Human Albumin "Octapharma"

Hauptinformation

  • Handelsname:
  • Human Albumin "Octapharma" 25 % - Infusionsflasche
  • Einheiten im Paket:
  • 50 ml, Laufzeit: 36 Monate,100 ml, Laufzeit: 36 Monate
  • Verschreibungstyp:
  • Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Human Albumin "Octapharma" 25 % - Infusionsflasche
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Blood substitutes and pla
  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 2-00276
  • Berechtigungsdatum:
  • 19-09-2002
  • Letzte Änderung:
  • 07-03-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Seite 1/7

GEBRAUCHSINFORMATION: INFORMATION FÜR DEN ANWENDER

HUMAN ALBUMIN „OCTAPHARMA“ 25 %-INFUSIONSFLASCHE

Wirkstoff: Humanalbumin aus menschlichem Plasma

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der

Anwendung dieses Arzneimittels beginnen, denn sie enthält wichtige

Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals

lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an

Dritte weiter. Es kann anderen Menschen schaden, auch wenn diese die gleichen

Beschwerden haben wie Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder

Apotheker. Dies gilt auch für Nebenwirkungen, die nicht in dieser Packungsbeilage

angegeben sind. Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht

1. Was ist Human Albumin „Octapharma“ 25 % - Infusionsflasche und wofür wird es

angewendet?

2. Was sollten Sie vor der Anwendung von Human Albumin „Octapharma“ 25 % -

Infusionsflasche beachten?

3. Wie ist Human Albumin „Octapharma“ 25 % - Infusionsflasche anzuwenden?

4. Welche Nebenwirkungen sind möglich?

5. Wie ist Human Albumin „Octapharma“ 25 % - Infusionsflasche aufzubewahren?

6. Inhalt der Packgung und weitere Informationen

1.

Was ist Human Albumin „Octapharma“ 25 % - Infusionsflasche und wofür

wird es angewendet?

Human

Albumin

"Octapharma"

Infusionsflasche

gehört

pharmako-

therapeutischen Gruppe der Plasmasubstitute und Plasmaproteinfraktionen. Das

Produkt

wird

Patienten

verabreicht,

zirkulierende

Blutvolumen

wieder

herzustellen bzw. zu erhalten, wenn ein Mangel an Volumen festgestellt wurde.

Seite 2/7

2.

Was müssen Sie vor der Anwendung von Human Albumin „Octapharma“

25 % - Infusionsflasche beachten?

Human Albumin „Octapharma“ 25 % - Infusionsflasche darf nicht angewendet

werden,

wenn

eine

Überempfindlichkeit

gegen

Albuminpräparate

oder

einen

anderen Inhaltsstoffe des Produktes haben.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Human Albumin

„Octapharma“ 25 % - Infusionsflasche anwenden.

Besondere Vorsicht bei der Anwendung von Human Albumin „Octapharma“ 25 % -

Infusionsflasche ist erforderlich,

Falls Sie auf diese Albuminbehandlung allergisch reagieren, wird die Infusion

abgebrochen und Ihr Arzt wird Ihnen eine alternative Behandlung vorschlagen.

wenn Sie ein erhöhtes Risiko eines hohen Blutvolumens haben, z.B. bei einigen

Herzkrankheiten, oder an hohem Blutdruck, Erweiterung der Speiseröhrenvenen

Flüssigkeit in der Lunge, Gerinnungsstörungen, verminderter Anzahl an roten

Blutkörperchen oder eingeschränkter Harnproduktion leiden.

bei Anzeichen eines erhöhten Blutvolumens (Kopfschmerzen, Atembeschwerden,

Blutstauung in den Halsvenen) oder erhöhtem Blutdruck. Die Infusion sollte sofort

abgebrochen werden.

Dieses Produkt enthält Natrium und Kalium und könnte für Personen mit einer

natrium- bzw. kaliumarmen Diät schädlich sein. Bitte informieren Sie Ihren Arzt,

falls dies auf Sie zutrifft.

Wenn konzentriertes Albumin verabreicht wird, ist besondere Vorsicht geboten, um

eine

ausgeglichene

Flüssigkeitsbilanz

Patienten

sicherzustellen.

Patienten

sollten

sorgfältig

überwacht

werden,

Kreislaufüberlastung

durch

einen

Flüssigkeitsüberschuss zu vermeiden.

Darüber

hinaus

sollten

Elektrolytwerte

Patienten

überwacht

entsprechende

Maßnahmen

gesetzt

werden,

Elektrolytgleichgewicht

wiederherzustellen bzw. zu erhalten.

Albuminlösungen dürfen nicht mit Wasser für Injektionszwecke verdünnt werden, da

dies zu Veränderungen im Blutbild beim Patienten führen kann.

