Valganciclovir Cipla
lAkemedelsverket
MEDICAL PRODUCTS AGENCY
Summary Public Assessment Report
Valganciclovir Cipla (valganciclovir hydrochloride)
SE/H/1525/01/DC
Postadress/Postal address: P.O. Box 26, SE-751 03 Uppsala, SWEDEN Besoksadress/Visiting address: Dag Hammarskjolds vag 42, Uppsala Telefon/Phone: +46 (0)18 17 46 00 Fax: +46 (0)18 54 85 66 Internet: www.lakemedelsverket.se E-mail: registrator@mpa.se
Summary Public Assessment Report
Valganciclovir Cipla (valganciclovir hydrochloride)
Film-coated tablets, 450 mg
This is a summary of the public assessment report (PAR) for Valganciclovir Cipla. It explains how Valganciclovir Cipla 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 Valganciclovir Cipla.
For practical information about using Valganciclovir Cipla, patients should read the package leaflet or contact their doctor or pharmacist.
What is Valganciclovir Cipla and what is it used for?
Valganciclovir Cipla is a ‘generic medicine’. This means that Valganciclovir Cipla is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Valcyte.
Valganciclovir Cipla is used in the treatment and prevention of cytomegalovirus (CMV) infections.
How does Valganciclovir Cipla work?
Valganciclovir belongs to a group of medicines, which work directly to prevent the growth of viruses.
How is Valganciclovir Cipla used?
The pharmaceutical form of Valganciclovir Cipla is film-coated tablet (e.g. oral use).
Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment.
The medicine can only be obtained with a prescription.
What benefits of Valganciclovir Cipla have been shown in studies?
Because Valganciclovir Cipla is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Valcyte. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the possible side effects of Valganciclovir Cipla?
Because Valganciclovir Cipla is a generic medicine and is bioequivalent to the reference medicine, its benefits and possible side effects are taken as being the same as the reference medicine. For the full list of restrictions, see the package leaflet.
Why is Valganciclovir Cipla approved?
It was concluded that, in accordance with EU requirements, Valganciclovir Cipla has been shown to have comparable quality and to be bioequivalent to the reference medicine Valcyte. Therefore, the Medical Products Agency in Sweden decided that, as for Valcyte, the benefits are greater than its risks and recommended that it can be approved for use.
What measures are being taken to ensure the safe and effective use of Valganciclovir Cipla?
A risk management plan has been developed to ensure that Valganciclovir Cipla 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 Valganciclovir Cipla, 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 Valganciclovir Cipla
The marketing authorisation for Valganciclovir Cipla was granted on 2016-07-20 in Sweden.
The full PAR for Valganciclovir Cipla can be found on the following website: http://mri.medagencies.org/Human/. For more information about treatment with Valganciclovir Cipla, please read the package leaflet or contact your doctor or pharmacist.
This summary was last updated in 2016-07.