CABERGOLINE 0.5 MILLIGRAM TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
CABERGOLINE
Available from:
Arrow Generics Limited
Dosage:
0.5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2008-02-08
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)
PA1130/014/001
Case No: 2062932
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ARROW GENERICS LIMITED
UNIT 2, EASTMAN WAY, STEVENAGE, HERTFORDSHIRE, SG1 4SZ, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CABERGOLINE 0.5 MG 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 16/03/2010 until 07/02/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/03/2010_
_CRN 2062932_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabergoline 0.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5mg cabergoline.
Excipient: lactose monohydrate 75mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A white to off-white, capsule-shaped tablet, embossed with ‘C | 5’ on one side and ‘partial score >’ on the other side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Inhibition of lactation for medical reasons.
Hyperprolactimaemic disorders.
Prolactin secreting pituitary adenomas.
Idiopathic hyperprolactinaemia.
It is recom
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