Serc 8mg Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Betahistine dihydrochloride

제공처:

Primecrown 2010 Limited

ATC 코드:

N07CA; N07CA01

INN (국제 이름):

Betahistine dihydrochloride

복용량:

8 milligram(s)

약제 형태:

Tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Antivertigo preparations; betahistine

승인 상태:

Authorised

승인 날짜:

2013-02-08

제품 특성 요약

Health Products Regulatory Authority
31 January 2019
CRN008LTD
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serc 8mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg betahistine dihydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from UK_
A white to almost white, round, flat tablet, imprinted '256' on one
face.
4 CLINICAL PARTICULARS
As per PA2010/016/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/016/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Mannitol (E421)
Citric acid monohydrate
Colloidal anhydrous silica
Talc
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
Health Products Regulatory Authority
31 January 2019
CRN008LTD
Page 2 of 2
The shelf –life expiry date of this product shall be the date shown
on the container
and outer package of the product on the market in the country of
origin
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
120 tablets in blister strips. The blister strips are made of PVC/PVDC
film with a
covering aluminium foil.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
Northolt
Middlesex UB5 5QS
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1633/026/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8
th
February 2013
10 DATE OF REVISION OF THE TEXT
January 2019