WC500165698

Background
Colistimethate sodium is a cyclic polypeptide antibacterial agent indicated for the management of
chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6
years and older.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Colobreathe, a
centrally authorised medicine containing colistimethate sodium, and issued a recommendation on its
marketing authorisation(s).
Summary of recommendation(s) and conclusions
Based on the review of the data on safety and efficacy, the risk-benefit balance of Colobreathe
(colistimethate sodium) in the approved indication(s) remains favourable.
The current terms of the marketing authorisation(s) should be maintained.
In the next PSUR, the MAH should reflect the important identified risks (dyspnoea, lower
respiratory tract infection, dysgeusia) and potential risks (hepatotoxicity) as concluded in the
assessment of RMP version 4.
The next PSUR should be submitted in accordance with the requirements set out in the list of Union
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC.
The Rapporteur took the opportunity to inform the PRAC regarding an increased frequency of reporting
of capsule breakage (within the turbospin inhaler device). PRAC noted that the capsule breakage rate
is relatively low and that whilst this may have caused cough or dysgeusia in some patients, such
reactions are also known side effects of the product itself and there is no evidence of any serious
implications from capsule breakage. The PRAC considered that it would not be appropriate to set up a
registry to collect further data on the rate of capsule breakage at this stage but instead that the focus
should be on successfully addressing the root cause. Further assessment will be conducted at the level
of the CHMP and the PRAC will be consulted as applicable.
6.1.3. Crizotinib – XALKORI (CAP)
Evaluation of a PSUR procedure
Status: for discussion and agreement of recommendation to CHMP
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
Administrative details:
Procedure number(s): EMEA/H/C/002489/PSU 019
MAH(s): Pfizer Limited
Documents:
For adoption: PRAC PSUR AR, PRAC recommendation
Background
Crizotinib is a selective small-molecule inhibitor of the anaplastic lymphoma kinase (ALK) receptor
tyrosine kinase indicated for the treatment of adults with previously treated ALK-positive advanced
non-small cell lung cancer (NSCLC).
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 29/64