ЭМИЙН ЗӨВЛӨЛИЙН ХУРЛЫН ТЭМДЭГЛЭЛ

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1 ЭМИЙН ЗӨВЛӨЛИЙН ХУРЛЫН ТЭМДЭГЛЭЛ 2017 оны 02-р сарын 23 өдөр Дугаар 2 Улаанбаатар хот Шинээр бүртгэсэн эмийн түүхий эд Эмийн нэр Олон улсын нэршил, найрлага 1. Урсо-мон Урсодеоксихо лийн хүчил Эмийн тун хэмжээ, хэлбэр, үнэ Үйлдвэр-лэгч, үнэ Шийдвэр 100мг 10 капсул Монос фарм ХХК, 2. Флукон-АМ 100мг Флуконазол 100мг 10 капсул Ариун Монгол ХХК 3. Флукон-АМ 150мг Флуконазол 150мг 10 капсул Ариун Монгол ХХК,, Шинээр бүртгэсэн эмийн түүхий эд Эмийн түүхий эдийн нэр Олон улсын нэршил Үйлдвэрлэгч, Улс 1. 60% Sodium lactate 60% Sodium lactate Luoyang Longmen solution solution ceutical БНХАУ 2 Mannitol Mannitol Hebei huaxu ceutical Laboratory БНХАУ 3 Spironolactone Spironolactone Tianjin Jinjin ceutical БНХАУ 4 Cefuroxime sodium Cefuroxime sodium Shandong Luoxin ceutical Group Hengxin ceutical БНХАУ 5 Ketotifen fumarate Ketotifen fumarate Zhejiang ceutical БНХАУ Шийдвэр Шинээр бүртгэсэн уламжлалт эм Эмийн худалдааны Хэлбэр, үнэ Үйлдвэрлэгч Шийдвэр нэршил 1 Чун 9 0,7г 9 талх эм Монг-Эм ХХК, жоргүй 2 Дэгд 4 0,8г 9 тан эм Монг-Эм ХХК, жороор 3 Морэнзогжим 0,7г 9 талх эм Монг-Эм ХХК, жоргүй 4 Гоюу 13 0,7г 9 талх эм Монг-Эм ХХК, жоргүй 5 Болман 7 1г 9 талх эм УАУТХ,

2 жороор 6 Зидарга 6 1г 9 талх эм УАУТХ, жоргүй 7 Лонлүн сэмбрү 13 1г 9 талх эм УАУТХ, жоргүй 8 Бонтаг 9 1г 9 талх эм УАУТХ, жоргүй Шинээр бүртгэсэн импортын эм Худалдааны нэр Олон улсын нэршил /найрлага Тун, хэмжээ, хэлбэр, CIF үнэ Үйлдвэрлэгч, Гарал үүслийн улс, Лиценз эзэмшигч Шийдвэр, Олгох нөхцөл Түргэвчилсэн Б 1 Везомни Солифенацин + Тамсулозин 6mg +0.4mg N10; N30; film coated, bi-layered, modified release ASTELLAS PHARMA TECHNOLOGIES INC, USA ASTELLAS PHARMA EUROPE B.V., THE NETHERLANDS 2 Вильпрафен Джозамицин 500mg N10; film coated DRAGENOPHARM APOTHEKER PUSCHLL GmbH, GERMANY ASTELLAS PHARMA EUROPE B.V., THE NETHERLANDS 3 Финалгон Никобоксил + Нонивамид 4 mg + 25mg - 20g; ointment GLOBOPHARM PHARMAZEUTISCHE PRODUKTIONS UND HANDELSGESELLSCHAF T mbh, AUSTRIA BOEHRINGER INGELHEIM INTERNATIONAL GmbH, GERMANY 4 Галвус Мет Вилдаглиптин + Метформин 50mg + 850mg N60; film coated NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING Pte.Ltd., SINGAPORE NOVARTIS PHARMA SERVICES AG, SWITZERLAND 5 Галвус Мет Вилдаглиптин + Метформин 50mg mg N60; film coated NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING Pte.Ltd., SINGAPORE NOVARTIS PHARMA SERVICES AG, SWITZERLAND

3 6 Лозап Лозартан 7 Торвакард Аторвастатин 8 Торвакард Аторвастатин 9 Торвакард Аторвастатин 50mg N30; film coated 10mg N30; film coated 20mg N30; film coated 40mg N30; film coated 10 Ледибон Тиболон 2.5mg N28; N84 SANECA PHARMACEUTICALS S.A.S, SLOVAK REPUBLIC ZENTIVA A.S., SLOVAK REPUBLIC SANECA PHARMACEUTICALS A.S., SLOVAK REPUBLIC ZENTIVA, A.S., SLOVAK REPUBLIC SANECA PHARMACEUTICALS A.S., SLOVAK REPUBLIC ZENTIVA, A.S., SLOVAK REPUBLIC SANECA PHARMACEUTICALS A.S., SLOVAK REPUBLIC ZENTIVA, A.S., SLOVAK REPUBLIC ZENTIVA K.S., CZECH REPUBLIC 11 Никсар Биластин 20 mg N10; N20; N30; N40; N50; A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L ITALY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A 12 Трилептал Окскарбазепин 300mg N50; film coated NOVARTIS FARMA S.P.A., ITALY, NOVARTIS PHARMA AG 13 Трилептал Окскарбазепин 600mg N50; film coated NOVARTIS FARMA S.P.A., ITALY, NOVARTIS PHARMA AG 16 Долофорте - Денк Трамадолын гидрохлорид + Парацетамол 37.5mg + 325mg N10 х 2; film coated DENK PHARMA GmbH & CO.KG, Germany 17 Денк - Эйр Жуниор 4мг Монтелукаст 4mg N28; chewable DENK PHARMA GmbH & CO.KG, Germany 18 Денк - Эйр Жуниор 5мг Монтелукаст 5mg N28; chewable DENK PHARMA GmbH & CO.KG, Germany 19 Денк - Эйр 10мг Монтелукаст 10mg N28; film coated DENK PHARMA GmbH & CO.KG, Germany

4 20 Лира Цитиколин 100mg/ml - 30ml; oral solution FARMAK, UKRAINE 21 Ботулакс 100 Ботулиний хор А төрөл 100 units N1; lyophilized powder for injection HUGEL INC, REPUBLIC OF KOREA Эмнэлгийн нөхцөлд 22 Неиронокс 50 нэгж Ботулиний хор А төрөл 50 units N1; lyophilized powder for injection MEDYTOX INC, REPUBLIC OF KOREA Эмнэлгийн нөхцөлд 23 Неиронокс 100 нэгж Ботулиний хор А төрөл 100 units N1; lyophilized powder for injection MEDYTOX INC, REPUBLIC OF KOREA Эмнэлгийн нөхцөлд 24 Неиронокс 200 нэгж Ботулиний хор А төрөл 200 units N1; lyophilized powder for injection MEDYTOX INC, REPUBLIC OF KOREA Эмнэлгийн нөхцөлд 28 Мультифлек с пери инж 15 нэрийн амин хүчил + Калийн фосфат + Натрийн ацетат гидрат 1100ml N4; solution for infusion DAI HAN PHARM CO.,LTD, REPUBLIC OF KOREA Аминогекс тарилга Будекорт ингляцийн хөвмөл 14 нэрийн амин хүчил + Д- Сорбитал + Рибофлавины натрийн фосфат + Никотинамид + Витамин В6 + Декспантенол Будесонид 250ml; solution for infusion 0.5mg - 2ml N30; solution for external use DAI HAN PHARM CO.,LTD, REPUBLIC OF KOREA DAI HAN PHARM CO.,LTD, REPUBLIC OF KOREA 31 Комбиалл Эй Ацетаминофен + Хлорфенирамин ий малеат + Метилэфедриний гидрохлорид + Декстрометорфа н + Тиаминий нитрат + Рибофлавин + Аскорбины хүчил 200mg mg mg + 7.5mg + 4mg + 2mg + 15mg N10; SINIL PHARMACEUTICAL Co.,LTD, REPUBLIC OF KOREA 32 Калийн хлорид тарилга Калийн хлорид 150mg/ml - 20ml N50; 150mg/ml - 50ml N50; solution for injection TAIWAN BIOTECH Co.,LTD; TAIWAN

