Insulin Human Winthrop

Основна информация

  • Търговско наименование:
  • Insulin Human Winthrop
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Insulin Human Winthrop
    Европейски съюз
  • Език:
  • български

Терапевтична информация

  • Терапевтична група:
  • Лекарства, прилагани при диабет,
  • Терапевтична област:
  • Захарен диабет
  • Терапевтични показания:
  • Захарен диабет, при който се изисква лечение с инсулин. Инсулин човешки Winthrop бързо също е подходящ за лечение на hyperglycaemic кома и кетоацидоза, както и за постигане на предварително, интра - и следоперативни стабилизация при пациенти със захарен диабет.
  • Каталог на резюме:
  • Revision: 15

Друга информация

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Отменено
  • Номер на разрешението:
  • EMEA/H/C/000761
  • Дата Оторизация:
  • 17-01-2007
  • EMEA код:
  • EMEA/H/C/000761
  • Последна актуализация:
  • 08-01-2019

Доклад обществена оценка

European Medicines Agency

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged.

EMEA/H/C/761

ЕВРОПЕЙСКИ ДОКЛАД ЗА ОБЩЕСТВЕНА ОЦЕНКА (EPAR)

INSULIN HUMAN WINTHROP RAPID

INSULIN HUMAN WINTHROP BASAL

INSULIN HUMAN WINTHROP COMB (15, 25, 30, 50)

INSULIN HUMAN WINTHROP INFUSAT

Резюме на EPAR за обществено ползване

Настоящият документ представлява резюме на Европейския доклад за обществена

оценка (EPAR). В него се разяснява как Комитетът по лекарствените продукти за

хуманна употреба (CHMP) оценява проведените проучвания, за да направи своите

препоръки как да се използва лекарството.

Ако се нуждаете от повече информация за Вашето медицинско състояние или лечение,

прочетете листовката (също част от EPAR) или попитайте Вашия лекар или

фармацевт. Ако желаете повече информация за основанията на препоръките на CHMP,

прочетете научното обсъждане (също част от EPAR).

Какво представлява Insulin Human Winthrop?

Insulin Human Winthrop е серия от инсулинови разтвори и инжекционни суспенсии. Предлага се

под формата на флакони, патрони или предварително напълнени писалки (OptiSet и SoloStar).

Insulin Human Winthrop съдържа активното вещество човешки инсулин. Продуктовият набор

Insulin Human Winthrop се състои от бързодействащи инсулинови разтвори (Insulin Human

Winthrop Rapid и Insulin Human Winthrop Infusat), съдържащи разтворим инсумин, инсулинова

суспенсия със средна продължителност на действие (Insulin Human Winthrop Basal), съдържаща

изофан инсулин, и комбинация от инсулин с бързо и средно действие в различни пропорции

(Insulin Human Winthrop Comb):

Insulin Human Winthrop Comb 15: 15% разтворим инсулин и 85% кристали инсулин

протамин;

Insulin Human Winthrop Comb 25: 25% разтворим инсулин и 75% кристали инсулин

протамин;

Insulin Human Winthrop Comb 30: 30% разтворим инсулин и 70% кристали инсулин

протамин;

Insulin Human Winthrop Comb 50: 50% разтворим инсулин и 50% кристали инсулин

протамин.

Това лекарство е същото като Insuman, който вече е одобрен в Европейския съюз (ЕС).

Компанията производител на Insuman е дала съгласие нейните научни данни да се използват за

Insulin Human Winthrop.

За какво се използва Insulin Human Winthrop?

Insulin Human Winthrop се използва при пациенти с диабет, които се нуждаят от лечение с

инсулин. Insulin Human Winthrop Rapid е подходящ също за лечение на хипергликемична кома

(кома, която се причинява от много високи нива на кръвната глюкоза [захар]) и кетоацидоза

(високи нива на кетони [киселини] в кръвта), както и за контрол на кръвната глюкоза преди, по

време и след оперативна намеса.

Лекарствен продукт, отпускан по лекарско предписание.

Лекарствен продукт с невалидно разрешение за употреба

Как да използвате Insulin Human Winthrop?

Insulin Human Winthrop се прилага с подкожна инжекция, обикновено в коремната стена

(корема) или бедрото, според препоръките на лекаря. Мястото на инжектиране се променя при

всяка инжекция. Желаните нива на кръвна глюкоза, видът Insulin Human Winthrop, дозата и

времевите интервали се определят от лекаря отделно за всеки пациент и се коригират според

режима на хранене, физическата активност и начина на живот. За да се намери най-ниската

ефективна доза, кръвната глюкоза на пациента трябва да се следи редовно. Insulin Human

Winthrop трябва да се прилага преди хранене. За точно изчисляване на времевите интервали –

вижте листовката.

Insulin Human Winthrop Rapid може да се прилага също венозно, но само в болница, където

състоянието на пациента може да бъде следено непрекъснато. Insulin Human Winthrop Infusat е

специално произведен за лесно прилагане чрез инфузионни помпи.

Как действа Insulin Human Winthrop?

Диабетът е заболяване, при което организмът не произвежда достатъчно инсулин, за да

контролира нивото на кръвната глюкоза. Insulin Human Winthrop е заместващ инсулин, който е

идентичен с инсулина, произвеждан от организма.

