1u7kf0g

The MAHs of nationally authorised medicines containing mycophenolic acid and their salts
including generic products should also submit within 60 days a variation to amend the product
information (in line with that of the reference product) to the national competent authorities of
the Member States.
For the full PRAC recommendations, see EMA/PRAC/337405/2014 published on the EMA website.
4.3.6. Vildagliptin – GALVUS (CAP), JALRA (CAP), XILIARX (CAP)
Vildagliptin, metformin – EUCREAS (CAP), ICANDRA (CAP), ZOMARIST (CAP)
Signal of interstitial lung disease
Regulatory details:
PRAC Rapporteur: Qun-Ying Yue (SE)
Administrative details:
EPITT 17793 – Follow-up February 2014
MAH(s): Novartis Europharm Ltd
Background
For background information, see PRAC minutes of 3-6 February 2014.
The MAH replied to the request for information on the signal interstitial lung disease and the responses
were assessed by the Rapporteur.
Discussion
The PRAC discussed the assessment of the review of the signal including published literature, postmarketing
and clinical trial data. Several of the clinical trial cases had confounding factors, and
therefore it was difficult to draw any firm conclusions from the clinical trial data.
Many of the cases reported were confounded by the patient’s medical history and/or concomitant
medication (e.g. statins) that could provide an alternative explanation for the development of the
reaction; or an infectious aetiology was suspected. However a causal role of vildagliptin could not be
excluded in a number of cases, due to a plausible temporal relationship the fact that there was no
effect of antibiotic treatment, and recovery upon discontinuation of vildagliptin and steroid treatment.
Therefore the PRAC agreed that it was appropriate to include interstitial lung disease in the product
information.
Summary of recommendation(s)
The MAHs for the reference, centrally authorised 16 vildagliptin containing medicines should be
requested to submit to the EMA within 60 days a variation to update the product information to
include “interstitial lung disease” 17 as an undesirable effect.
For the full PRAC recommendations, see EMA/PRAC/337405/2014 published on the EMA website.
16 In line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, the marketing
authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge
including the conclusions of the assessment and recommendations made public by means of the European medicines webportal
established in accordance with Article 26 of Regulation (EC) No 726/2004 (EMA website). For nationally authorised
medicines, it is the responsibility of the National Competent Authorities of the Member States to oversee that these
recommendations are adhered to
17 Section 4.8 of the Summary of Product Characteristics and package leaflet
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 23/75