PRO-DYNAM ORAL POWDER 1 G PHENYLBUTAZONE PER SACHET
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-05-2024
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Active ingredient:
PHENYLBUTAZONE
Available from:
Dechra Veterinary Products A/S
ATC code:
QM01AA01
INN (International Name):
PHENYLBUTAZONE
Dosage:
1 Grams
Pharmaceutical form:
Oral Powder
Prescription type:
POM
Therapeutic group:
Equine Non Food
Therapeutic area:
Phenylbutazone
Therapeutic indications:
N.S.A.I.D
Authorization status:
Authorised
Authorization date:
2000-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10803/001/001
Case No: 7006940
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
DECHRA VETERINARY PRODUCTS A/S
MEKUVEJ 9, DK-7171 ULDUM, DENMARK
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:
PRO-DYNAM ORAL POWDER, 1 G PHENYLBUTAZONE PER SACHET
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 12/11/2009.
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 13/11/2009_
_CRN 7006940_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pro-Dynam Oral Powder 1 g phenylbutazone per sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Each 5g sachet contains phenylbutazone 1 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White oral powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of musculoskeletal conditions in the horse where relief from pain
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