Активното вещество в Insulin Human Winthrop, човешки инсулин, се получава по метод, познат

като „рекомбинантна ДНК технология“: от бактерия, получила ген (ДНК), който я прави

способна да произвежда инсулин. Insulin Human Winthrop съдържа инсулин под различни

форми: бързодействащ разтвор (в рамките на 30 минути след инжектирането), изофан и

кристали протамин, които се абсорбират много по-бавно в хода на деня и имат по-

продължително действие.

Заместващият инсулин действа по същия начин като естествено произвеждания инсулин и

помага на глюкозата да навлезе от кръвта в клетките. Чрез контролиране на нивото на кръвната

глюкоза се намаляват симптомите и усложненията на диабета.

Как е проучен Insulin Human Winthrop?

Insulin Human Winthrop е проучен в две изпитвания при 611 пациенти с диабет тип 1 (при който

панкреасът не може да произвежда инсулин) или диабет тип 2 (при който организмът не е в

състояние да използва инсулина ефективно). В едното проучване Insulin Human Winthrop е

използван в инсулинова помпа. В другото Insulin Human Winthrop Comb 25 е сравнен с

полусинтетичен човешки инсулин. В проучванията се измерва нивото на кръвната глюкоза на

гладно (измерено, когато пациентът не е приемал храна в продължение на най-малко осем часа)

или нивата на вещество в кръвта, наречено гликиран хемоглобин (HbA1c), което показва в

каква степен се контролира кръвната глюкоза. Проучванията разглеждат също броя на

пациентите, развили хипогликемия (ниски нива на кръвна глюкоза).

Какви ползи от Insulin Human Winthrop са установени в проучванията?

Insulin Human Winthrop води до намаляване на нивото на HbA1c, което показва, че кръвната

глюкоза се контролира до ниво, сходно с наблюдаваното при употребата на полусинтетичен

човешки инсулин. Insulin Human Winthrop е ефективен, както при диабет тип 1, така и при

диабет тип 2.

Какъв са рисковете, свързани с Insulin Human Winthrop?

Insulin Human Winthrop може да причини хипогликемия. За пълния списък на всички

наблюдавани при Insulin Human Winthrop нежелани реакции – вижте листовката.

Insulin Human Winthrop е противопоказен за хора, които биха могли да проявят

свръхчувствителност (алергични реакции) към човешки инсулин или някоя от другите съставки.

В комбинация с други лекарства, които биха могли да повлияят върху нивата на кръвната

глюкоза, е възможно е да се наложи коригиране на дозите Insulin Human Winthrop. За пълния

списък на тези лекарства – вижте листовката.

Лекарствен продукт с невалидно разрешение за употреба

Основания за одобряване на Insulin Human Winthrop?

Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че ползите от

Insulin Human Winthrop са по-големи от рисковете за лечение на захарен диабет. Комитетът

препоръчва на Insulin Human Winthrop да бъде издадено разрешение за употреба.

Допълнителна информация за Insulin Human Winthrop:

Европейската комисия издава разрешение за употреба, валидно в рамките на ЕС, за Insulin

Human Winthrop на Sanofi-Aventis Deutschland GmbH на 17 януари 2007 г.

Пълният текст на EPAR относно Insulin Human Winthrop може да се намери тук

Дата на последно актуализиране на текста 12-2008.

Лекарствен продукт с невалидно разрешение за употреба

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10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Europe - EMA - European Medicines Agency

4-1-2019


Human medicines: highlights of 2018

Human medicines: highlights of 2018

Human medicines: highlights of 2018

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

17-12-2018


Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, Date of authorisation: 22/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts

Europe - EMA - European Medicines Agency

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

7-12-2018


Human medicines highlights - December 2018

Human medicines highlights - December 2018

Human medicines highlights - December 2018

Europe - EMA - European Medicines Agency

6-12-2018


Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803

Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803

Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803

Europe - EMA - European Medicines Agency

4-12-2018


Meeting summary - EMA Human Scientific’ Committees Working Party with Healthcare Professionals’ Organisations (HCPWP) 26 September 2018

Meeting summary - EMA Human Scientific’ Committees Working Party with Healthcare Professionals’ Organisations (HCPWP) 26 September 2018

Meeting summary - EMA Human Scientific’ Committees Working Party with Healthcare Professionals’ Organisations (HCPWP) 26 September 2018

Europe - EMA - European Medicines Agency

29-11-2018


Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Europe - EMA - European Medicines Agency

29-11-2018


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area:

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area:

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area: , PIP number: P/0212/2018

Europe - EMA - European Medicines Agency

26-11-2018


Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Schizophrenia, Date of authorisation: 26/07/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Schizophrenia, Date of authorisation: 26/07/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Rxulti, brexpiprazole, Schizophrenia, Date of authorisation: 26/07/2018, Status: Authorised

Europe - EMA - European Medicines Agency

26-11-2018


Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 22/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

22-11-2018


Human medicines highlights - November 2018

Human medicines highlights - November 2018

Human medicines highlights - November 2018

Europe - EMA - European Medicines Agency

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2093 (Sanquin Plasma Products B.V.)

EU/3/18/2093 (Sanquin Plasma Products B.V.)

EU/3/18/2093 (Active substance: Human apotransferrin) - Orphan designation - Commission Decision (2018)7803 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/109/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Active substance: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand) - Orphan designation - Commission Decision (2018)7794 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Active substance: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor) - Orphan designation - Commission Decision (2018)7798 of Wed, 21 Nov 2018

Europe -DG Health and Food Safety