CVMP opinions on veterinary medicinal products
Under Regulation (EU) 2019/6
The Committee adopted by consensus a positive opinion for a
marketing authorisation application
for
Brucellin Aquilon
(
Brucella abortus
), from Aquilon Cyl S.L., a new product for
in vivo
diagnosis of
Brucella
infected pigs (skin test) to discriminate false positive results by
Brucella
serological tests.
The Committee adopted by consensus a positive opinion for a
variation
requiring assessment for
Porcilis PCV ID
(subject to
worksharing
procedure), concerning the update of the
product information
of Porcilis PCV ID to include new associated use combinations of Porcilis PCV ID, Porcilis Lawsonia ID, Porcilis M Hyo ID ONCE and Porcilis PRRS.
The Committee adopted by consensus a positive opinion for a grouped
variation
requiring assessment for
Simparica Trio
, concerning the addition of three new therapeutic
indications
: for the treatment of sarcoptic mange (caused by
Sarcoptes scabiei
var.
canis
), for the treatment of demodicosis (caused by
Demodex canis
), and for the prevention of establishment of thelaziosis (adult
Thelazia callipaeda
eyeworm infection).
The Committee adopted by consensus a positive opinion for a
variation
requiring assessment for
Credelio Plus
, concerning the addition of a new therapeutic
indication
for the treatment of demodicosis (caused by
Demodex canis
).
The Committee adopted by consensus a positive opinion for a grouped
variation
requiring assessment for
NexGard
and
Nexgard Spectra
, subject to
worksharing
procedure, concerning the addition of two new therapeutic
indications
for the treatment of tick infestations with
Hyalomma marginatum
and for the treatment of ear mite infestations (caused by
Otodectes cynotis
), and to amend the
product information
to allow the use of the products in breeding, pregnant and lactating female dogs.
The Committee adopted by consensus a positive opinion for a
variation
requiring assessment for
Prevomax
to align the
product information
with version 9.0 of the QRD template.
The Committee adopted by consensus positive opinions for
variations
requiring assessment concerning quality-related changes for :
Locatim
Solensia
Purevax RC, Purevax RCP FeLV, Purevax RCPCh FeLV, BTVPUR, Eurican Herpes 205, Purevax RCPCh
and
Purevax RCP
(subject to
worksharing
procedure)
Suvaxyn CSF Marker, Fevaxyn Pentofel
and
Suvaxyn PRRS MLV
(subject to
worksharing
procedure)
Mirataz
Imoxat
Panacur Aquasol
(subject to
worksharing
procedure)
Procox
(2 procedures)
Bluevac BTV
Union referrals and related procedures
The Committee concluded the
referral
procedure for
veterinary
medicinal products
containing
N-methyl pyrrolidone as an
excipient
.
The matter was referred to the Committee by Germany under Article 82 of Regulation (EU) 2019/6 due to concerns relating to the appropriateness of user and target animal safety warnings in view of the teratogenic potential of N-methyl pyrrolidone. The Committee concluded that no changes need to be made in the
product information
for some of the veterinary
medicinal products
concerned by this
referral
. Furthermore, the Committee agreed that user and/or target animal safety warnings should be added to the
product information
of the remaining products concerned. The Committee adopted by consensus an opinion concluding that the benefit-risk balance of the concerned products remains favourable and that the
marketing authorisations
should be maintained or varied, as applicable.
Scientific advice
The Committee adopted two
scientific advice
reports further to requests for initial advice concerning one immunological product for piglets and a substance intended for inclusion in the list of substances considered as not falling within the scope of Regulation No 470/2009.
The Committee endorsed one clarification of a
scientific advice
concerning a pharmaceutical product for mice, rats, hamsters, gerbils, guinea pigs, chinchillas and rabbits.
Pharmacovigilance
Under Regulation (EU) 2019/6
The Committee adopted recommendations for changes to the
summary of product characteristics
for
Bravecto
,
Proteq West Nile
,
Procox
,
Zuprevo
,
Felpreva
and
Improvac
as outcome of signal detection activities.
Concept papers, guidelines and SOPs
Environmental Risk Assessment
The Committee adopted a draft
reflection paper
on the
environmental risk assessment
of ectoparasiticidal veterinary
medicinal products
used in
cats
and dogs (EMA/
CVMP
/ERA/31905/2022) for a 3-month period of public consultation. This
reflection paper
has been developed to communicate the
CVMP
's view on the scientific discussion regarding the potential environmental impact(s) of ectoparasiticidal veterinary
medicinal products
used in
cats
and dogs, and provides an opportunity for stakeholders to contribute their views.
Efficacy
The Committee adopted a Questions and answers document on the ‘
Guideline
on the
summary of product characteristics
for antiparasitic veterinary
medicinal products
' (EMA/
CVMP
/EWP/799840/2022).
Quality
The Committee adopted a draft
concept paper
on a
guideline
on risk management requirements for elemental impurities in veterinary
medicinal products
, including immunological veterinary
medicinal products
(EMA/
CVMP
/637041/2022) for a 3-month period of public consultation.
The Committee adopted a revised
reflection paper
on the definition of new
active substance
status - Veterinary (EMA/
CVMP
/QWP/3629/2016). This
reflection paper
has been revised to align to Regulation (EU) 2019/6.
The Committee adopted the following revised
guidelines
(GL) to align to Regulation (EU) 2019/6:
GL on development pharmaceutics for veterinary
medicinal products
(EMA/
CVMP
/QWP/684556/2022)
GL on chemistry of
active substance
veterinary (EMA/
CVMP
/QWP/707366/2017)
GL on control of impurities of pharmacopoeial substances (EMA/
CVMP
/QWP/907965/2022)
GL on parametric release (EMA/
CVMP
/QWP/339588/2005)
GL on declaration of storage conditions (EMA/
CVMP
/QWP/857608/2022)
GL on stability of existing
active substance
and related finished product (EMA/
CVMP
/QWP/709423/2022)
GL on additional quality requirements for products intended for incorporation into animal feed (EMA/
CVMP
/QWP/711629/2022)
GL on quality of single-dose spot-on products (EMA/
CVMP
/QWP/544461/2007)
GL on quality of modified release oral dosage forms - veterinary (EMA/
CVMP
/QWP/908160/2022).
Working parties
The Committee adopted the work plans for 2023 for the
CVMP
Working Parties on Antimicrobials (EMA/
CVMP
/AWP/715896/2022),
Environmental Risk Assessment
(EMA/
CVMP
/ERA/828487/2022),
Efficacy
(EMA/
CVMP
/EWP/817611/2022), Novel Therapies and Technologies (EMA/
CVMP
/NTWP/701391/2022),
Pharmacovigilance
(EMA/
CVMP
/PhVWP/593990/2022),
Scientific Advice
(EMA/
CVMP
/SAWP/827784/2022), and Joint
CHMP
/
CVMP
Quality
Working Party
, which will be published on the Agency’s website.
Cooperation with other EU agencies
The Committee adopted a report, prepared in collaboration with EFSA, on the development of a harmonised approach on exposure assessment methodologies for residues from VMPs, feed additives and pesticides in food of animal origin following close of public consultation.
Organisational matters
The Committee adopted the
CVMP
work plan for 2023 (EMA/
CVMP
/617330/2022).
More information about the above-mentioned medicines (including their full
indications
),
guidelines
,
reflection papers
, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”.