Public Assessment Report - GOV.UK

1 Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 1 Public Assessment Report Decentralised Procedure Pantoprazole 40 mg powder for solution for injection (pantoprazole sodium sesquihydrate) Procedure No: UK/H/5517/001/DC UK Licence No: PL 01656/0198 Krka , Novo mesto Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 2 LAY summary Pantoprazole 40 mg powder for solution for injection (pantoprazole sodium sesquihydrate, powder for solution for injection, 40 mg) This is a summary of the Public Assessment Report (PAR) for Pantoprazole 40 mg powder for solution for injection (PL 01656/0198; UK/H/5517/001/DC). It explains how Pantoprazole 40 mg powder for solution for injection was assessed and its authorisation recommended, as well as its conditions of use.

2 It is not intended to provide practical advice on how to use Pantoprazole 40 mg powder for solution for injection. For practical information about using Pantoprazole 40 mg powder for solution for injection, patients should read the package leaflet or contact their doctor or pharmacist. The product may be referred to as Pantoprazole powder for solution for injection in this Report . What is Pantoprazole powder for solution for injection and what is it used for? Pantoprazole powder for solution for injection is a generic medicine. This means that Pantoprazole powder for solution for injection is similar to a reference medicine already authorised in the European Union (EU) called Pantozol 40mg Pulver zur Herstellung einer Injektionsl sung (Nycomed GmbH, Germany). Pantoprazole powder for solution for injection contains the active substance pantoprazole (as pantoprazole sodium sesquihydrate).

3 Pantoprazole powder for solution for injection is used for treating: reflux oesophagitis, which is an inflammation of the oesophagus (the tube which connects the throat to the stomach) accompanied by the regurgitation of stomach acid; stomach and duodenal ulcers; Zollinger-Ellison Syndrome and other conditions producing too much acid in the stomach. How is Pantoprazole 40 mg powder for solution for injection used? Pantoprazole powder for solution for injection is given by a health professional. It is prepared as a solution before it is given as an injection into a vein over a period of 2 15 minutes. The usual dose is: For gastric ulcers, duodenal ulcers and reflux oesophagitis: One vial (40 mg pantoprazole) a day. For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced: Two vials (80 mg pantoprazole) a day.

4 The doctor may later adjust the dose depending on the amount of stomach acid the patient produces. If the patient is prescribed more than two vials (80 mg) a day, the injections are given in two equal doses. The doctor may prescribe a temporary dose of more than four vials (160 mg) a day. If the patient s stomach acid level needs to be controlled rapidly, a starting dose of 160 mg (four vials) should be enough to lower the amount of stomach acid sufficiently. Special patient groups: - In patients who suffer from severe liver problems the daily injection the recommended dose is 20 mg (half a vial). - Children (under 18 years). These injections are not recommended for use in children. Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 3 For further information on how Pantoprazole powder for solution for injection is used, please see the summary of Product Characteristics available on the MHRA website.

5 Pantoprazole powder for solution for injection can only be obtained on prescription. How does Pantoprazole powder for solution for injection work? Pantoprazole is a selective proton pump inhibitor . Pantoprazole reduces the amount of acid produced in the stomach. How has Pantoprazole powder for solution for injection been studied? The company (Krka , N ovo mesto) has provided data from the published literature on pantoprazole. No additional studies were needed as Pantoprazole powder for solution for injection is a generic medicine that is an aqueous solution that is given by injection and contains the same active substance as the reference medicine, Pantozol 40mg Pulver zur Herstellung einer Injektionsl sung (Nycomed GmbH, Germany). What are the benefits and risks of Pantoprazole powder for solution for injection?

6 Because Pantoprazole powder for solution for injection is considered to be a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine. Why is Pantoprazole powder for solution for injection approved? It was concluded that, in accordance with EU requirements, Pantoprazole powder for solution for injection has been shown to have comparable quality and is considered to be bioequivalent to Pantozol 40mg Pulver zur Herstellung einer Injektionsl sung (Nycomed GmbH). Therefore, the view was that, as for Pantozol 40mg Pulver zur Herstellung einer Injektionsl sung (Nycomed GmbH), the benefits outweigh the identified risks. What measures are being taken to ensure the safe and effective use of Pantoprazole powder for solution for injection?

7 A Risk Management Plan has been developed to ensure that Pantoprazole powder for solution for injection is used as safely as possible. Based on this plan, safety information has been included in the summary of Product Characteristics and the package leaflet for Pantoprazole powder for solution for injection, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Pantoprazole powder for solution for injection. A Marketing Authorisation was granted in the UK on 07 April 2014. The full PAR approved for Pantoprazole 40 mg powder for solution for injection follows this summary . For more information about treatment with Pantoprazole 40 mg powder for solution for injection, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in June 2014.

8 Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 4 TABLE OF CONTENTS Module 1: Information about the initial procedure Page 5 Module 2: summary of Product Characteristics Page 6 Module 3: Patient Information Leaflet Page 7 Module 4: Labelling Page 8 Module 5: Scientific discussion during the initial procedure Page 11 I Introduction II About the product III Scientific overview and discussion Quality aspects Non-clinical aspects Clinical aspects IV Overall conclusion and benefit/risk Assessment Module 6: Steps taken after the initial procedure Page 18 Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 5 Module 1 Information about the initial procedure Product Name Pantoprazole 40 mg powder for solution for injection Type of Application Generic, Article 10(1) Active Substance Pantoprazole sodium sesquihydrate Form Powder for solution for injection Strength 40 mg per vial MA Holder Krka, , Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia Reference Member State (RMS) UK Concerned Member States (CMS)

9 Bulgaria, Latvia, Lithuania, and Estonia Procedure Number UK/H/5517/001/DC Timetable Day 160 05 March 2013 Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 6 Module 2 summary of Product Characteristics In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website. Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 7 Module 3 Patient Information Leaflet In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 8 Module 4 Labelling The Marketing Authorisation Holder has submitted the text version only and has committed to submitting mock-up livery to the regulatory authorities for approval before packs are marketed.

10 Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 9 Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 10 Pantoprazole 40 mg powder for solution for injection UK/H/5517/001/DC 11 Module 5 Scientific discussion during the initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Member States considered that the application for Pantoprazole 40 mg powder for solution for injection (PL 01656/0198; UK/H/5517/001/DC) could be approved. The product is a prescription-only medicine (POM) and is indicated for: reflux oesophagitis; gastric and duodenal ulcer; Zollinger Ellison Syndrome and other pathological hypersecretory conditions. The application was submitted using the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS) and Bulgaria, Latvia, Lithuania and Estonia as Concerned Member States (CMS).