Argentina - Drug Information Association

European Union - CMDh/199/2011: CMD(h) Summary of Activities 2010, Jan-
2011
For transparency reasons, the CMD(h) has agreed to publish a summary of the main activities carried out by the CMD(h)
and its sub-groups/working groups in 2010. This summary covers the following topics: - Introduction - General Information
- Workplan 2010 - Summary - CMDh activities in 2010 - MRP/DCP Statistics A list of the new and revised CMD(h)
documents and questions & answers published by the CMD(h) in 2010 is also included as Annex to this document.
Document date: Jan-2011
Type of text: Report
Regulatory version: None
Language: English
European Union - EMA/CHMP/55372/2011: 74th Plenary Meeting Monthly
Report of the CHMP from 17/20-Jan-2011
This is the monthly report for the 74th meeting of the CHMP, held on 17/20-Jan-2011. During this meeting several issues
were discussed, among which: - Centralised procedure - Post-authorisation procedures - Other information on the
centralised procedure - Referral procedures - Mutual-recognition and decentralised procedures - Human - CHMP working
parties - Upcoming meetings following the December 2010 CHMP plenary meeting - Organisational matters This report also
contains various annexes which include the following information: - Medicinal products granted a community marketing
authorisation under the centralised procedure since the December 2010 CHMP Monthly Report - Pre-authorisation: scientific
advice and protocol assistance EMA centralised procedures - Documents adopted during the January 2011 CHMP meeting
Comment: The next CHMP meeting will take place on 14/17-Feb-2011.
Document date: 28-Jan-2011
Type of text: Report
Regulatory version: None
Language: English
European Union - EMA/CHMP/PhVWP/51040/2011: Pharmacovigilance Working
Party (PhVWP) - January 2011 Plenary Meeting, 27-Jan-2011
The CHMP Pharmacovigilance Working Party (PhVWP) held its January plenary meeting on 17/19-Jan-2011. During this
meeting, one topic on safety concerns were discussed: insulin products - consistent product information regarding the risk
of heart failure with concomitant use of pioglitazone.
Document date: 27-Jan-2011
Type of text: Report
Regulatory version: None
Language: English
European Union - EMEA/H/C/001103: Withdrawal Assessment Report for
CEREPRO (sitimagene ceradenovec), Feb-2011.
This document provides the Withdrawal Assessment Report for CEREPRO (sitimagene ceradenovec). - CEREPRO is indicated
for use in conjunction with ganciclovir sodium for the treatment of patients with operable high grade glioma. Reasons for
Withdrawal: - During the meeting on 17 December 2009, the CHMP, in the light of the overall data submitted, based on the
CAT opinion and the scientific discussion within the Committee, issued a negative opinion for granting a Marketing
Authorisation to CEREPRO on 17 December 2009. - The benefit-risk of CEREPRO for use in conjunction with ganciclovir
sodium for the treatment of patients with operable high-grade glioma is not positive for the following grounds: - The
efficacy data submitted do not demonstrate the benefit of CEREPRO in the claimed indication. The primary efficacy analysis
did not show any statistically and clinically significant difference between the active treatment and the control arm; in this
failed trial any post-hoc subgroup analyses can only be considered as exploratory. - In addition, during this open label trial,
the company changed the primary endpoint in a sequential design from ‘overall survival’ to “time to death or reintervention”,
which is prone to bias by treating physicians. - The administration of CEREPRO is associated with an increased
incidence of adverse events and of serious adverse events (e.g. hemiparesis, seizures). In view of the lack of proven
efficacy of CEREPRO and the risk management submitted, the documented side effects result in a negative benefit/risk
ratio. - Due to the aforementioned concerns a satisfactory summary of product characteristics, risk management plan,
environmental risk assessment and follow-up measures to address other concerns as outlined in the list of outstanding
issues cannot be agreed at this stage. - Applicant: Ark Therapeutics Ltd.
Comment: This document should be read in conjunction with the Questions and Answer document (105378) on the
withdrawal of the application: the Assessment Report may not include all available information on the product if the CHMP
assessment of the latest submitted information was still ongoing at the time of the withdrawal of the application.
Document date: Feb-2011
Type of text: Report
Regulatory version: None
Language: English