CABASER 4MG TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
CABERGOLINE
Available from:
Pharmacia Laboratories Limited
Dosage:
4 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1999-10-29
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0187/061/003
Case No: 2036103
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PHARMACIA LABORATORIES LIMITED
RAMSGATE ROAD, SANDWICH, KENT, CT13 9NJ, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CABASER 4MG 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 10/05/2007 until 28/10/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/07/2007_
_CRN 2036103_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabaser 4 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg cabergoline as the active substance.
Each tablet also contains 301.6 mg of anhydrous lactose.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, oval, both sides concave tablets, one side scored and engraved “7” on the left of the breakline and “03” on the
right of it.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF PARKINSON'S DISEASE
If treatment with a dopamine agonist is being considered. Cabaser is indicated as second line therapy in patients who
are intolerant or fail treatment with
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