Wenn

relativ

große

Mengen

Albumin

verabreicht

werden

sollen,

eine

Überwachung der Gerinnung und des Hämatokrit erforderlich. Sorgfalt ist geboten,

eine

ausreichende

Versorgung

anderen

Blutbestandteilen

(Gerinnungsfaktoren,

Elektrolyte,

Blutplättchen

rote

Blutkörperchen)

sicherzustellen.

erhöhtes

zirkulierendes

Blutvolumen

kann

auftreten,

wenn

Dosis

Infusionsgeschwindigkeit nicht an die Kreislaufsituation des Patienten angepasst

werden.

ersten

Anzeichen

einer

Überlastung

Gefäßsystems

Herzens (Kopfschmerzen, Atemnot, Halsvenen-Stauung), eines erhöhten Blutdrucks

Seite 3/7

oder eines erhöhten Venendrucks und eines Lungenödems muss die Infusion sofort

abgesetzt werden.

Standardmaßnahmen

Verhinderung

Infektionen

infolge

Verwendung von aus menschlichem Blut oder Plasma hergestellten Arzneimitteln

zählen

Auswahl

Spender,

Untersuchung

einzelnen

Spenden

Plasmapools auf spezifische Infektionsmarker sowie wirksame Produktionsschritte

zur Inaktivierung/Entfernung von Viren. Dennoch kann bei der Verabreichung von

Arzneimitteln,

menschlichem

Blut

oder

Plasma

hergestellt

wurden,

Möglichkeit von Infektionskrankheiten durch die Übertragung vor allem von noch

unbekannten oder neuen Erregern nicht völlig ausgeschlossen werden.

gibt

keine

Berichte

über

Virenübertragung

durch

Albumin,

gemäß

Spezifikationen des europäischen Arzneibuches in etablierten Verfahren hergestellt

wurde.

Anwendung von Human Albumin „Octapharma“ 25 % - Infusionsflasche mit

anderen Arzneimitteln

Bisher

sind

keine

Wechselwirkungen

zwischen

Humanalbumin

anderen

Medikamenten bekannt. Allerdings sollte Human Albumin „Octapharma“ 25 % -

Infusionsflasche

Lösung nicht mit anderen Medikamenten oder Blutkonserven in

einer Injektion gemischt werden

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen

anwenden,

kürzlich eingenommen / angewendet haben, oder beachsichtigen

andere Arzneimittel einzunehmen/anzuwenden.

Schwangerschaft und Stillzeit

Humanalbumin ist ein normaler Bestandteil des menschlichen Bluts. Es sind keine

schädlichen

Auswirkungen

Verwendung

dieses

Produkts

während

Schwangerschaft und Stillzeit bekannt.

Bei der Einstellung des Blutvolumens bei Schwangeren ist besondere Vorsicht

angebracht.

Verkehrstüchtigkeit und das Bedienen von Maschinen

Es gibt keine Hinweise darauf, dass Humanalbumin die Fähigkeit beeinträchtigt, ein

Fahrzeug zu lenken oder Maschinen zu bedienen.

3.

Wie

ist

Human

Albumin

„Octapharma“

25

%

-

Infusionsflasche

anzuwenden?

Human Albumin „Octapharma“ 25 % - Infusionsflasche Lösung ist fertig zur Infusion

(„Tropf“) in eine Vene. Vor der Anwendung sollte das Produkt auf Zimmer- oder

Körpertemperatur erwärmt werden. Die Dosierung und Infusionsrate (wie rasch

Albumin in die Vene infundiert wird) hängt von Ihrem Krankheitsbild ab. Ihr Arzt wird

entscheiden, welche Behandlung für Sie am besten ist.

Das Produkt kann an Frühgeborene und Dialysepatienten verabreicht werden.

Seite 4/7

Wenn

Sie

eine

größere

Menge

Human

Albumin

„Octapharma“

25

%

angewendet haben als Sie sollten:

Bei zu hoher Dosierung oder Infusionsrate könnten Kopfschmerzen, hoher Blutdruck

Atembeschwerden

auftreten.

diesem

Fall

sollte

Infusion

sofort

abgebrochen werden und Ihr Arzt wird entscheiden, ob eine andere Behandlung

erforderlich ist.

4.

Welche Nebenwirkungen sind möglich?

alle

Arzneimittel

kann

auch

Human

Albumin

„Octapharma“

Infusionsflasche Nebenwirkungen haben, die aber nicht bei jedem auftreten müssen.

Nebenwirkungen nach einer Infusion mit Humanalbumin sind selten.

Seltene Nebenwirkungen (Vorkommen bei mehr als 1 von 10000, aber weniger als 1

von 1000 Transfusionen):

allergische Reaktion oder Senkung des Blutdrucks

Sehr

seltene

Nebenwirkungen

(Vorkommen

weniger

10000

Transfusionen, einschließlich vereinzelter Berichte):

allergischer Schock, Verwirrtheit , Kopfschmerzen, beschleunigte oder verlangsamte

Herzfrequenz,

erhöhter

Blutdruck,

Hitzegefühl,

Atemnot,

Übelkeit,

Nesselsucht,

Schwellung

Bereich

Augen,

Mund

Nase,

Ausschlag,

vermehrtes

Schwitzen, Fieber, Schüttelfrost

Diese Symptome verschwinden jedoch meistens, wenn die Infusionsrate gesenkt

wird oder die Infusion abgebrochen wird.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt, Apotheker

oder das medizinische Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in

dieser Packungsbeilage angegeben sind. Sie können Nebenwirkungen auch direkt

anzeigen (siehe Details unten). Indem Sie Nebenwirkungen melden, können Sie

dazu beitragen, dass mehr Informationen über die Sicherheit dieses Arzneimittels zur

Verfügung gestellt werden.

