Carboplatin Cipla
LAKEMEDELSVERKET
MEDICAL PRODUCTS AGENCY
Summary Public Assessment Report
Carboplatin Cipla (carboplatin)
SE/H/1425/01/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
Carboplatin Cipla (carboplatin)
concentrate for solution of infusion
This is a summary of the public assessment report (PAR) for Carboplatin Cipla. It explains how Carboplatin 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 Carboplatin Cipla.
For practical information about using Carboplatin Cipla, patients should read the package leaflet or contact their doctor or pharmacist.
What is Carboplatin Cipla and what is it used for?
Carboplatin Cipla is a ‘generic medicine’. This means that Carboplatin Cipla is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Paraplatin.
Carboplatin Cipla contains carboplatin, which belongs to a group of medicines known as platinum coordination compounds, which are used to treat cancer.
Carboplatin Cipla is used against advanced cancer of the ovary and small cell cancer of the lung.
How does Carboplatin Cipla work?
Carboplatin is an antineoplastic agent. Its activity has been demonstrated against several murine and human cell lines.
Carboplatin exhibited comparable activity to cisplatin against a wide range of tumours regardless of implant site.
Alkaline elution techniques and DNA binding studies have demonstrated the qualitatively similar modes of action of carboplatin and cisplatin. Carboplatin, like cisplatin, induces changes in the superhelical conformation of DNA, which is consistent with a "DNA shortening effect".
How is Carboplatin Cipla used?
The pharmaceutical form of Carboplatin Cipla is concentrate for solution of infusion for intravenous use only.
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 Carboplatin Cipla have been shown in studies?
No additional studies were needed as Carboplatin Cipla is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Paraplatin.
What are the possible side effects of Carboplatin Cipla?
Because Carboplatin 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 Carboplatin Cipla approved?
It was concluded that, in accordance with EU requirements, Carboplatin Cipla has been shown to have comparable quality and to be similar to the reference medicine Paraplatin. Therefore, the Medical Products Agency in Sweden decided that, as for Paraplatin, 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 Carboplatin Cipla?
A risk management plan has been developed to ensure that Carboplatin 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 Carboplatin 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 Carboplatin Cipla
The marketing authorisation for Carboplatin Cipla was granted on 2015-12-16 in Sweden.
The full PAR for Carboplatin Cipla can be found on the following website: http://mri.medagencies.org/Human/. For more information about treatment with Carboplatin Cipla, please read the package leaflet or contact your doctor or pharmacist.
This summary was last updated in 2016-01.