PULSATYL SDK Film Coated Tablet 100 mg

국가: 탄자니아

언어: 영어

출처: Tanzania Medicinces & Medical Devices Authority

유효 성분:

Metoprolol

제공처:

ILKO ILAC SAN VE TIC. A.S., TURKEY

ATC 코드:

Selective calcium channel blockers with mainly vas

INN (국제 이름):

Metoprolol

복용량:

100 mg

약제 형태:

Film Coated Tablet

Manufactured by:

ILKO ILAC SANAYI VE TICARET, TURKEY

제품 요약:

Physical description: Homogeneous, white colored, round, biconvex, scored on one side film coated tablet; Local technical representative: GENERICS & SPECIALITIES LIMITED (9801)

승인 상태:

Registered/Compliant

승인 날짜:

2021-08-20

제품 특성 요약

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR PULSATYL SDK (METOPROLOL SUCCINATE
95MG EQUIVALENT TO METOPROLOL TARTRATE 100 MG) CONTROLLED RELEASE
FILM COATED TABLETS
VERSION NUMBER 0.1
3
RD
JANUARY, 2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD, P. O. BOX
1253, DODOMA – TANZANIA, TELEPHONE: [phone]/+255
(22)
2450512/2450751/2452108, EMAIL: [e-mail], Website:
WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1
1.
INTRODUCTION
PULSATYL
SDK
is
a
generic
medicine
of
Lopressor.
PULSATYL
SDK
is
an
antihypertensive
medicine belonging to
C07AB02-
Beta-receptor blocker, selective
group. Metoprolol is a beta-1 selective beta blocker. It has a
relatively greater blocking
effect on beta receptors (i.e. those mediating adrenergic stimulation
of heart rate and
contractility and release of the fatty acids from fat stores) than on
beta receptors which
are chiefly involved in broncho and vasodilation. Metoprolol only
exhibits insignificant
membrane stabilising effect and has no agonist effect. Metoprolol
reduces or blocks the
stimulating effect of catecholamines (particularly released in case of
physical or mental
stress) on the heart. Metoprolol reduces tachycardia, decreases the
cardiac output and
the
contractility,
and
lowers
the
blood
pressure.
If
required,
metoprolol
may
be
administered
concomitantly
with
a
beta-2
agonist
to
patients
with
symptoms
of
obstructive pulmonary disease. PULSATYL SDK is approved in Tanzania
for use in
adults and elderly.
1.1
PRODUCT DETAILS
Registration number
TAN 21 HM 0326
Brand name
PULSATYL SDK
Generic name, strength and
form
Metoprolol succinate
ATC classification
C07AB02- Beta-receptor blocker, selective
Distribution category
POM
Country of origin
Turkey
Associated product
State any other product of formulation, strength or
site that is linked or associated with the product if
applicable
Marketi