ELUDRIL Mouth Wash 0.1 %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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:
CHLORHEXIDINE GLUCONATE
Available from:
Pierre Fabre Medicament
Dosage:
0.1 %w/v
Pharmaceutical form:
Mouth Wash
Authorization date:
1999-06-25
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0329/001/001
Case No: 2053168
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE, 92100 BOULOGNE, CEDEX, FRANCE
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ELUDRIL MOUTHWASH 1 MG/ML
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 21/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/07/2010_
_CRN 2053168_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eludril Mouthwash 1 mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains chlorhexidine digluconate solution 0.005 ml (corresponding to 1 mg chlorhexidine
digluconate).
The content of chlorhexidine digluconate per ml when diluted as recommended is 0.22mg/ml - 0.33mg/ml
Excipients: contains Cochineal Red A (E124) 0.003g/100 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Mouthwash
Clear, pink liquid with an odour of menthol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the topical prophylaxis and management of inflammation and minor infections of the
mouth and oral pharynx, including use after
Read the complete document
