Dihydrostreptomycin 25% Solution for Injection

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Dihydrostreptomycin sulphate

MAH:

Alfasan Nederland B.V

ATC_code:

QJ01GA90

INN:

Dihydrostreptomycin sulphate

dosage:

25 percent weight/volume

pharmaceutical_form:

Solution for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Cattle

therapeutic_area:

dihydrostreptomycin

therapeutic_indication:

Antibacterial

authorization_status:

Authorised

authorization_date:

1988-10-01

SPC

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10980/004/001
Case No: 7005142
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:
ALFASAN INTERNATIONAL B.V.
KUIPERSWEG 9
,
3449 JA WOERDEN
,
WOERDEN 3440AB
,
NETHERLANDS
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:
DIHYDROSTREPTOMYCIN 25% SOLUTION FOR INJECTION
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 previously revoked, shall continue in force
from
30/09/2008
.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any
previous authorisation in respect of this product which is now null
and void.)
I
R
I
S
H
M
E
D
I
C
I
N
E
S
B
O
A
R
D
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_6_
_/_
_0_
_8_
_/_
_2_
_0_
_0_
_9_
_C_
_R_
_N_
_ _
_7_
_0_
_0_
_5_
_1_
_4_
_2_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dihydrostreptomycin 25% Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipien