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.
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
Sep 16, 2016 - Send a question via our website www.ema.europa.eu/contact ... Name of medicine. INN ... in patients with HCV/HBV co-infection are available.
Sep 16, 2016 - PSUR assessment resulting in an update of section 2 of the Package Leaflet to include references to methadone and buprenorphine (already mentioned in the SmPC) as examples of opioid substances that are contraindicated. This update was
Nov 9, 2017 - be based only on the scientific data available when the Committee ... Article 34(1) and (2) of Regulation (EC) No 726/2004 shall apply to the ...
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