5 33 Бактиром Цефпиром 1g N1; powder for injection PT. SANBE, 34 Эфисол Си Деквалиний хлорид + Аскорбины хүчил 0.25mg + 50mg N20; lozenges PT. NOVELL PHARMACEUTICAL LABORATORIES, 35 Опидиар Каолин + Пектин 986mg + 22mg - 120mg; suspention PT. OTTO PHARMACEUTICAL INDUSTRIES, 36 Предникорт 125 Метилпреднизол он натрийн сукцинат 125mg N1; powder for solution for injection + 2ml solvent PT. PHABROS TBK INDUSTRIES, 37 Гепвин 0.5мг Энтекавир Энгийн эмийн бүртгэл 0.5mg N90; film coated MYLAN LABORATORIES LIMITED, INDIA 38 Гепвин 1мг Энтекавир 1mg N30; film coated MYLAN LABORATORIES LIMITED, INDIA 40 Транлок Транексамын хүчил 500mg N10 x 10; ARISTO LABORATORIES PVT.LTD, INDIA 41 Этамбутол + Изониазид Этамбутол + Изониазид 400mg + 150mg N28 x 24; MACLEODS PHARMACEUTICALS LTD, INDIA 42 Налоксон Налоксон 0.4mg/ml - 1ml N10; solution for injection (FSUE) <<MOSCOW ENDOCRINE PLANT>>, RUSSIAN FEDERATION 43 Ви Рото Лицее Тетрагидрозолин ий гидрохлорид + Цайрын сульфат + Хлорфенирамин ы малеат + Цианокобаламин + Пиридоксины гидрохлорид + Калийн Л - аспартат 13ml N1; eye drops ROHTO-MENTHOLATUM CO., LTD. VIETNAM ROHTO PHARMACEUTICAL CO., LTD.

6 45 Рингер лактатын Натрийн хлорид + Натрийн лактат + Калийн хлорид + Кальцийн хлорид 1.55g + 3g g + 0.1g - 500ml; solution for infusion CISEN ceutical, People's Republic of China 46 Метронидазо л ба натрийн хлоридын Метронидазол + Натрийн хлорид 0.5g + 0.9g ml, solution for infusion CISEN ceutical, People's Republic of China 47 Офлоксацин ба натрийн хлоридын Офлоксацин + Натрийн хлорид 0.2g + 0.9g ml; solution for infusion CISEN ceutical, People's Republic of China 48 Тинидазол ба натрийн хлоридын Тинидазол + Натрийн хлорид 0.4g + 0.9g - 100ml; solution for infusion CISEN ceutical, People's Republic of China 49 Ципрофлокс ацин тарилга Ципрофлоксацин 200mg - 100ml; solution for infusion SHANDONG QIDU PHARMACEUTICAL CO.LTD., People's Republic of China 50 Эстринорм Эстриол ESTRIOL 0.5mg N15; pessaries FARMAPRIM, MOLDOVA 51 Стоп колд Парацетамол + Псевдоэфедрини й гидрохлорид + Хлорфенирамин ий малеат + Гвайфенезин Дахин хэлэлцүүлэх эм 500mg + 30mg + 2mg + 50mg N4 x 15; PT. DARYA VARIA LABORATORIA Tbk, 52 Дегирол 53 Тераваск Деквалиний хлорид Амлодипиний бесилат 0.25mg N4 x 25; lozenges 5mg N30; PT. DARYA VARIA LABORATORIA Tbk, PT. DARYA VARIA LABORATORIA Tbk, 54 Тераваск Амлодипиний бесилат 10mg N30; PT. DARYA VARIA LABORATORIA Tbk,

