NEXGARD COMBO Solution

Pays: Canada

Langue: français

Source: Health Canada

Ingrédients actifs:

Ésafoxolaner; Éprinomectine; Praziquantel

Disponible depuis:

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.

Dosage:

1.2%; 0.4%; 8.3%

forme pharmaceutique:

Solution

Composition:

Ésafoxolaner 1.2%; Éprinomectine 0.4%; Praziquantel 8.3%

Mode d'administration:

Topique

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Groupe thérapeutique:

Chats

Descriptif du produit:

Numéro de groupe d'ingrédients actifs (GIA) :0362724001

Statut de autorisation:

APPROUVÉ

Date de l'autorisation:

2021-01-22

Notice patient

Page 1 of 2
VETERINARY DRUGS DIRECTORATE
Health Products and Food Branch
Ottawa ON
Website:
https://www.canada.ca/en/health-canada/services/drugs-health-products/veterinary-drugs.html
THIS COMMUNICATION IS SOLELY FOR THE INTENDED RECIPIENT. IF YOU
RECEIVED THIS IN ERROR, PLEASE ADVISE THE SENDER
IMMEDIATELY. DISCLOSURE, COPY, USE OR DISTRIBUTION OF THE INFORMATION
IN THIS MESSAGE IS PROHIBITED.
TO:
Name/Title:
Ms. Mona Ismail / Regulatory Affairs Associate
Organization:
Boehringer Ingelheim Animal Health Canada Inc.
Date:
April 26, 2022
Email:
[e-mail] Tel:
905-631-4514
No. of Pages,
including this page
2
FROM:
Name:
Simon Adam
Title:
Senior Regulatory Affairs Officer
Submission and Knowledge Management Division (SKMD)
Email:
[e-mail]
Tel:
613-796-3061
CLARIFICATION REQUEST # 1
SKMD
Product Name
NexGard COMBO
DSTS Number
263428
Submission Type
Supplemental New Drug Submission
In accordance with the Guidance Document on Management of Regulatory
Submissions, effective November 12,
2021, responses to the following comment(s) are requested to allow
continued evaluation of the above-noted
submission.
Page 2 of 2
GENERAL
1.
Please note that your current SNDS was considered administratively
complete as of April 14
th
, 2022, and
consequently the review fees for the current year cycle (April 1
st
, 2022 – March 31
st
, 2023) are applicable.
You are therefore requested to revise accordingly the Veterinary Drug
Submission Application and Fee
Form, which was provided under part 1.6 of your initial submission,
and to resubmit it to us. A link to the
current form is provided below, for your convenience:
https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/funding-
fees/veterinary-drugs/veterinary-drug-submission-application-and-fee-form-eng-final-april-1-2022.pdf
The comment(s) outlined above should be addressed WITHIN 7 CALENDAR
DAYS OF THE DATE OF THIS CLARIFICATION
REQUEST, _i.e. _BY MAY 3, 2022. If the requested information is not
received within 7 ca