Public Assessment Report - GOV.UK

1 Public Assessment Report Decentralised Procedure Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution (ipratropium bromide monohydrate) Procedure No: UK/H/5289/001/DC UK Licence No: PL 36390/0083 Cipla (EU) Limited Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution UK/H/5289/001/DC 2 LAY SUMMARY Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution (ipratropium bromide monohydrate; pressurised inhalation , solution; 20 micrograms per actuation) This is a summary of the Public Assessment Report (PAR) for Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution (PL 36390/0083; UK/H/5289/001/DC).

2 It explains how Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution. For practical information about using Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution, patients should read the package leaflet or contact their doctor or pharmacist. The product may be referred to as Ipravent CFC-Free Inhaler in this Report . What is Ipravent CFC-Free Inhaler and what is it used for? Ipravent CFC-Free Inhaler is used to make breathing easier for people with asthma or chronic obstructive pulmonary disease (COPD), often referred to as chronic bronchitis.

3 Ipravent CFC-Free Inhaler is not to be used in children, 12 years of age and younger or adolescents 13 to 17 years of age. Ipravent CFC-Free Inhaler is a hybrid medicine. This means that Ipravent CFC-Free Inhaler contains the same active substance as, and is similar to, a reference medicine already authorised in the European Union (EU) called Atrovent dosis-a rosol 20 g/dosis, a rosol, oplossing (NL RVG 2683; Boehringer Ingelheim ) first approved in the Netherlands in a chlorofluorocarbon (CFC)-free hydrofluoroalkane (HFA)-containing formulation in November 2001. The corresponding reference product in the UK is ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation solution (Boehringer Ingelheim Limited, UK; PL 00015/0266), approved in the UK on 01 March 2004.

4 How does Ipravent CFC-Free Inhaler work? The active substance, ipratropium bromide monohydrate, belongs to a group of medicines called bronchodilators. In asthma or COPD, patients may have difficulty in breathing, shortness of breath, wheezing or tightness in the chest. Ipravent CFC-Free Inhaler works by opening up airways. How is Ipravent CFC-Free Inhaler used? The patient should always use Ipravent CFC-Free Inhaler exactly as instructed by his/her doctor. The patient should check with his/her doctor if unsure. Ipravent CFC-Free Inhaler is inhaled through the mouth. The inhaler can be used with a device called Aerochamber Plus spacer. This may be useful for people who find it difficult to synchronise breathing in and inhaler actuation.

5 Please talk to your doctor if you have difficulties to use the Ipravent Inhaler. The usual recommended dose is 1 or 2 puffs to be inhaled three or four times daily. However, in early treatment some patients may need up to 4 puffs at a time to obtain maximum effect. The recommended dose should not be exceeded. Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution UK/H/5289/001/DC 3 Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment. Ipravent CFC-Free Inhaler can only be obtained on prescription. What benefits of Ipravent CFC-Free Inhaler has been shown in studies?

6 As Ipravent CFC-Free Inhaler is a hybrid medicine, studies in patients have been limited to tests to determine it is therapeutically equivalent to the reference medicine, ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation solution (Boehringer Ingelheim Limited, UK). Two medicines are therapeutically equivalent when they produce the same measure of therapeutic effect in the body. What are the benefits and risks of Ipravent CFC-Free Inhaler? Because Ipravent CFC-Free Inhaler is a hybrid medicine and is therapeutically equivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine. What are the possible side effects from Ipravent CFC-Free Inhaler?

7 Like all medicines, Ipravent CFC-Free Inhaler can cause side effects, although not everybody gets them. Since Ipravent CFC-Free Inhaler is a generic hybrid medicine, the benefits and possible side effects are taken as being the same as the reference medicine. For the full list of all side effects reported with Ipravent CFC-Free Inhaler, see section 4 of the package leaflet. For the full list of restrictions, see the package leaflet for Ipravent CFC-Free Inhaler. Why is Ipravent CFC-Free Inhaler approved? It was concluded that, in accordance with EU requirements, Ipravent CFC-Free Inhaler has been shown to have comparable quality and to be therapeutically equivalent to ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation solution (Boehringer Ingelheim Limited, UK).

8 Therefore, the view was that, as for ATROVENT Inhaler CFC-Free 20 micrograms/actuation pressurised inhalation solution (Boehringer Ingelheim Limited, UK), the benefit outweighs the identified risk. What measures are being taken to ensure the safe and effective use of Ipravent CFC-Free Inhaler? Safety information has been included in the Summary of Product Characteristics and the package leaflet for Ipravent CFC-Free Inhaler, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Ipravent CFC-Free Inhaler Ireland and the UK agreed to grant a Marketing Authorisation to Cipla (EU) Limited for Ipravent CFC-Free Inhaler on 06 October 2013. A Marketing Authorisation was granted in the UK on 05 November 2013.

9 The full PAR for Ipravent CFC-Free Inhaler follows this summary. For more information about treatment with Ipravent CFC-Free Inhaler, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in January 2019. Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution UK/H/5289/001/DC 4 SCIENTIFIC DISCUSSION TABLE OF CONTENTS I Introduction Page 5 II Quality aspects Page 6 III Non-clinical aspects Page 7 IV Clinical aspects Page 8 V User consultation Page 9 VI Overall conclusion, benefit/risk Assessment and recommendation Page 9 Annex 1 - Table of content of the PAR update for MRP and DCP Page 11 Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution UK/H/5289/001/DC 5 I INTRODUCTION Based on the review of the data on quality, safety and efficacy.

10 The UK and Ireland considered that the application for Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution (PL 36390/0083; UK/H/5289/001/DC) could be approved. Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation , solution may be referred to as Ipravent CFC free Inhaler in this Report . The product is a prescription-only medicine (POM). Ipravent CFC free Inhaler is indicated for the regular treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD) and chronic asthma. Ipravent CFC free Inhaler is not indicated for use in children, 12 years of age and younger or adolescents 13 to 17 years of age. The product is not to be used with any spacing device.