Lofral 10mg Tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

AMLODIPINE BESILATE

Available from:

MEPHARM (MALAYSIA) SDN BHD

INN (International Name):

AMLODIPINE BESILATE

Units in package:

30Tablet Tablets

Manufactured by:

Atlantic Pharma S.A.

Summary of Product characteristics

BPFK
416.3
MINOR
VARIATION
NOTIFICATION
I;ORM
FOR
FULL
EVALUATION
PRODUCTS
.
_Please _
_rud _
_the _
_following _
_instructions _
_before _
_filling _
_in _
_the _
_form. _
1)
This
notification
form
is
for
Product
Registration
Holder
(PRH)
to
notify
National
Pharmaceutical
Control
Bureau
(NPCB)
on
the
implementation
of
MiV-Notification
(MiV-N)
as
per
Malaysian
Variation
Guideline
(MVG).
The
timeline
for
NPCB
to
acknowledge
the
variation
notification
is
within
20
working
days
following
receipt
of
a
notification.
2)
Please
refer
to
the
MVG
for
the
conditions
and
supporting
documents
required.
3)
Submission
of
relevant
revised
draft
of
package
insert
and
labeling
is
subject
to
current
regulatory
requirements
as
per
the
latest
Drug
Registration
Guidance
Document
(DRGD)
and
Circulars
from
NPCB.
In
the
event
that
the
revised
draft
of
package
insert
and
labeling
does
not
meet
the
current
regulatory
requirements,
please
submit
under
Minor
Variation
Prior
Approval
(MiV-PA)
or
Major
Variation
(MaV).
4)
PRH
must
submit
this
notification
form
together
with
the
online
submission
through
the
Quest
2
system
as
the
approval
will
only
be
notified
via
online
submission.
For
submission
online,
please
scan
this
form
and
attach
together
with
the
revised
draft
of
package
insert
and
labeling
as
a
single
file.
5)
A
MiV-N
application
may
be
rejected
in
specific
circumstances
with
the
consequence
that
the
PRH
must
cease
to
apply
the
already
implemented
variation.
S)
The
completed
form
must
be
submitted
to
:
Seksyen
Variasi,
Pusat
Pasca
Pendaftaran
Prod
uk,
Biro
Pengawalan
Farmaseutikal
Kebangsaan,
Kementerian
Kesihatan
Malaysia,
Lot
36,
Jalan
Universiti,
46200
Petaling
Jaya,
Selangor.
(Fax
No:
03-79567151)
Product
Name:
LOFRAL
10MG
TABLET
Name
and
address
of
product
registration
holder:
MEPHARM
(MALAYSIA)
SON.BHO.
15,
JALAN
USJ
1119,
TMN
SUBANG
PERMAI
47600
SUBANG
JA
YA,
SELANGOR
Reference
Number:
2006053027325
Tel.
No.:
03·56368088
Registration
Number:
MAL07031138AC
Fax
No.:
03·5636
8133
Date
of
online
submission
in
Quest
System:
_If/f