BETNELAN Tablets 500mcg Microgram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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:
BETAMETHASONE
Available from:
UCB Pharma Limited
Dosage:
500mcg Microgram
Pharmaceutical form:
Tablets
Authorization date:
1993-10-27
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)
PA0365/066/001
Case No: 2062927
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
UCB PHARMA LIMITED
208 BATH ROAD, SLOUGH, BERKSHIRE SL1 3WE, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BETNELAN 500 MICROGRAM 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 22/07/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/09/2009_
_CRN 2062927_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnelan 500 microgram Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms (0.5 mg) betamethasone.
Excipients: contains 97mg lactose per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Small, white flat tablet engraved ‘Betnelan Evans’ on one side and scored on the reverse.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone is a glucocorticosteroid which is about eight to ten times as active as prednisolone on a weight-for-
Read the complete document
