Emadine

emedastine

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Emadine?

Emadine is a clear eye-drop solution. It contains the active substance emedastine (0.5 mg/ml). Emadine is available in a bottle and in single-dose containers.

What is Emadine used for?

Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever). These symptoms include itching, redness and swelling.

Emadine is used in adults and children aged three years and older.

The medicine can only be obtained with a prescription.

How is Emadine used?

Emadine is given as one drop in the affected eye(s) twice a day. Its effects have not been studied beyond six weeks. If more than one type of eye treatment is being used, each one should be given at least 10 minutes apart and any eye ointments should be given last.

Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.

How does Emadine work?

The active substance in Emadine, emedastine, is an antihistamine. It works by blocking the receptors that histamine normally attaches to. Histamine is a substance in the body that causes allergic symptoms. When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.

How has Emadine been studied?

Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over. The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.

The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an 'allergen challenge'. This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.

What benefit has Emadine shown during the studies?

Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis. In both groups of patients, itching scores fell from around 5.1 at the start of the study, to around 3.8 after five minutes and around 2.7 after two hours. Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours. In the long term, the itching scores fell from an average of around 3.9 on the first day, falling to 0.8 for Emadine and 2.0 for levocabastine after six weeks. For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.

Similar results were seen in adults and in children.

The results of the allergen challenge tests supported these results.

What is the risk associated with Emadine?

The most common side effects with Emadine (which may affect between 1 and 2 patients in 100) are eye pain, eye pruritus (itchy eye) and conjunctival hyperaemia (increased blood flow to the eye, leading to redness).

The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses. Therefore, care should be taken by people who wear soft contact lenses. For the full list of all side effects and restrictions with Emadine, see the package leaflet.

Why has Emadine been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine’s benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis. The Committee recommended that Emadine be given marketing authorisation.

Other information about Emadine:

The European Commission granted a marketing authorisation valid throughout the European Union for Emadine on 27 January 1999.

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

Name Language First published Last updated
Emadine : EPAR - Summary for the public BG = bălgarski 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public ES = español 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public CS = čeština 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public DA = dansk 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public DE = Deutsch 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public ET = eesti keel 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public EL = elliniká 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public EN = English 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public FR = français 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public IT = italiano 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public LV = latviešu valoda 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public LT = lietuvių kalba 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public HU = magyar 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public MT = Malti 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public NL = Nederlands 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public PL = polski 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public PT = português 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public RO = română 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public SK = slovenčina 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public SL = slovenščina 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public FI = suomi 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public SV = svenska 2009-02-11 2014-05-23
Emadine : EPAR - Summary for the public HR = Hrvatski 2009-02-11 2014-05-23

This EPAR was last updated on 02/06/2017 .

Authorisation details

Product details

Product details for Emadine
NameEmadine
Agency product numberEMEA/H/C/000223
Active substance

emedastine

International non-proprietary name (INN) or common name

emedastine

Therapeutic area Conjunctivitis, Allergic
Anatomical therapeutic chemical (ATC) code S01GX06

Publication details

Publication details for Emadine
Marketing-authorisation holder

Novartis Europharm Limited

Revision20
Date of issue of marketing authorisation valid throughout the European Union27/01/1999

Contact address:

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

Product information

16/05/2017  Emadine -EMEA/H/C/000223 -T/0044

Name Language First published Last updated
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02
Emadine : EPAR - Product Information HR = Hrvatski 2009-01-30 2017-06-02

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
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  
Emadine : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21  

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Symptomatic treatment of seasonal allergic conjunctivitis.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Emadine : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-10-21  
Emadine : EPAR - Scientific Discussion HR = Hrvatski 2005-10-21  

Authorised

This medicine is approved for use in the European Union