7 55 Озид Омепразол 20mg N30; capsules PT. DARYA VARIA LABORATORIA Tbk, Энзиплекс ENZYPLEX Ре Би форте RE-B FORTE Витамин В1 + Витамин В2 + Витамин В6 + Витамин В12 + Ниацинамид + Амилаза + Протеаза + Липаза + Кальцийн пантотенат + Дезоксихолийн хүчил + Симетикон Тиамины хлорид + Пиридоксины гидрохлорид + Цианокобаламин THIAMINE MONONITRATE + PYRIDOXINE HYDROCHLORID E + CYANOCOBALA MIN 10mg + 5mg + 5mg + 5mg + 5mcg + 10mg IU IU IU + 5mg + 30mg + 25mg N4 x 25; sugar coated 250mg + 250mg mcg N10 x 10; film coated PT. MEDIFARMA LABORATORIES, UNISON LABORATORIES Co.,LTD, THAILAND ЭМИЙН БҮРТГЭЛИЙН ХУГАЦАА СУНГАЛТ Эмийн худалдааны нэр 1 Дермобактер Олон улсын нэршил Бензалконы хлорид + Хлоргексидин Тун хэмжээ 125мл, 300мл Эмийн хэлбэр Үйлдвэрлэ гч Innothera Chouzy for Innotech International Улс Франц Шийдвэр 2 Кортексин Тугалын тархинаас гарган авсан полипептид 5мг 10 лиофилизат нунтаг Герофарм ОХУ 3 Адваграф Такролимус 5мг 50 уртасгасан үйлдэлтэй капсул Astellas Ireland Ирланд 4 Адваграф Такролимус 0,5мг 50 уртасгасан үйлдэлтэй капсул Astellas Ireland Ирланд 5 Адваграф Такролимус 1мг 50 уртасгасан үйлдэлтэй капсул Astellas Ireland Ирланд 6 Протопик Такролимус 0,1% - 10г тосон түрхлэг Astellas Япон

8 Tech. 7 Протопик Такролимус 0,03% - 10г тосон түрхлэг Astellas Tech. Япон 8 Вүүдс плюс муколитик Бромгексин гидролхорид + Гуайфенезин + Этанол 4мг + 100мг + 6% - 100мл сироп Kalbe International PTE.Ltd 9 Вүүдс плюс антигистами н Декстрометорфа н гидробромид + Дифенгидрамин гидрохлорид 7,5мг мг - 100мл сироп Kalbe International PTE.Ltd 10 Нео- Энтростоп Аттапулгит + Пектин 650мг + 50мг 12 х 2 Kalbe International PTE.Ltd 11 Тенсира Ирбесартан 300мг 30 бүрхүүлтэй PT. Pertiwi Agung 12 Тенсира Ирбесартан 150мг 30 бүрхүүлтэй PT. Pertiwi Agung 13 Опимокс Амоксициллин 1000мг 10 нунтаг PT.Otto pharmaceuti cal Industries 14 Пирален Метоклопрамид 5мг - 2мл 5 PT.Otto pharmaceuti cal Industries 15 Пирален Метоклопрамид 10мг 10 х 10 PT.Otto pharmaceuti cal Industries 16 Ланмер Меропенем 1г 1 нунтаг + солвент PT.Bernofar m, Sidoarjo for PT. Pertiwi Agung 17 Рекуштеин Эрдоштеин 175мг/5мл - 60мл хуурай сироп PT. Pertiwi Agung 18 Левосин Хлорамфеникол + Сульфадиметокс ин + Метилурацил + Тримекаин 40г N1 тосон түрхлэг Нижфарм ОХУ

9 19 Преднизолон Преднизолон 0.5% - 10г тосон түрхлэг Нижфарм ОХУ 20 Метилураци л Метилурацил 10% - 25г тосон түрхлэг Нижфарм ОХУ 21 Синтомицин Хлорамфеникол 250мг 10 үтрээний лаа Нижфарм ОХУ 22 Бензилбензо ат Бензилбензоат 20% - 25гр тосон түрхлэг Нижфарм ОХУ 23 Амлотоп Амлодипин бесилат 5мг 30 Хемофарм ОХУ 24 Амлотоп Амлодипин бесилат 10мг 30 Хемофарм ОХУ 25 Афинитор Эверолимус 10мг 30 Stein AG 26 Афинитор Эверолимус 5мг 30 Stein AG 27 Симулект Басиликсимаб 20мг 1 лиофилизат нунтаг + уусгагч Stein AG 28 Метрогил плюс Метронидазол + Клотримазол 10мг + 20мг - 20г, 30г гель Unique ceuti cal Laboratories Энэтхэг 29 Вольтарен эмульгель Диклофенак 1% - 50г гель Produktions GmbH Герман 30 Вольтарен эмульгель Диклофенак натри 1% - 20г гель Consumer Health SA 31 Синекод Бутамират цитрат 0.15% - 200мл сироп Consumer Health SA 32 Синекод Бутамират цитрат 0.5% - 20мл ууж хэрэглэх дусал Consumer Health SA 33 Прегнон Левоноргестрел 0.75мг 2 JAI PHARMA LTD., Энэтхэг 34 Новонорм Репаглинид 0.5мг 30 Novo- Nordisk A/S Дани

