24 June 2016 EMA/76609/2016 Press office

Opinions on safety variations/PSURs Adopted at the CHMP meeting of 20-23 June 2016

Name of medicine

INN

Scope

Benlysta

belimumab

CHMP opinion to update of section 4.4 of the SmPC in order to add information on effect of Benlysta on vaccine responses based on results from study BEL115470 (HGS1006-C1117).

Halaven

eribulin

PSUR resulting in an update of section 4.8 of the SmPC to add Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) as adverse reactions with frequency “not known”.

Jakavi

ruxolitinib

CHMP opinion to update sections 4.2 and 4.5 of the SmPC in order to include information that the concomitant use of Jakavi with fluconazole doses greater than 200 mg daily should be avoided.

Ketoconazole HRA

ketoconazole

PSUR assessment resulting in an update to section 4.5 of the SmPC on interactions with crizotinib, ibrutinib and the direct-acting antiviral (DAAV) combination of ombitasvir-paritaprevir-ritonavir. Section 4.3 of the SmPC was also updated to include contraindication with the use of the DAAV combination of ombitasvir-paritaprevir-ritonavir.

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An agency of the European Union

Name of medicine

INN

Scope

Mekinist

trametinib

PSUR assessment resulting in an update of the existing SmPC 4.4 warnings on left ventricular ejection fraction (LVEF) reduction/left ventricular dysfunction, and update of section 4.8 of the SmPC to add the adverse reaction myocarditis with a frequency unknown for trametinib and dabrafenib combination therapy.

Noxafil

posaconazole

CHMP opinion to update of section 4.2 of the SmPC in order to strengthen the information about noninterchangeability of the oral formulations based on new reports of medication errors related to confusion between posaconazole tablets and oral suspension in prescribing.

Olysio

simeprevir

PSUR assessment resulting in an update of section 4.8 of the SmPC to add information about hepatic failure symptoms in patients at risk of hepatic decompensation and failure with the use of simeprevir.

Renagel, Renvela,

sevelamer

Sevelamer carbonate

PSUSA assessment resulting in an update of section 4.4 to add a warning regarding gastrointestinal disorders associated with sevelamer crystals.

Zentiva, Tasermity

Vargatef

nintedanib

PSUR assessment resulting in an update of section 4.4 and 4.8 of the SmPC to add a warning on “gamma-glutamyltransferase increased”, and to add the adverse reaction “gamma-glutamyltransferase increased” with a frequency “common”.

Xalkori

crizotinib

CHMP opinion to update section 4.4 and 4.8 of the SmPC with regards to the effect of crizotinib on renal function following a retrospective review of renal safety data from clinical studies A8081014 (1014), A8081007, (1007), A8081005 (1005), and A8081001 (1001).

Cancidas

caspofungin

CHMP opinion to update of sections 4.4, 4.8 of the SmPC in order to add warning on serious cutaneous reactions and to include the new ADRs “toxic epidermal necrolysis” and “Stevens-Johnson Syndrome” with the frequency ‘not known’ based on the post-marketing experience.

Opinions on safety variations/PSURs EMA/76609/2016

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Opinions on safety variations/PSURs June 2016 - European ...

Jun 24, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ... Name of medicine. INN. Scope. Benlysta.

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