10 mg filmom obložene tablete 10 mg
Stilnoct 10mg film-coated tablets обвита таблетка перорално приложение
Stilnoct 10mg film-coated tablets coated tablet oral use
Viale Fulvio 330 20126 Milano Italy
Italfarmaco S.p.A. Viale Fulvio 330 20126 Milano Italy
Viale Fulvio Testi 330, 20126 Milano, Italy
ITALFARMACO S.p.A. Viale Fulvio Testi 330, 20126 Milano, Italy
Zolpidem Tartrate 10mg tablets 10 mg
Zolpidem Tartrate 10mg tablets
Stilnoct обвита таблетка перорално приложение
Stilnoct tablet oral use
10 mg/ml перорални капки,разтвор
10 mg/ml oral drops, solution oral use
Sanval 5 mg filmom obložene tablete
Sanval 5 mg filmom obložene tablete 5 mg
Zolpidem Tartrate 5mg tablets 5 mg
Zolpidem Tartrate 5mg tablets
Zolpidem Aristo 10 mg Filmtabletten
Zolpidem Aristo 10 mg Filmtabletten 10 mg
Zolpidem real 10 mg Filmtabletten
Zolpidem real 10 mg Filmtabletten 10 mg
Sanval 5 mg filmsko obložene tablete
Sanval 5 mg filmsko obložene tablete 5 mg
Zolpidem AbZ 10 mg Filmtabletten
Zolpidem AbZ 10 mg Filmtabletten 10 mg
Zolpidem Cinfa 10 mg Comprimidos
Zolpidem Cinfa 10 mg Comprimidos 10 mg
HYPNOGEN 10 mg filmtabletta 10 mg
Hypnogen 10 mg film-coated tablets 10 mg
Lunata 10 mg filmom obložene tablete
Lunata 10 mg filmom obložene tablete 10 mg
Zolsana 5 mg coated tablets 5 mg обвита таблетка перорално приложение
Zolsana 5 mg coated tablets coated tablet oral use
STILNOX 10 mg filmtabletta 10 mg
STILNOX 10 mg filmtabletta
EDLUAR 5 mg nyelvalatti tabletta сублингвална таблетка сублингвално приложение
EDLUAR 5 mg nyelvalatti tabletta sublingual tablet sublingual use
Zolpitop обвита таблетка перорално приложение
Zolpitop coated tablet oral use
Zolpidem Vitabalans 10 mg film-coated tablets
Zolpidem Vitabalans 10 mg filmcoated tablets
Edluar 10 mg, tablet voor sublinguaal gebruik сублингвална таблетка сублингвално приложение
Edluar 10 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Португалия Genthon GmbH Groesbeeker Weg, 1
Genthon GmbH Groesbeeker Weg, 1 D-47559 Kranenburg Germany
Zoldem 5 mg - Filmtabletten 5 mg
Zoldem 5 mg - Filmtabletten
Zolpidem Tartrate 10mg, filmcoated tablets
Zolpidem Tartrate 10mg, film-coated tablets
Zolsana 10 mg coated tablets 10 mg обвита таблетка перорално приложение
Zolsana 10 mg coated tablets coated tablet oral use
Edluar 5 mg, tablet voor sublinguaal gebruik сублингвална таблетка сублингвално приложение
Edluar 5 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Zolpidem Hexal 10 mg Filmtabletten
Zolpidem Hexal 10 mg Filmtabletten 10 mg
Zolpidem Tartrate 5mg, filmcoated tablets
Zolpidem Tartrate 5mg, film-coated tablets
Zolpidemtartraat ADOH 10 mg, bruistabletten ефервесцентна таблетка
Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten effervescent tablet oral use
Zolpidem Sandoz 10 mg Filmtabletten
Zolpidem Sandoz 10 mg Filmtabletten 10 mg
Zolpidemtartaat Actavis 5 mg, tabletten таблетка
Zolpidemtartaat Actavis 5 mg, tabletten tablet oral use
Zolpidem Tartrate Teva 10 mg Film-coated Tablets
Zolpidem Tartrate Teva 10 mg Filmcoated Tablets
SOMNOGEN 10 mg filmtabletta 10 mg
SOMNOGEN 10 mg filmtabletta
Zolpidem IPCA 5 mg Filmtabletten
Zolpidem IPCA 5 mg Filmtabletten 5 mg
Zolpi-Q 10 mg Filmtabletten 10 mg
Zolpidem-CT 10 mg Filmtabletten 10 mg
Zolpidem Tartrate Teva 5 mg Film-coated Tablets
Zolpidem Tartrate Teva 5 mg Filmcoated Tablets
Zolpidemtartraat CF 10 mg, film-omhulde tabletten
Zolpidemtartraat CF 10 mg, filmomhulde tabletten
Zolpidem Tartrate 5mg filmcoated tablets
Zolpidem Tartrate 5mg film-coated tablets
Zolpidem Tartrate 10mg filmcoated tablets
Zolpidem Tartrate 10mg film-coated tablets
Zolpidem-Actavis 10 mg Filmtabletten
Zolpidem-Actavis 10 mg Filmtabletten 10 mg
Zolpidem STADA 5 mg Filmtabletten
Zolpidem STADA 5 mg Filmtabletten 5 mg
SANOFI-AVENTIS ROMÂNIA S.R.L. Str. Izvor, Nr. 80, Et.
