Carboplatin Cipla
LAKEMEDELSVERKET
MEDICAL PRODUCTS AGENCY
Public Assessment Report Scientific discussion
Carboplatin Cipla (carboplatin)
SE/H/1425/01/DC
Asp no. 2014-0305
This module reflects the scientific discussion for the approval of Carboplatin Cipla. The procedure was finalised on 210. For information on changes after this date please refer to the module ‘Update’.
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.mpa.se E-mail: registrator@mpa.se
INTRODUCTION
I.
The application for Carboplatin Cipla, 10 mg/ml, concentrate for solution of infusion, is a generic application made according to Article 10(1) of Directive 2001/83/EC. The applicant, Cipla Europe NV, applies through the Decentralised Procedure with Sweden acting as reference member state (RMS) and AT, BE, DE, IE, MT and RO as concerned member states (CMS).
The reference medicinal product chosen for the purposes of establishing the expiry of the data protection period is Paraplatin, 10 mg/ml, concentrate for solution for infusion, authorised in Sweden in 1989, with Bristol-Myers Squibb AB as marketing authorisation holder. The marketing authorisation was withdrawn in 2010.
For approved indications, see the Summary of Product Characteristics.
For recommendations to the marketing authorisation not falling under Article 21a/22 of Directive 2001/83 and conditions to the marketing authorisation pursuant to Article 21a or 22 of Directive 2001/83/EC to the marketing authorisation, please see section VI.
II. QUALITY ASPECTS
11.1 Drug Substance
The structure of the drug substance has been adequately proven and its physico-chemical properties are sufficiently described.
The manufacture of the drug substance has been adequately described and satisfactory specifications have been provided for starting materials, reagents and solvents.
The drug substance specification includes relevant tests and the limits for impurities and degradation products have been justified. The analytical methods applied are suitably described and validated.
Stability studies confirm the retest period.
11.2 Medicinal Product
The medicinal product is formulated using excipients listed in section 6.1 in the Summary of Product Characteristics.
The manufacturing process has been sufficiently described and critical steps identified.
The tests and limits in the specification are considered appropriate to control the quality of the finished product in relation to its intended purpose.
Stability studies have been performed and data presented support the shelf life and special precautions for storage claimed in the Summary of Product Characteristics, sections 6.3 and 6.4.
NON-CLINICAL ASPECTS
III.
III.1 Discussion on the non-clinical aspects
Since this product has been shown to be essentially similar and refer to a product approved based on a full application with regard to preclinical data, no further such data have been submitted or are considered necessary.
IV. CLINICAL ASPECTS
IV.1 Pharmacokinetics
No studies have been conducted. The applied product is to be administered as an aqueous intravenous solution containing the same active substance as the currently authorised product. For this type of product, bioequivalence studies are not required according to the Guideline on the investigation of Bioequivalence (CHMP/QWP/EWP/1401/98 Rev. 1).
IV.2 Discussion on the clinical aspects
Since this product has been shown to be essentially similar and refer to a product approved based on a full application with regard to clinical efficacy/safety data, no further such data have been submitted or are considered necessary.
IV.3 Risk Management Plan
The MAH has submitted a risk management plan, in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Carboplatin Cipla.
Safety specification
Summary table of safety concerns as approved in RMP
|
Important identified risks |
• Hypersensitivity and anaphylaxis • Myelosuppression • Use in pre-existing severe renal impairment and nephrotoxity • Concurrent therapy with nephrotoxic drugs or ototoxic drugs • Haemorrhagic complications • Pulmonary fibrosis • Neurotoxicity (peripheral neuropathies) • Severe hepatic dysfunction including acute liver necrosis • Ototoxic |
|
Important potential risks |
• Cardiac failure, embolism • Secondary malignancies • Overdose |
|
Missing information |
• Use in Pediatric population • Use in pregnancy • Use in breast-feeding |
Pharmacovigilance Plan
Routine pharmacovigilance is suggested and no additional pharmacovigilance activities are proposed by the applicant, which is endorsed.
Risk minimisation measures
Routine risk minimisation is suggested and no additional risk minimisation activities are proposed by the applicant, which is endorsed.
Summary of the RMP The RMP is approved
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
- At the request of the RMS;
- Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time, but via different procedures.
V. USER CONSULTATION
The package leaflet has been evaluated via a user consultation study in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for the purpose of user testing the PIL was English.
The results show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use.
VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION
The benefit/risk ratio is considered positive and Carboplatin Cipla, 10 mg/ml, concentrate for solution of infusion, is recommended for approval.
List of recommendations not falling under Article 21a/22 of Directive 2001/83 in case of a positive benefit risk assessment
N/A
List of conditions pursuant to Article 21a or 22 of Directive 2001/83/EC
N/A
VII. APPROVAL
Products approved in the MR/DCPprocedure:
The Mutual recognition/Decentralised procedure for Carboplatin Cipla, 10 mg/ml, concentrate for solution of infusion, was positively finalised on 2015-12-16.
LAKEMEDELSVERKET
MEDICAL PRODUCTS AGENCY
Public Assessment Report - Update
|
Scope |
Procedure number |
Product Information affected |
Date of start of the procedure |
Date of end of procedure |
Approval/ non approval |
Assessment report attached |
|
Y/N (version) |
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.mpa.se E-mail: registrator@mpa.se
Template version: 2015-06-23