ATECOR Film Coated Tablet 100 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ATENOLOL
Available from:
Imbat Limited
Dosage:
100 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2008-03-07
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA1151/055/003
Case No: 2083791
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
IMBAT LIMITED
UNIT L2, NORTH RING BUSINESS PARK, SANTRY, DUBLIN 9
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ATECOR 100MG FILM-COATED TABLETS
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 31/08/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/08/2010_
_CRN 2083791_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atecor 100mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg Atenolol.
Excipients: lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Germany:_
White, round, biconvex, film-coated tablet with a score line on one face and marked '100' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a beta-adrenoceptor blocker ATECOR is indicated for the treatment of essential hypertension, angina pectoris and
cardiac dysrhythmias. This can be increased to 100 mg daily if required for control but should only be done after the
effects of
Read the complete document
