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  • MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES, HARD, PL 17780/0523-0525 AND 0583

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    Public Assessment Report

    Decentralised Procedure

    Omeprazole 10mg Gastro-resistant Capsules, hard

    Omeprazole 20mg Gastro-resistant Capsules, hard

    Omeprazole 40mg Gastro-resistant Capsules, hard

    (UK/H/4423/001-003/DC)

    Omeprazole 20mg Gastro-resistant Capsules, hard

    (UK/H/5144/001/DC)

    PL 17780/0523

    PL 17780/0524

    PL 17780/0525

    PL 17780/0583

    Winthrop Pharmaceuticals UK Limited

  • MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES, HARD, PL 17780/0523-0525 AND 0583

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    Lay summary

    The Medicines and Healthcare products Regulatory Agency (MHRA) granted Winthrop Pharmaceuticals UK Limited (trading as Zentiva) Marketing Authorisations for the medicinal products Omeprazole 10mg Gastro-resistant Capsules, hard (product licence number: PL 17780/0523), Omeprazole 20mg Gastro-resistant Capsules, hard (PL 17780/0524), Omeprazole 40mg Gastro-resistant Capsules, hard (PL 17780/0525) and Omeprazole 20mg Gastro-resistant Capsules, hard (PL 17780/0583) on 7 May 2013. These medicines are available on prescription only. Omeprazole Capsules belong to a group of medicines known as the proton pump inhibitors. They work by reducing the amount of acid that your stomach produces. Omeprazole Capsules are used to treat the following conditions: In adults:

    Gastro-esophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.

    Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). Ulcers which are infected with bacteria called Helicobacter pylori. If you have this

    condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

    Ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazole capsules can also be used to stop ulcers from forming if you are taking NSAIDs.

    Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

    In children: Children over 1 year of age and weighing 10 kg or more

    Gastro-esophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.

    Children and adolescents over 4 years of age Ulcers which are infected with bacteria called Helicobacter pylori. If your child has

    this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

    No new or unexpected safety concerns arose from these applications. It was judged that the benefits of taking Omeprazole Capsules outweigh the risks; hence Marketing Authorisations have been granted.

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    TABLE OF CONTENTS

    Module 1: Information about Decentralised Procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Product Information Leaflet Page 6 Module 4: Labelling Page 7 Module 5: Scientific Discussion During Initial Procedure Page 28

    I Introduction II About the Products III Scientific Overview and Discussion III.1 Quality aspects III.2 Non-clinical aspects III.3 Clinical aspects IV Overall conclusion and Benefit-Risk Assessment Module 6: Steps taken after initial procedure Page 39

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    Module 1

    Information about Decentralised Procedure Names of the products in the Reference Member State

    Omeprazole 10mg Gastro-resistant Capsules, hard Omeprazole 20mg Gastro-resistant Capsules, hard Omeprazole 40mg Gastro-resistant Capsules, hard Omeprazole 20mg Gastro-resistant Capsules, hard

    Type of application Article 10 (1), generic

    Name of the drug substance Omeprazole

    Pharmacotherapeutic classification (ATC code) of the medicinal products

    Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), proton pump inhibitors (A02BC01)

    Pharmaceutical form and strengths of the medicinal products

    Gastro-resistant capsule, hard; 10 mg, 20 mg and 40 mg

    Reference numbers for the Decentralised Procedure

    UK/H/4423/001-003/DC UK/H/5144/001/DC

    Reference Member State United Kingdom

    Member States concerned

    UK/H/4423/001-003/DC: BG, CZ, DE, ES, FR, HU, IT, PL, PT, RO, SI, SK UK/H/5144/001/DC: DE

    Start date of the Decentralised Procedure 19 March 2012

    End date of the Decentralised Procedure 14 March 2013 (day 210)

    Marketing Authorisation numbers PL 17780/0523 PL 17780/0524 PL 17780/0525 PL 17780/0583

    Name and address of the authorisation holder

    Winthrop Pharmaceuticals UK Limited (Trading as Zentiva) One Onslow Street Guildford Surrey GU1 4YS UK

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    Module 2

    Summary of Product Characteristics In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPC) for products granted Marketing Authorisations at a national level are available on the MHRA website.

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    Module 3

    Product Information Leaflet

    In accordance with Directive 2010/84/EU the Patient Information Leaflets (PIL) for products granted Marketing Authorisations at a national level are available on the MHRA website.

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    Module 4

    Labelling

    The following text is the approved label text for the products. No label mock-ups have been provided. In accordance with medicines legislation, the products shall not be marketed in the UK until approval of the label mock-ups has been obtained.

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    Omeprazole 10mg Gastro-resistant Capsules, hard (PL 17780/0523):

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    Omeprazole 20mg Gastro-resistant Capsules, hard (PL 17780/0524):

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    Omeprazole 40mg Gastro-resistant Capsules, hard ((PL 17780/0525):

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  • MHRA PAR; OMEPRAZOLE 10MG, 20MG AND 40MG GASTRO-RESISTANT CAPSULES, HARD, PL 17780/0523-0525 AND 0583

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    Omeprazole 20mg Gastro-resistant Capsules, hard ((PL 17780/0583):

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    Module 5

    Scientific Discussion During Initial Procedure

    I. INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Member States considered that the application for Omeprazole 10mg, 20mg and 40mg Gastro-resistant Capsules, hard could be approved. These prescription only medicines are used to treat the following conditions in adults:

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