Beclometasone/Formoterol Polpharma 100 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Zusammenfassung 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)

Beclometasone dipropionate/for­moterol fumarate dihydrate

Druckgasinhala­tion, Lösung; 100/6 mcg pro Anwendung

Administrative Information:

Wirkstoffe	Beclometasondi­propionat (Ph.Eur.) Formoterolfumarat-Dihydrat (Ph.Eur.)
ATC-Code	R03AK08
Darreichungsform	Druckgasinhalation, Lösung
Art der Anwendung	zur Inhalation
Inhaber der Zulassung	Zaklady Farmaceutyczne Polpharma S.A. ul. Pelplinska 19 83–200 STAROGARD GDANSKI, POMORSKIE Polen
Zulassungsnummer	7007078.00.00
Datum der Zulassung	20.11.2023
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	0.3 / 20.06.2022
Datum der Genehmigung des RMPs	20.11.2023

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. Dezember 2023 veröffen­tlicht.

• (1)

• (2)

• Part III: Pharmacovigilance Plan (including post-authorisation safety studies)

• 111.1 Routine pharmacovigilance activities

Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection: None.

• III.2 Additional pharmacovigilance activities

None proposed.

• III.3 Summary Table of additional Pharmacovigilance activities

Not applicable.

• Part IV: Plans for post-authorisation efficacy studies

None proposed.

Part V: Risk minimisation measures (including evaluation of the effectiveness of risk minimisation activities)

Risk Minimisation Plan

The safety information in the product information is aligned to the reference medicinal product Fostair®.

Part VI: Summary of the risk management plan

Summary of risk management plan for BECLOCOMB (Beclometasone dipropionate and formoterol fumarate dihydrate)

This is a summary of the risk management plan (RMP) for BECLOCOMB. No important risks/safety concerns were identified for BECLOCOMB.

BECLOCOMB summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on BECLOCOMB should be used.

• I. The medicine and what it is used for

BECLOCOMB is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate in patients not adequately controlled with inhaled corticosteroids and ‚as needed‘ inhaled rapid-acting beta2-agonist or patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. And also indicated for symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. It contains Beclometasone dipropionate and formoterol fumarate dihydrate as the active substance and it is for inhalation use.

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

No important risks were identified for BECLOCOMB.

However, measures to minimise the risks for BECLOCOMB are:

• 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

No risks were identified for BECLOCOMB.

Summary of safety concerns
Important identified risks	none
Important potential risks	none
Missing information	none

• II.B Summary of important risks