Electronic Product Information (ePI) for the European Union ALTEPLASE 50 mg

Important information for ALTEPLASE 50 mg:

As part of our ongoing focus on managing and minimizing current supply constraints for the Boehringer Ingelheim product ACTILYSE containing alteplase in the European Union (EU), additional, limited, temporary supply of FDA-approved ALTEPLASE 50 mg vials has been authorized by the national competent authorities in France, Germany, Italy and Spain.

ALTEPLASE 50 mg contains alteplase as an active pharmaceutical ingredient. Please be aware that the Boehringer Ingelheim product ACTILYSE also contains alteplase. However, each of the products has slightly different recommendations in the product information, including indications and eligibility of patients. Please refer to the package leaflet of ALTEPLASE 50 mg for full details.

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English

The corresponding product information and information letter for hospitals and HCPs are available for download here.

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France

Les informations sur le produit et la lettre d’information destinée aux hôpitaux et aux professionnels de santé peuvent être téléchargées ici.

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Deutschland

Die entsprechende Produktinformation und das Informationsschreiben für Krankenhäuser und Angehörige der Fachkreise stehen hier zum Download bereit.

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España

La información del producto correspondiente y la carta de información para hospitales y profesionales de la salud están disponibles para descargar aquí.

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Italia

Le informazioni di prodotto e la lettera informativa per ospedali e operatori sanitari sono disponibili cliccando qui.