Insulin Human Winthrop

Hauptinformation

  • Handelsname:
  • Insulin Human Winthrop
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Insulin Human Winthrop
    Europäische Union
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Medikamente bei diabetes,
  • Therapiebereich:
  • Diabetes Mellitus
  • Anwendungsgebiete:
  • Diabetes mellitus, bei dem eine Behandlung mit Insulin erforderlich ist. Insulin Human Winthrop Rapid eignet sich auch zur Behandlung von hyperglykämischem Koma und Ketoazidose sowie zur prä-, intra- und postoperativen Stabilisierung bei Patienten mit Diabetes mellitus.
  • Produktbesonderheiten:
  • Revision: 15

Weitere Informationen

Status

  • Quelle:
  • EMA - European Medicines Agency
  • Berechtigungsstatus:
  • Zurückgezogen
  • Zulassungsnummer:
  • EMEA/H/C/000761
  • Berechtigungsdatum:
  • 17-01-2007
  • EMEA-Code:
  • EMEA/H/C/000761
  • Letzte Änderung:
  • 08-01-2019

Öffentlichen Beurteilungsberichts

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

EUROPÄISCHER ÖFFENTLICHER BEURTEILUNGSBERICHT (EPAR)

INSULIN HUMAN WINTHROP RAPID

INSULIN HUMAN WINTHROP BASAL

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

INSULIN HUMAN WINTHROP INFUSAT

Zusammenfassung des EPAR für die Öffentlichkeit

Das vorliegende Dokument ist eine Zusammenfassung des Europäischen Öffentlichen

Beurteilungsberichts (EPAR), in dem erläutert wird, wie der Ausschuss für Humanarzneimittel

(CHMP) die durchgeführten Studien beurteilt hat, um zu Empfehlungen bezüglich der Anwendung

des Arzneimittels zu gelangen.

Wenn Sie weitere Informationen über Ihre Krankheit oder deren Behandlung benötigen, lesen Sie

bitte die Packungsbeilage (ebenfalls Bestandteil des EPAR) oder wenden Sie sich an Ihren Arzt

oder Apotheker. Wenn Sie weitere Informationen bezüglich der Grundlage der Empfehlungen des

CHMP wünschen, lesen Sie bitte die wissenschaftliche Diskussion (ebenfalls Bestandteil des

EPAR).

Was ist Insulin Human Winthrop?

Insulin Human Winthrop ist eine Reihe von Insulinlösungen und -suspensionen zur Injektion. Es ist in

Durchstechflaschen, Patronen oder Einweg-Fertigpens (OptiSet und SoloStar) erhältlich.

Insulin Human Winthrop enthält den Wirkstoff Insulin human. Die Insulin Human Winthrop-Reihe

umfasst schnell wirksame Insulinlösungen (Insulin Human Winthrop Rapid und Insulin Human

Winthrop Infusat), die lösliches Insulin enthalten, eine intermediär wirksame Insulinsuspension

(Insulin Human Winthrop Basal), die Isophan-Insulin enthält, und Kombinationen schnell und

intermediär wirksamer Insuline in verschiedenen Anteilen (Insulin Human Winthrop Comb):

Insulin Human Winthrop Comb 15: 15 % lösliches Insulin und 85 % kristallines Protamin-Insulin;

Insulin Human Winthrop Comb 25: 25 % lösliches Insulin und 75 % kristallines Protamin-Insulin;

Insulin Human Winthrop Comb 30: 30 % lösliches Insulin und 70 % kristallines Protamin-Insulin;

Insulin Human Winthrop Comb 50: 50 % lösliches Insulin und 50 % kristallines Protamin-Insulin.

Dieses Arzneimittel ist mit Insuman identisch, das bereits in der Europäischen Union (EU) zugelassen

ist. Der Hersteller von Insuman hat zugestimmt, dass seine wissenschaftlichen Daten für Insulin

Human Winthrop verwendet werden können.

Wofür wird Insulin Human Winthrop angewendet?

Insulin Human Winthrop wird bei Patienten mit Diabetes mellitus angewendet, die eine Behandlung

mit Insulin benötigen.

Insulin Human Winthrop Rapid kann auch zur Behandlung des hyperglykämischen Komas (durch

einen zu hohen Blutzucker (Glukose) verursachtes Koma) und der Ketoazidose (hohe Konzentrationen

von Ketonen (Säuren) im Blut) sowie zur Einstellung des Blutzuckers vor, während oder nach einer

Operation angewendet werden.

Das Arzneimittel ist nur auf ärztliche Verschreibung erhältlich.

Arzneimittel nicht länger zugelassen

Wie wird Insulin Human Winthrop angewendet?

Insulin Human Winthrop wird subkutan (unter die Haut), im allgemeinen in die Bauchwand oder den

Oberschenkel (je nach den Empfehlungen des Arztes), injiziert. Bei jeder Injektion muss eine neue

Einstichstelle gewählt werden. Die angestrebten Blutzuckerspiegel, der Insulin Human Winthrop-Typ,

der zu verwenden ist, sowie die Dosis und Zeitpunkte der Injektionen werden vom Arzt für jeden

Patienten individuell festgelegt und auf Ernährung, körperliche Aktivität und Lebensweise des

Patienten abgestimmt. Der Blutzucker des Patienten sollte regelmäßig gemessen werden, um die

niedrigste wirksame Dosis festzustellen. Insulin Human Winthrop sollte vor einer Mahlzeit

verabreicht werden. Die genauen Zeiten sind der Packungsbeilage zu entnehmen.