Bundesamt für Sicherheit im Gesundheitswesen

Traisengasse 5

1200 WIEN

ÖSTERREICH

Fax: + 43 (0) 50 555 36207

Website: http://www.basg.gv.at/

Seite 5/7

5.

Wie

ist

Human

Albumin

„Octapharma“

25

%

-

Infusionsflasche

aufzubewahren?

Nicht über +25°C lagern. Das Behältnis in der Originalverpackung aufbewahren, um

den Inhalt vor Licht zu schützen. Nicht einfrieren.

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Haltbarkeitsdauer

Sie dürfen das Arzneimittel nach dem auf dem Etikett angegebenen Verfalldatum

nicht mehr anwenden.

Die Lösung sollte klar oder leicht opaleszierend sein. Keine Lösungen verwenden,

die trüb sind oder einen Satz haben.

Nach dem Öffnen des Behälters sollte der Inhalt sofort verbraucht werden.

Das Arzneimittel darf nicht im Abwasser oder Haushaltsabfall entsorgt werden.

Fragen Sie Ihren Apotheker wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht

mehr benötigen. Sie tragen damit zum Schutz der Umwelt bei..

6.

Inhalt der Packung und weitere Informationen

Was Human Albumin „Octapharma“ 25 % - Infusionsflasche enthält

Der Wirkstoff ist: 250 g/l Humanalbumin aus menschlichem Plasma.

Die sonstigen Bestandteile sind: Natrium (142,5-157,5 mmol/l), Kalium (max. 2,0

mmol/l), Stabilisatoren N-Acetyl-DL-Tryptophan und Caprylsäure sowie Wasser

für Injektionszwecke.

Wie Human Albumin „Octapharma“ 25% - Infusionsflasche aussieht und Inhalt

der Packung

Human

Albumin

„Octapharma“

eine

klare

oder

leicht

opaleszierende

Infusionslösung zur intravenösen Anwendung.

Die Infusionsflaschen sind in Abfüllgrößen von 50 ml bzw. 100 ml erhältlich.

1 Packung enthält:

Eine Infusionsflasche mit Lösung

Pharmazeutischer Unternehmer und Hersteller

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaerstr. 235

A-1100 Wien

Österreich

Zulassungsnummer: 2-00276

Seite 6/7

Diese Packungsbeilage wurde zuletzt überarbeitet im April 2015.

Seite 7/7

Die folgenden Informationen sind nur für Ärzte bzw. medizinisches

Fachpersonal bestimmt:

Dosierung und Art der Anwendung

Die Konzentration des Albuminpräparats, Dosierung und Infusionsgeschwindigkeit

sollten sich nach den individuellen Anforderungen des Patienten richten.

Dosierung

Die erforderliche Dosis hängt von der Körpermasse des Patienten, vom Schweregrad

des Traumas oder der Krankheit sowie vom Fortbestand des Flüssigkeits- und

Proteinverlusts ab. Die Dosis sollte anhand des Kreislaufvolumens und nicht anhand

des Plasma-Albuminspiegels bestimmt werden.

Bei der Verabreichung von Humanalbumin sollte die haemodynamische Leistung

regelmäßig überwacht werden; dazu gehört vor allem:

arterieller Blutdruck und Puls

zentraler Venendruck

Pulmonalkapillardruck

Harnproduktion

Elektrolyte

Hämatokrit/Hämoglobin

Dieses Produkt ist für Frühgeborene und Dialysepatienten geeignet.

Art der Anwendung

Humanalbumin kann direkt intravenös verabreicht werden.

Die Infusionsgeschwindigkeit muss den individuellen Umständen und der Indikation

angepasst werden.

Bei Austauschtransfusionen kann die Infusionsgeschwindigkeit höher sein und sollte

der Entnahmegeschwindigkeit angepasst werden.

Jede

Verabreichung

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Europe - EFSA - European Food Safety Authority Publications

14-1-2019


Human medicines highlights - January 2019

Human medicines highlights - January 2019

Human medicines highlights - January 2019

Europe - EMA - European Medicines Agency

14-1-2019


Applications for new human medicines under evaluation by the CHMP: January 2019

Applications for new human medicines under evaluation by the CHMP: January 2019

Applications for new human medicines under evaluation by the CHMP: January 2019

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

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: 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

21-11-2018

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Active substance: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast) - Orphan designation - Commission Decision (2018)7797 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/134/18

Europe -DG Health and Food Safety