Enzepi

pancreas powder

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This is a summary of the European public assessment report (EPAR) for Enzepi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Enzepi.

For practical information about using Enzepi, patients should read the package leaflet or contact their doctor or pharmacist.

What is Enzepi and what is it used for?

Enzepi is a medicine used to treat adults and children whose pancreas does not produce enough enzymes (a condition known as pancreatic insufficiency) due to cystic fibrosis or other conditions such as pancreatic cancer. Pancreas enzymes are needed to digest fats, carbohydrates and proteins. A lack of these enzymes leads to poor growth, weight loss, abdominal pain and diarrhoea.

The active substance in Enzepi is pancreas powder which is obtained from pig pancreas. It contains enzymes that help with the digestion of fats, carbohydrates and proteins.

How is Enzepi used?

Enzepi is available as capsules (5,000; 10,000; 25,000 and 40,000 units). The appropriate dose depends on the symptoms of the disease, amount of fat in the stool, fat content of the diet and the patient’s weight. Treatment is started at a low dose, which the doctor may then increase slowly until an appropriate dose is reached.

Enzepi should be taken during meals or snacks with a drink of water or juice. Capsules should be swallowed whole and not chewed or crushed. For patients who cannot swallow capsules, the capsules may be opened and the content mixed with a small amount of acidic food such as fruit puree which should be swallowed immediately without chewing.

Enzepi can only be obtained with a prescription. For further information, see the package leaflet.

How does Enzepi work?

The active substance of Enzepi, pancreas powder, is intended to replace missing enzymes in patients whose pancreas does not produce sufficient amounts of them. Enzepi will therefore help the body  absorb nutrients better, especially fats.

Pancreas powder is a well-known substance that has been authorised in the treatment of pancreatic insufficiency for many years.

What benefits of Enzepi have been shown in studies?

Enzepi has been shown to be as effective as an already authorised medicine containing pancreas powder and used in pancreatic insufficiency. In one main study involving 96 patients, treatment with Enzepi led to the absorption of 84% of the fats consumed by patient over 72 hours compared with 85% absorption with the already authorised medicine.

What are the risks associated with Enzepi?

The most common side effects with Enzepi (which may affect more than 1 in 100 people) are effects on the gut (abdominal pain, bloating, diarrhoea, vomiting, constipation and nausea) and headache. In clinical trials most side effects were mild to moderate in severity. The most important serious side effects observed with all pancreatic enzyme medicines are anaphylactic (allergic) reactions and fibrosing colonopathy (scarring and thickening of the bowel wall).

For the full list of restrictions and all side effects reported with Enzepi, see the package leaflet.

Why is Enzepi approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Enzepi’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP considered that the use of pancreas powder to treat pancreatic insufficiency has been well established in medical practice for more than 20 years. Enzepi was shown to be as effective as the already well-known marketed medicine. In terms of safety, Enzepi’s side effects are comparable to other marketed products.

What measures are being taken to ensure the safe and effective use of Enzepi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enzepi have been included in the summary of product characteristics and the package leaflet.

Other information about Enzepi

The European Commission granted a marketing authorisation valid throughout the European Union for Enzepi on 29 June 2016.

For more information about treatment with Enzepi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Enzepi : EPAR - Summary for the public BG = bălgarski 2016-07-19  
Enzepi : EPAR - Summary for the public ES = español 2016-07-19  
Enzepi : EPAR - Summary for the public CS = čeština 2016-07-19  
Enzepi : EPAR - Summary for the public DA = dansk 2016-07-19  
Enzepi : EPAR - Summary for the public DE = Deutsch 2016-07-19  
Enzepi : EPAR - Summary for the public ET = eesti keel 2016-07-19  
Enzepi : EPAR - Summary for the public EL = elliniká 2016-07-19  
Enzepi : EPAR - Summary for the public EN = English 2016-07-19  
Enzepi : EPAR - Summary for the public FR = français 2016-07-19  
Enzepi : EPAR - Summary for the public IT = italiano 2016-07-19  
Enzepi : EPAR - Summary for the public LV = latviešu valoda 2016-07-19  
Enzepi : EPAR - Summary for the public LT = lietuvių kalba 2016-07-19  
Enzepi : EPAR - Summary for the public HU = magyar 2016-07-19  
Enzepi : EPAR - Summary for the public MT = Malti 2016-07-19  
Enzepi : EPAR - Summary for the public NL = Nederlands 2016-07-19  
Enzepi : EPAR - Summary for the public PL = polski 2016-07-19  
Enzepi : EPAR - Summary for the public PT = português 2016-07-19  
Enzepi : EPAR - Summary for the public RO = română 2016-07-19  
Enzepi : EPAR - Summary for the public SK = slovenčina 2016-07-19  
Enzepi : EPAR - Summary for the public SL = slovenščina 2016-07-19  
Enzepi : EPAR - Summary for the public FI = suomi 2016-07-19  
Enzepi : EPAR - Summary for the public SV = svenska 2016-07-19  
Enzepi : EPAR - Summary for the public HR = Hrvatski 2016-07-19  

This EPAR was last updated on 19/07/2016 .

Authorisation details

Product details

Product details for Enzepi
NameEnzepi
Agency product numberEMEA/H/C/002070
Active substance

pancreas powder

International non-proprietary name (INN) or common name

pancreas powder

Therapeutic area Exocrine Pancreatic Insufficiency
Anatomical therapeutic chemical (ATC) code A09AA02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Enzepi
Marketing-authorisation holder

Allergan Pharmaceuticals International Ltd

Revision1
Date of issue of marketing authorisation valid throughout the European Union29/06/2016

Contact address:

Clonshaugh Business & Technology Park
Coolock
Dublin
D17 E400
Ireland

Product information

Product information

02/09/2016  Enzepi -EMEA/H/C/002070 -T/01

Name Language First published Last updated
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16
Enzepi : EPAR - Product Information HR = Hrvatski 2016-07-19 2016-09-16

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  
Enzepi : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19  

Pharmacotherapeutic group

Digestives, incl. enzymes

Therapeutic indication

Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).
Enzepi is indicated in infants, children, adolescents and adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Enzepi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-09-16  

Initial marketing-authorisation documents

Name Language First published Last updated
Enzepi : EPAR - Public assessment report HR = Hrvatski 2016-07-19  
CHMP summary of opinion for Enzepi HR = Hrvatski 2016-04-29  

Authorised

This medicine is approved for use in the European Union