SANOFI-AVENTIS ROMÂNIA S.R.L.
Zolpidem dura 10 mg Filmtabletten
Zolpidem dura 10 mg Filmtabletten 10 mg
Zolpidem IPCA 10 mg Filmtabletten
Zolpidem IPCA 10 mg Filmtabletten 10 mg
Zolpidemtartraat Actavis 10 mg, tabletten таблетка
Zolpidemtartraat Actavis 10 mg, tabletten tablet oral use
Zoldem 10 mg - Filmtabletten 10 mg
Zoldem 10 mg - Filmtabletten
PIDEZOL 10 mg filmtabletta 10 mg
PIDEZOL 10 mg filmtabletta
Zolpidem STADA 10 mg Filmtabletten
Zolpidem STADA 10 mg Filmtabletten 10 mg
ZOLSANA 10 mg filmtabletta 10 mg
Zolpidem AL 10 mg Filmtabletten 10 mg
Zolpidemtartraat ratiopharm 5 mg, tabletten таблетка
Zolpidemtartraat ratiopharm 5 mg, tabletten tablet oral use
Zolpidem-CT 10 mg Filmtabletten
Zolpi-Q 10 mg Filmtabletten
Швеция ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Zolpeduar сублингвална таблетка сублингвално приложение
Zolpeduar sublingual tablet oral use
Edluar 10 mg sublingual tablets 10 mg сублингвална таблетка сублингвално приложение
EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use
Обединеното кралство ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
United Kingdom ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Германия ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Edluar 10 mg Sublingualtabletten сублингвална таблетка сублингвално приложение
Edluar 10 mg podjezične tablete sublingual tablet sublingual use
Zolpidemtartraat ratiopharm 10 mg, tabletten таблетка
Zolpidemtartraat ratiopharm 10 mg, tabletten tablet oral use
Zolsana 5 mg filmom obložene tablete
Zolsana 5 mg filmom obložene tablete 5 mg
Edluar 10mg sublingual tablets 10 mg сублингвална таблетка
Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use
ZOLSANA 5 mg filmtabletta 5 mg
Zolsana 5 mg filmsko obložene tablete 5 mg
Edluar 5 mg Sublingualtabletten сублингвална таблетка сублингвално приложение
Edluar 5 mg podjezične tablete sublingual tablet sublingual use
Stilnoct таблетка
tablet oral use
Zolpidem 10mg film-coated tablets
Zolpidem 10mg film-coated tablets 10 mg
Edluar 5mg sublingual tablets 5 mg сублингвална таблетка
Edluar 5mg sublingual tablets sublingual tablet oral use
ZOLPIDEM SANDOZ 10 MG 10 mg таблетка
ZOLPIDEM SANDOZ 10 MG
Zolpi-Lich 10 mg Filmtabletten 10 mg
Zolpi-Lich 10 mg Filmtabletten
Приключване на процедура по член 29 на Директива 2001/83/ЕО, както е изменена
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
разрешението за употреба да бъде признато в България, Германия, Франция, Ирландия и Италия („засегнатите държави-членки“).
The company wanted the authorisation to be recognised in Bulgaria, Germany, France, Ireland and Italy (the ‘concerned Member States').
Европейската комисия публикува решение на 5 октомври 2010 г.
The European Commission issued a decision on 5 October 2010.
Daniela Melchiorri (Италия)
Daniela Melchiorri (Italy)
Kristina Dunder (Швеция)
Kristina Dunder (Sweden)
Въпреки това държавите-членки не са в състояние да постигнат съгласие и Шведската регулаторна агенция по лекарствата отнася въпроса към СНМР за арбитраж на 29 април 2010 г.
However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.
Блокирането на действието на тези клетки води до по-малка загуба на костно вещество.
Blocking the action of these cells leads to less bone loss.