Bivalirudin Cipla
lAkemedelsverket
MEDICAL PRODUCTS AGENCY
Summary Public Assessment Report
Bivalirudin Cipla (bivalirudin)
SE/H/1497/01/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
Bivalirudin Cipla (bivalirudin)
Powder for concentrate for solution for injection or infusion; 250 mg
This is a summary of the public assessment report (PAR) for Bivalirudin Cipla. It explains how Bivalirudin 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 Bivalirudin Cipla.
For practical information about using Bivalirudin Cipla, patients should read the package leaflet or contact their doctor or pharmacist.
What is Bivalirudin Cipla and what is it used for?
Bivalirudin Cipla is a ‘generic medicine’. This means that Bivalirudin Cipla is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Angiox.
Bivalirudin Cipla is used to treat patients:
• with chest pain due to heart disease (acute coronary syndromes - ACS);
• who are having surgery to treat blockages in their blood vessels (angioplasty and/or percutaneous coronary intervention - PCI).
How does Bivalirudin Cipla work?
Bivalirudin Cipla contains a substance called bivalirudin which is an antithrombotic medicine. Antithrombotics are medicines which prevent the formation of blood clots (thrombosis).
How is Bivalirudin Cipla used?
The pharmaceutical form of Bivalirudin Cipla is powder for concentrate for solution for injection/ infusion.
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 Bivalirudin Cipla have been shown in studies?
No additional studies were needed as Bivalirudin Cipla is a generic medicine that is given by infusion/intravenous injection and contains the same active substance as the reference medicine, Angiox.
What are the possible side effects of Bivalirudin Cipla?
Because Bivalirudin Cipla is a generic 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 Bivalirudin Cipla approved?
It was concluded that, in accordance with EU requirements, Bivalirudin Cipla has been shown to have comparable quality and to be similar to the reference medicine Angiox. Therefore, the Medical Products Agency in Sweden decided that, as for Angiox, 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 Bivalirudin Cipla?
A risk management plan has been developed to ensure that Bivalirudin 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 Bivalirudin 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 Bivalirudin Cipla
The marketing authorisation for Bivalirudin Cipla was granted on 2016-08-24 in Sweden.
The full PAR for Bivalirudin Cipla can be found on the following website: http://mri.medagencies.org/Human/. For more information about treatment with Bivalirudin Cipla, please read the package leaflet or contact your doctor or pharmacist.
This summary was last updated in 2016-08.