ATOPICA 50 MG SOFT CAPSULES FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
CICLOSPORIN
Available from:
Novartis Animal Health UK Ltd
ATC code:
QL04AA01
Dosage:
50 Milligram
Pharmaceutical form:
Capsules, Soft
Therapeutic group:
Miscellaneous
Therapeutic area:
Canine
Authorization date:
2009-06-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
10825/005/003
Case No: 7005491
Transferred from 10835/049/003.
The Irish Medicines Board in exercise of the powers conferred on it by the Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to: NOVARTIS ANIMAL HEALTH UK LTD
FRIMLEY BUSINESS PARK, FRIMLEY, SURREY GU16 7SR, ENGLAND
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
ATOPICA 50 MG SOFT CAPSULES FOR DOGS
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said schedule.
The authorisation,unless revoked, shall continue in force from 01/06/2009.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/06/2009_
_CRN 7005491_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ATOPICA 50 mg soft capsules for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ciclosporin
50.00 mg
EXCIPIENT(S):
-tocopherol (E-307)
0.50 mg
Titanium dioxide (E-171)
4.50 mg
Carminic acid (E-120)
< 1.00 ug
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule
Yellow-white oblong capsules bearing the following imprint: NVR and 50 mg.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Read the complete document
