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PJ Online homeThe Pharmaceutical Journal
Vol 279 No 7479 p583
24 November 2007

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

    SPC changes Supply issues Suspension of marketing authorisation

Recalls
• Betaxolol hydrochloride
• Sodium cromoglicate


SPC changes

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

Aranesp SureClick
Information about dosing for chronic renal failure in adults and children has been updated in the summary of product characteristics for Aranesp SureClick (darbepoetin alfa; Amgen).

Efexor XL
Treatment of moderate to severe generalised social anxiety disorder/social phobia in adults has been added to the list of indications in the summary of product characteristics for Efexor XL (venlafaxine; Wyeth). The dose for this indication is 75mg once daily.

Pneumovax II
The use of Pneumovax II (pnuemoccocal polysaccharide vaccine) to treat children below two years of age is not recommended, the product’s summary of product characteristics now states. The safety and efficacy of the vaccine has not been studied in such patients and their antibody responses may be poor.

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Supply issues

Goldshield products
Lederfen tablets 300mg, liothyronine sodium tablets 20µg and stelazine tablets 1mg are available again from Goldshield after being out of stock. Medical information on 020 8588 9131. Customer services on 020 8588 9273.

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Suspension of marketing authorisation

Prexige
The Medicines and Healthcare products Regulatory Agency has suspended Novartis’s marketing authorisation for Prexige (lumiracoxib) tablets 100mg due to safety concerns about possible liver damage for patients.

Prescribers are asked not to issue any further prescriptions for Prexige and pharmacists not to dispense any further prescriptions for the drug. Novartis has stopped supplying Prexige to wholesalers and is recalling the product at the wholesale level.

Pharmacists (and other purchasers) should return any remaining stock to their wholesaler.

Medical information is available from Novartis on 01276 698370.

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