Erwinase 10 000 E./Durchstechflasche Pulver zur Herstellung einer Injektions-/Infusionslösung - Zusammengefasste Informationen

Zusammenfassung des Risikomanagement-Plans gemäß § 34Zusammenfassung des Risikomanagement-Plans gemäß § 34

Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the

Medicinal Products Act(2)

Crisantaspase Porton Biopharma

Administrative Information:

Wirkstoff	Crisantaspase
ATC-Code	L01XX02
Darreichungsform	Pulver zur Herstellung einer Injektions-/Infusionslösung
Art der Anwendung	intramuskuläre Anwendungintra­venöse Anwendung
Inhaber der Zulassung	Porton Biopharma Limited Lee View House, 13 South Terrace T12 T0CT CORK, CO. CORK Irland
Zulassungsnummer	7005446.00.00
Datum der Zulassung	15.10.2021
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	1.1 / 10.02.2021
Datum der Genehmigung des RMPs	15.10.2021

Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) des o. g. Arzneimittels ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicher­heit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass dieses Arzneimittel so sicher wie möglich angewendet wird.

Weitere Informationen zu RMP-Zusammenfassungen finden Sie(nur auf Englisch verfügbar).

Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimittel gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.

Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 29. November 2021 veröffen­tlicht.

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Part VI: Summary of the risk management planSummary of risk management plan for Crisantaspase Porton Biopharma (Crisantaspase (L-asparaginase from Erwinia chrysanthemi ))

This is a summary of the risk management plan (RMP) for Crisantaspase Porton Biopharma. The RMP details important risks of Crisantaspase Porton Biopharma, how these risks can be minimised, and how more information will be obtained about Crisantaspase Porton Biopharma's risks and uncertainties (missing information).

Crisantaspase Porton Biopharma’s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Crisantaspase Porton Biopharma should be used.

I.    The medicine and what it is used for

Crisantaspase Porton Biopharma is authorised as part of a treatment regimen for the treatment of patients with acute lymphoblastic leukaemia (see SmPC for the full indication). It contains Crisantaspase as the active substance and it is given by injection or infusion into the vein or injection into the muscle.

II.    Risks associated with the medicine and activities to minimise or further characterise the risksII. Risks associated with the medicine and activities to minimise or further characterise the risks

Important risks of Crisantaspase Porton Biopharma, together with measures to minimise such risks and the proposed studies for learning more about Crisantaspase Porton Biopharma’s risks, are outlined below.

Measures to minimise the risks identified for medicinal products can be:

Specific information, such as warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals; Important advice on the medicine’s pac­kaging; The authorised pack size — the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly; The medicine’s legal status — the way a medicine is supplied to the patient (e.g. with or without prescription) can help to minimise its risks.

Together, these measures constitute routine risk minimisation measures.

In addition to these measures, information about adverse reactions is collected continuously and regularly analysed so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.

II.A List of important risks and missing information

Important risks of Crisantaspase Porton Biopharma are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely administered. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Crisantaspase Porton Biopharma. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. on the long-term use of the medicine).

Table II.1: Lists of Important Risks and Missing Information

Summary of Safety concerns
Important identified risks	None
Important potential risks	None
Missing information	None