Insulin Human Winthrop Rapid kann auch in eine Vene verabreicht werden, jedoch nur im

Krankenhaus, wo der Patient engmaschig überwacht werden kann. Insulin Human Winthrop Infusat ist

eine speziell hergestellte gebrauchsfertige Lösung für Infusionspumpen.

Wie wirkt Insulin Human Winthrop?

Diabetes ist eine Krankheit, bei der der Körper nicht genügend Insulin zur Regelung des

Blutzuckerspiegels (Glukosespiegels) produziert. Insulin Human Winthrop ist ein Ersatzinsulin, das

mit dem vom Körper gebildeten Insulin identisch ist.

Der Wirkstoff in Insulin Human Winthrop, Insulin human, wird nach einer Methode hergestellt, die

als „rekombinante DNA-Technologie“ bezeichnet wird. Er wird von einem Bakterium produziert, in

das ein Gen (DNA) eingebracht wurde, das es zur Bildung von Insulin befähigt. Insulin Human

Winthrop enthält Insulin in verschiedenen Formen: die lösliche Form, die rasch wirkt (innerhalb von

30 Minuten nach der Injektion), sowie die „Isophan“- und die kristalline Protaminform, die sehr viel

langsamer im Verlauf des Tages resorbiert werden und somit eine längere Wirkdauer haben.

Das Ersatzinsulin wirkt in gleicher Weise wie natürlich produziertes Insulin und trägt dazu bei, dass

Glukose aus dem Blut in die Zellen aufgenommen wird. Durch Einstellung des Blutzuckers werden

die Symptome und Komplikationen von Diabetes verringert.

Wie wurde Insulin Human Winthrop untersucht?

Insulin Human Winthrop wurde in zwei Studien bei 611 Patienten mit Typ-1-Diabetes, bei dem die

der Körper kein Insulin produzieren kann, oder mit Typ-2-Diabetes, bei dem der Körper nicht in der

Lage ist, das Insulin wirksam zu nutzen, untersucht. In einer dieser Studien wurde Insulin Human

Winthrop in einer Insulinpumpe angewendet. In der anderen Studie wurde Insulin Human Winthrop

Comb 25 mit halbsynthetischem Humaninsulin verglichen. In den Studien wurden die

Konzentrationen des Nüchternblutzuckers (vor der Blutentnahme mindestens acht Stunden keine

Nahrungsaufnahme) bzw. einer Substanz (glykosyliertes Hämoglobin, HbA1c) im Blut gemessen, die

anzeigt, wie gut der Blutzucker eingestellt ist. Außerdem wurde in den Studien die Zahl der Patienten

untersucht, bei denen eine Hypoglykämie (Unterzuckerung) auftrat.

Welchen Nutzen hat Insulin Human Winthrop in diesen Studien gezeigt?

Insulin Human Winthrop führte zu einer Abnahme des HbA1c-Spiegels, die darauf hindeutete, dass

die Blutzuckerspiegel auf ein ähnliches Niveau wie mit halbsynthetischem Humaninsulin eingestellt

worden waren. Insulin Human Winthrop war sowohl bei Typ-1- als auch bei Typ-2-Diabetes wirksam.

Welches Risiko ist mit Insulin Human Winthrop verbunden?

Insulin Human Winthrop kann Hypoglykämie (Unterzuckerung) verursachen. Die vollständige

Auflistung der im Zusammenhang mit Insulin Human Winthrop berichteten Nebenwirkungen ist der

Packungsbeilage zu entnehmen.

Insulin Human Winthrop darf nicht bei Patienten angewendet werden, die möglicherweise

überempfindlich (allergisch) gegen Insulin human oder einen der sonstigen Bestandteile sind.

Außerdem müssen die Dosen von Insulin Human Winthrop möglicherweise angepasst werden, wenn

es zusammen mit anderen Arzneimitteln verabreicht wird, die sich auf den Blutzuckerspiegel

auswirken können. Die vollständige Auflistung dieser Arzneimittel ist der Packungsbeilage zu

entnehmen.

Warum wurde Insulin Human Winthrop zugelassen?

Der Ausschuss für Humanarzneimittel (CHMP) gelangte zu dem Schluss, dass die Vorteile von

Insulin Human Winthrop bei der Behandlung des Diabetes mellitus gegenüber den Risiken

Arzneimittel nicht länger zugelassen

überwiegen, und empfahl, die Genehmigung für das Inverkehrbringen von Insulin Human Winthrop

zu erteilen.

Weitere Informationen über Insulin Human Winthrop:

Am 17. Januar 2007 erteilte die Europäische Kommission dem Unternehmen Sanofi-Aventis

Deutschland GmbH eine Genehmigung für das Inverkehrbringen von Insulin Human Winthrop in der

gesamten Europäischen Union.

Den vollständigen Wortlaut des EPAR für Insulin Human Winthrop finden Sie hier

Diese Zusammenfassung wurde zuletzt im 12-2008 aktualisiert.

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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