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Summary Public Assessment Report
non-generics
Bimatoprost/Timolol Sandoz 0.3 mg/ml + 5 mg/ml eye drops, solution
(bimatoprost/timolol)
NL/H/3805/001/DC
Date: 25 September 2017
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non-generics
Bimatoprost/Timolol Sandoz 0.3 mg/ml + 5 mg/ml eye drops, solution
Active substances: bimatoprost and timolol
This is a summary of the public assessment report (PAR) for Bimatoprost/Timolol Sandoz 0.3 mg/ml + 5 mg/ml eye drops, solution. It explains how Bimatoprost/Timolol Sandoz was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use Bimatoprost/Timolol Sandoz.
For practical information about using Bimatoprost/Timolol Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
What is Bimatoprost/Timolol Sandoz and what is it used for? Bimatoprost/Timolol Sandoz is a ‘hybrid generic medicine’. This means that it is similar to a reference medicine containing the same active substance. The reference medicine is Ganfort 0.3 mg/ml + 5 mg/ml eye drops, solution. Both products are given locally and act locally. The amount of active substance cannot be measured in the blood to directly compare Bimatoprost/Timolol Sandoz with Ganfort. When this is the case, the term ‘hybrid’ is used. Similarity is shown based on qualitative attributes of the two products.
Bimatoprost/Timolol Sandoz 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.
How does this medicine work? Raised pressure in the eye 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, Bimatoprost/Timolol Sandoz reduces the risk of damage. Bimatoprost/Timolol Sandoz contains two active substances, bimatoprost and timolol, which lower the pressure in the eye in different ways. Bimatoprost is a prostaglandin analogue (a copy of the natural substance prostaglandin), that works by increasing the drainage of fluid out of the eye. Bimatoprost on its own has already been approved in the European Union under the name Ganfort. Timolol is a beta- blocker that works by reducing the production of fluid within the eye. Timolol has been commonly used to treat glaucoma since the 1970s. The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
How is this medicine used? The pharmaceutical form of Bimatoprost/Timolol Sandoz is an eye drop solution and the route of administration is ocular (in the eye). Bimatoprost/Timolol Sandoz is given as one drop in the affected eye(s) once a day, either in the morning or the evening. It should be given at the same time each day. If more than one type of eye drop is being used, each one should be given at least five minutes apart.
Please read section 3 of the PL for detailed information on dosing recommendations, the route of administration, and the duration of treatment.
The medicine can only be obtained with a prescription.
How has this medicine been studied? Because Bimatoprost/Timolol Sandoz is a hybrid application and is considered to be therapeutically equivalent, to the reference product Ganfort, their benefits and risks are taken as being the same as those of the reference medicine.
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What are the possible side effects from this medicine? The most common side effect with Bimatoprost/Timolol Sandoz (which may affect more than 1 in 10 people) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye).
For the full list of restrictions, see the package leaflet.
Why is this medicine approved? The Medicines Evaluation Board decided that Bimatoprost/Timolol Sandoz’s benefits are greater than its risks and recommended that it be approved for use.
What measures are being taken to ensure the safe and effective use of Bimatoprost/Timolol Sandoz? A risk management plan has been developed to ensure that Bimatoprost/Timolol Sandoz 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 Bimatoprost/Timolol Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well.
Other information about Bimatoprost/Timolol Sandoz The marketing authorisation for Bimatoprost/Timolol Sandoz 0.3 mg/ml + 5 mg/ml eye drops, solution was granted on 10 August 2017.
The full PAR for Bimatoprost/Timolol Sandoz can be found on the website http://mri.cts- mrp.eu/Human/. For more information about treatment with Bimatoprost/Timolol Sandoz, read the package leaflet (https://mri.cts-mrp.eu/Human/Downloads/NL_H_3805_001_FinalPL.pdf) or contact your doctor or pharmacist.
This summary was last updated in September 2017.
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