OXYTETRACYCLINE 250 MILLIGRAM TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-05-2024
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Active ingredient:
OXYTETRACYCLINE DIHYDRATE
Available from:
Clonmel Healthcare Ltd
Dosage:
250 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1988-03-28
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0126/032/001
Case No: 2045663
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
CLONMEL HEALTHCARE LIMITED
WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
OXYTETRACYCLINE 250 MILLIGRAM TABLETS
The particulars of which are set out in Part I and Part II of 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 28/03/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/07/2008_
_CRN 2045663_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxytetracycline 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Oxytetracycline equivalent to 250 mg Oxytetracycline Dihydrate.
Excipients: Lactose monohydrate 18.56mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated Tablet (tablet)
Yellow, biconvex, film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oxytetracycline is indicated in the treatment of infections due to sensitive micro-organisms such as: acute and chronic
bronchitis (including prophylaxis of acute exacerbations), broncho-pneumonia, atypical pneumonia caused by
mycoplasma pneumonia,
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