Dimethyl fumarate Teva

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-12-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
22-12-2023
Public Assessment Report Public Assessment Report (PAR)
22-12-2023

Active ingredient:

диметил фумарат

Available from:

Teva GmbH

ATC code:

L04AX07

INN (International Name):

dimethyl fumarate

Therapeutic group:

Имуносупресори

Therapeutic area:

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Therapeutic indications:

Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Authorization status:

упълномощен

Authorization date:

2022-12-12

Patient Information leaflet

                                40
Б. ЛИСТОВКА
Лекарствен продукт, който вече не е
разрешен за употреба
41
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
ДИМЕТИЛФУМАРАТ TEVA 120 MG
СТОМАШНО-УСТОЙЧИВИ ТВЪРДИ КАПСУЛИ
ДИМЕТИЛФУМАРАТ TEVA 240 MG
СТОМАШНО-УСТОЙЧИВИ ТВЪРДИ КАПСУЛИ
диметилфумарат (dimethyl fumarate)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ ТОВА
ЛЕКАРСТВО,
ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА ЗА ВАС
ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да се
наложи да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар или
фармацевт.
-
Това лекарство е предписано лично на
Вас. Не го преотстъпвайте на други
хора. То може
да им навреди, независимо че
признаците на тяхното заболяване са
същите като Вашите.
-
Ако получите някакви нежелани
реакции, уведомете Вашия лекар или
фармацевт. Това
включва и всички възможни нежелани
реакции, неописани в тази листовка.
Вижте
точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Диметилфумарат Teva
и за какво се използва
2.
Какво трябва да знаете, преди да
приемете Диметилфумарат Teva
3.
Как да приемате Диметилфумарат Teva
4.
Възможни нежелани реакции
5.
Как да съхранявате Диметилфумарат Teva
6.
Съд
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт, който вече не е
разрешен за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Диметилфумарат Teva 120 mg
стомашно-устойчиви твърди капсули
Диметилфумарат Teva 240 mg
стомашно-устойчиви твърди капсули
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Диметилфумарат Teva 120 mg
стомашно-устойчиви твърди капсули
Всяка стомашно-устойчива твърда
капсула съдържа 120 mg диметилфумарат
(dimethyl fumarate)
Диметилфумарат Teva 240 mg
стомашно-устойчиви твърди капсули
Всяка стомашно-устойчива твърда
капсула съдържа 240 mg диметилфумарат
(dimethyl fumarate)
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Стомашно-устойчива твърда капсула
(стомашно-устойчива капсула)
Диметилфумарат Teva 120 mg
стомашно-устойчиви твърди капсули
Капсули размер 0, приблизително 21,7 mm, с
бяло непрозрачно тяло и синьо
непрозрачно
капаче. Означение „D120“, отпечатано с
черно мастило върху капачето и тялото
.
Диметилфумарат Teva 240 mg
стомашно-устойчиви твърди капсули
Капсули размер 0, приблизително 21,7 mm,
със синьо непрозрачно тяло и синьо
непрозрачно
капаче. Означение „D240“, отпечатано с
черно мастило върху капаче
                                
                                Read the complete document

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Active ingredient диметил фумарат

диметил фумарат

ATC code L04AX07

L04AX07

Marketed by Teva GmbH

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INN (International Name) dimethyl fumarate

dimethyl fumarate

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Patient Information leaflet Patient Information leaflet Spanish 22-12-2023
Summary of Product characteristics Summary of Product characteristics Spanish 22-12-2023
Public Assessment Report Public Assessment Report Spanish 22-12-2023
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Summary of Product characteristics Summary of Product characteristics Czech 22-12-2023
Public Assessment Report Public Assessment Report Czech 22-12-2023
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