Pro-Dynam Oral Powder 1 g phenylbutazone per sachet

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Phenylbutazone

Saadav alates:

Dechra Veterinary Products A/S

ATC kood:

QM01AA01

INN (Rahvusvaheline Nimetus):

Phenylbutazone

Annus:

1.0 g/sachet

Ravimvorm:

Oral powder

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Non food-producing horses

Terapeutiline ala:

phenylbutazone

Näidustused:

N.S.A.I.D.

Volitamisolek:

Authorised

Loa andmise kuupäev:

2000-10-01

Toote omadused

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.)
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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
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