THYROXYL 0.5 MG TABLET
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-06-2024
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Active ingredient:
LEVOTHYROXINE SODIUM
Available from:
Dechra Ltd
ATC code:
QH03
Dosage:
0.5 Milligram
Pharmaceutical form:
Tablets
Therapeutic group:
Hormone
Therapeutic area:
Canine
Authorization date:
2007-04-27
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007
(S.I. NO. 144 OF 2007)
VPA:10799/006/004
Case No: 7002179
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to:
DECHRA LTD
DECHRA HOUSE, JAMAGE INDUSTRIAL ESTATE, TALKE PITS, STOKE-ON-TRENT, STAFFORDSHIRE ST7 1XW, UNITED KINGDOM
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:
THYROXYL 0.5 MG TABLET
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 Part 2 of the said Schedule.
This authorisation,unless previously revoked, shall continue in force from 27/04/2007 to 26/04/2012.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 03/05/2007_
_CRN 7002179_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Thyroxyl 0.5 mg Tablet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Levothyroxine Sodium 0.50 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Small elliptical white tablets.
Scored on the face of each tablet with the strength in milligrams to the right.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the long term treatment of thyroid insufficiency in dogs.
4.3 CONTRAINDICATIONS
Do not use in animals with known
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