LANZIOP 15 Milligram Capsules Gastro-Resistant

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

LANSOPRAZOLE

제공처:

Norton Waterford

INN (국제 이름):

LANSOPRAZOLE

복용량:

15 Milligram

약제 형태:

Capsules Gastro-Resistant

처방전 유형:

Product subject to prescription which may be renewed (B)

승인 상태:

Withdrawn

승인 날짜:

0000-00-00

제품 특성 요약

IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0436/041/001
Case No: 2072581
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NORTON WATERFORD
T/A IVAX PHARMACEUTICALS IRELAND, UNIT 301, IDA INDUSTRIAL PARK, CORK ROAD, WATERFORD, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LANZIOP 15MG GASTRO-RESISTANT CAPSULES
the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in
the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 18/08/2010 until 10/11/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/08/2010_
_CRN 2072581_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lanziop 15mg Gastro-resistant Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15 mg of lansoprazole.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
White gelatin gastro-resistant capsule, filled with white to light brown or lightly pink coloured enteric-coated pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
o
Treatment of duodenal or gastric ulcers, verified by endoscopy or radiography.
o
Treatment of reflux oesophagitis.
o
Long-term prophylaxis of reflux oesophagitis.
o
Zollinger-Ellison syndrome.
4.2 POSOLOGY AND METHOD OF