DuoTrav

travoprost / timolol

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This is a summary of the European public assessment report (EPAR) for DuoTrav. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for DuoTrav.

What is DuoTrav?

DuoTrav is a clear eye-drop solution. It contains two active substances: travoprost (40 micrograms per millilitre) and timolol (5 mg/ml).

What is DuoTrav used for?

DuoTrav is used to reduce the pressure inside the eye. It is used in adults with ‘open-angle glaucoma’ or ‘ocular hypertension’ who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).

Ocular hypertension is when the pressure in the eye is higher than normal. In open-angle glaucoma, the high pressure is caused by fluid being unable to drain out of the eye.

DuoTrav can only be obtained with a prescription.

How is DuoTrav used?

The dose of DuoTrav is one drop in the affected eye(s) once a day, in the morning or evening, at the same time every day. If more than one type of eye drop is being used, each one should be given at least five minutes apart.

How does DuoTrav work?

When the pressure inside the eye rises, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can result in serious vision loss and even blindness. By lowering the pressure, DuoTrav reduces the risk of damaging these structures.

DuoTrav contains two active substances, travoprost and timolol, which lower the pressure in the eye in different ways. Travoprost is a prostaglandin analogue (a man-made copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Travoprost on its own has been authorised in the European Union as Travatan since 2001. Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been used to treat glaucoma since the 1970’s. The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.

How has DuoTrav been studied?

DuoTrav has been studied in five main studies involving a total of 1,482 patients (aged 18 to 91) with open-angle glaucoma or ocular hypertension. The studies lasted between six weeks and 12 months. One study compared DuoTrav taken in the morning with DuoTrav taken in the evening. Three studies compared DuoTrav with travoprost and timolol either given on their own, or together but as separate eye drops. The fifth was a 12-month study that compared DuoTrav with eye drops containing a combination of latanoprost (another prostaglandin analogue) and timolol.

In all of the studies, the main measure of effectiveness was the change in pressure inside the eye measured in ‘millimetres of mercury’ (mmHg). In a patient with glaucoma, the eye pressure is usually higher than 21 mmHg.

What benefit has DuoTrav shown during the studies?

DuoTrav reduced the pressure inside the eye by about a third in all of the studies (the average reduction was about 8-10 mmHg).

DuoTrav taken in the evening was as effective as DuoTrav taken in the morning. DuoTrav was more effective at reducing the pressure inside the eye than timolol on its own, or travoprost on its own. It was as effective as the two medicines given as separate eye drops, and as effective as eye drops containing both latanoprost and timolol.

What is the risk associated with DuoTrav?

The most common side effects with DuoTrav (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to redness) and eye irritation. For the full list of all side effects reported with DuoTrav, see the package leaflet.

DuoTrav should not be used in people who may be hypersensitive (allergic) to travoprost, timolol (and other beta-blockers), or any of the other ingredients. DuoTrav must not be used in people with asthma or severe lung disease, or in people with some heart conditions. It must also not be used in people with severe allergic rhinitis (inflammation of the nasal passages caused by an allergy) and corneal dystrophies (disorders that cause clouding of the cornea, the transparent layer in front of the eye).

DuoTrav contains benzalkonium chloride, which is known to discolour soft contact lenses. Therefore, care should be taken by people who wear soft contact lenses. DuoTrav may cause the iris of the eye to change colour (darken) and the eyelashes to thicken, darken or lengthen.

Why has DuoTrav been approved?

The CHMP decided that DuoTrav’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about DuoTrav

The European Commission granted a marketing authorisation valid throughout the European Union, for DuoTrav to Alcon Laboratories (UK) Limited on 24 April 2006. The marketing authorisation is valid for an unlimited period.

Name Language First published Last updated
DuoTrav : EPAR - Summary for the public BG = bălgarski 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public ES = español 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public CS = čeština 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public DA = dansk 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public DE = Deutsch 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public ET = eesti keel 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public EL = elliniká 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public EN = English 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public FR = français 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public IT = italiano 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public LV = latviešu valoda 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public LT = lietuvių kalba 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public HU = magyar 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public MT = Malti 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public NL = Nederlands 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public PL = polski 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public PT = português 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public RO = română 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public SK = slovenčina 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public SL = slovenščina 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public FI = suomi 2007-05-31 2010-10-20
DuoTrav : EPAR - Summary for the public SV = svenska 2007-05-31 2010-10-20

This EPAR was last updated on 22/03/2018 .

Authorisation details

Product details

Product details for DuoTrav
NameDuoTrav
Agency product numberEMEA/H/C/000665
Active substance

travoprost / timolol

International non-proprietary name (INN) or common name

travoprost / timolol

Therapeutic area Ocular HypertensionGlaucoma, Open-Angle
Anatomical therapeutic chemical (ATC) code S01ED51

Publication details

Publication details for DuoTrav
Marketing-authorisation holder

Novartis Europharm Limited

Revision15
Date of issue of marketing authorisation valid throughout the European Union24/04/2006

Contact address:

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

Product information

Product information

15/02/2018  DuoTrav -EMEA/H/C/000665 -II/0052

Name Language First published Last updated
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22
DuoTrav : EPAR - Product Information SV = svenska 2009-02-12 2018-03-22

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
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09
DuoTrav : EPAR - All Authorised presentations SV = svenska 2007-05-31 2015-02-09

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
DuoTrav : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-02-12 2018-03-22

Initial marketing-authorisation documents

Name Language First published Last updated
DuoTrav : EPAR - Procedural steps taken before authorisation SV = svenska 2007-05-31  
DuoTrav : EPAR - Scientific Discussion SV = svenska 2007-05-31  

Authorised

This medicine is approved for use in the European Union