10 35 Новонорм Репаглинид 1мг 30 Novo- Nordisk A/S Дани 36 Новонорм Репаглинид 2мг 30 Novo- Nordisk A/S Дани 37 Сожурн Севофлуран 250мл ингаляци Piramal Critical Care Inc Энэтхэг ЭМИЙН БҮРТГЭЛИЙН ӨӨРЧЛӨЛТ 1 Эмийн худалдааны нэр Натрийн салицилат Олон улсын нэршил Натрийн салицилат Тун хэмжээ 10% - 100мл Эмийн хэлбэр шингэн Үйлдвэрлэг ч Айвико шингэний үйлдвэр Улс Монгол Бүртгэлд оруулахаар шийдвэрлэсэн өөрчлөлт Нэмэлт савалгаа - 2мл 2 Дермобактер 3 Флемоклав солутаб Бензалконы хлорид + Хлоргексидин Амоксициллин + Клавуланы хүчил 125мл, 300мл 875мг + 125мг 14 дисперсийн Innothera Chouzy for Innotech International Astellas Europe B.V. Франц Нидерланд Эмийн бүтээгдэхүүний тодорхойлолт бичиглэлийн өөрчлөлт хийгдсэн Хэрэглэх арга Харилцан үйлчлэл Хөхүүл үед г.м бичиглэл нэмэгдсэн. Түүхий эдийг тоон тодорхойлолтын аргаар шинжилж давхар баталгаажуулдаг болсон. Хэрэглэх зааварт бичиглэлийн өөрчлөлт гарсан 4 Падма 28-60, 200 капсул Padma AG Лиценз эзэмшигч өөрчлөгдсөн -Padma AG-ээс Дэл магнай ХХК болсон. Дэл магнай ХХК нь Padma 28 эмийн чанар аюулгүй байдлыг бүрэн хариуцах болсон. 5 Тонзилмон Одой далан түрүү + Хуурмаг булчирхайт 30 мл цацлага (нунтаг) Монос эмийн үйлдвэр Монгол Нэмэлт савалгаа - 20мл

11 ортууз 6 Виагрос Силденафилий н цитрат 100мг 10 бүрхүүлтэй Монос эмийн үйлдвэр Монгол Нэмэлт савалгаа- 10 савалгааг 4 болгож өөрчилсөн. 7 Низорал Кетоконазол 2% - 15г крем Janssen ceutic a N.V. Бельги дизайны өөрчлөлт 8 Плавикс Клопидогрел 75мг 14, 28 бүрхүүлтэй Sanofi Winthrop Industrie Франц дизайны өөрчлөлт 9 Авелокс Моксифлоксац ин 400мг- 250мл дуслын шингэн Bayer AG Герман дизайны өөрчлөлт 10 Антифлу Ацетаминофен + Фенилэфрин гидрохлорид + Хлорфенирами н малеат 325мг + 5мг + 2мг 12 Contract cal Corp., for Bayer Consumer Care AG, Switzerland АНУ бичиглэлийн өөрчлөлт 11 Бронхикум С Ганганы шингэн ханд 15г - 100мл сироп Nattermann Cie GmbH Герман бичиглэлийн өөрчлөлт 12 Метрогил плюс Метронидазол + Клотримазол 10мг + 20мг - 20г, 10ГР гель Unique ceutic al Laboratories Энэтхэг 50 гр ийн нэмэлт савалгаа 13 Ультрапрокт Цинхокаин + Флюкортолон гр, 30гр тосон түрхлэг Bayer Healthcare Manufacturin g S.r.l Итали бичиглэлийн өөрчлөлт 14 Йодомарин 200 Калийн иодид 200мкг 100, 50 Berlin- Chemie AG /Menarini group/ Герман бичиглэлийн өөрчлөлт

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