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MIMS Ireland: January 2010

Bisphosphonates and Osteonecrosis of the Jaw

04 January 2010 | Irish Medicines Board

Risk Minimisation and Recommended Preventative Dental Measures Bisphosphonates are a class of medicines approved for various indications related to their inhibitory effect on bone resorption in certain diseases, including prophylaxis and treatment of osteoporosis; treatment of Paget’s disease; and as... Read more

Caltrate

04 January 2010 | New Products

Company: Wyeth Consumer Healthcare. Legal category: Pharmacy only. GMS. Sport permitted. Active ingredients: Calcium (as carbonate) 600mg, cholecalciferol 10µg (eq. to 400 I.U. vitamin D3). Description: Capsule-shaped grey/beige tablets. One side is scored and engraved with D on the left... Read more

Ciloxan Ear Drops

04 January 2010 | New Products

Company: Alcon Laboratories (UK) Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Ciprofloxacin (HCl) 3mg/ml. Description: Clear, colourless to pale yellow solution. Presentation: 5ml, €4.38. Indication: Acute otitis externa due to susceptible strains of bacterial species shown to be... Read more

Cipralam

04 January 2010 | New Products

Company: Actavis Ireland Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Citalopram (as hydrobromide) 10mg, 20mg. Description: White, circular, biconvex film-coated tablets. 20mg tablet scored on both sides and can be divided into equal halves. Presentation: 10mg-28, € 9.04;... Read more

Combineb

04 January 2010 | New Products

Company: Clonmel Healthcare Ltd. Legal category: Prescription. GMS. Sport restricted -agonists. Active ingredients: Ipratropium bromide (as monohydrate) / salbutamol (as sulphate), 0.5mg/2.5mg per 2.5ml. Description: Colourless nebuliser solution in ampoule. Presentation: 2.5ml-60, €26.40. Indication: Management of bronchospasm in patients suffering... Read more

Donelinn

04 January 2010 | New Products

Company: Helsinn Birex Therapeutics Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Donepezil (HCl) 5mg, 10mg. Description: 5mg: White, round, biconvex film-coated tablets, marked DZ 5 on one side.10mg: Pale yellow, round, biconvex film-coated tablets, marked DZ 10 on... Read more

Grepid

04 January 2010 | New Products

Company: Pinewood Healthcare. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Clopidogrel (as besilate) 75mg. Description: Pink, round, biconvex, film-coated tablets. Presentation: 28, €34.79. Indication: Prevention of atherothrombotic events in adult patients suffering from myocardial infarction (from a few days... Read more

Ipravent

04 January 2010 | New Products

Company: Clonmel Healthcare Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Ipratropium bromide 250µg/1ml. Description: Clear, colourless nebuliser solution. Presentation: 1ml-20, €4.08; 2ml-20, €4.85. Indications: Reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD). With concomitant inhaled β2-agonists, for... Read more

Kyflam

04 January 2010 | New Products

Company: Actavis Ireland Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Diclofenac (K+) 50mg. Description: Reddish brown, circular, biconvex film-coated tablets. Presentation: 56, €6.32. Indications: Short-term treatment of all grades of pain and inflammation in the following acute conditions:... Read more

Lochol

04 January 2010 | New Products

Company: Clonmel Healthcare Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Fluvastatin 20mg, 40mg. Description: 20mg: Size 3, hard capsules with blue cap and white body. 40mg: Size 1, hard capsules with green cap and white body. Presentation: 20mg-28,... Read more

OsvaRen

04 January 2010 | New Products

Company: Fresenius Medical Care Ireland Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredients: Calcium acetate, 435mg (eq. to 110mg calcium), magnesium carbonate, 235mg (eq. to 60mg magnesium). Description: White to yellowish, oblong film-coated tablet with a single score line.... Read more

Renvela

04 January 2010 | New Products

Company: Genzyme Therapeutics. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Sevelamer carbonate 800mg; 2.4g. Description: 800mg: White to off-white tablets. 2.4g: Pale yellow powder for oral suspension. Presentation: 800mg-180, €184.53; 2.4g-60, €184.53. Indications: Control of hyperphosphataemia: In adults receiving... Read more

Thymoglobuline

04 January 2010 | New Products

Company: Genzyme Therapeutics. Legal category: Prescription. Sport permitted. Active ingredient: Rabbit anti-human thymocyte immunoglobulin 25mg (5mg/ml in reconstituted solution). Description: Powder for solution for infusion in vial. Presentation: 25mg-1. Price available on request. Indications: Immunosuppression in solid organ transplantation, in... Read more

Tizaflex

04 January 2010 | New Products

Company: Actavis Ireland Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Tizanidine 2mg, 4mg. Description: White, round tablets. 2mg: Marked N62. 4mg: Scored and marked N63 on the other side. Presentation: 2mg-120, €66.69; 4mg-120, €83.37. Indication: Spasticity associated with... Read more

Valherp

04 January 2010 | New Products

Company: Ergha Healthcare Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Valaciclovir (HCl) 500mg. Description: Creamy, oblong film coated tablets. Presentation: 10, €18.50; 30, €55.49; 42, €77.66. Indications: Treatment of herpes zoster (shingles). Treatment and prevention (suppression) of herpes... Read more

Valotix

04 January 2010 | New Products

Company: Rowex Ltd. Legal category: Prescription. GMS. Sport permitted. Active ingredient: Valaciclovir (HCl) 500mg. Description: White to off-white capsule shaped film coated tablets with 500 debossed on one side and plain on the other side. Presentation: 10, €19.14. Indications: In... Read more

Coversyl Arginine Plus 10mg/2.5mg

04 January 2010 | New Presentations

Prescription. GMS. Sport Prohibited Servier Laboratories are delighted to inform you that Coversyl Arginine Plus 10mg/2.5mg is now available for prescription in Ireland. Coversyl Arginine Plus 10mg/2.5mg contains 10mg of perindopril arginine and 2.5mg of indapamide, extending the range and... Read more

New Formulation for Ecalta

04 January 2010 | New Presentations

Hospital. Sport permitted. Pfizer Healthcare Ireland are pleased to announce the launch of Ecalta WFI, a new formulation of Ecalta. This new formulation, which is to be reconstituted with Water For Injections (WFI) will replace the current formulation containing ethanol... Read more

Nebilet Plus

04 January 2010 | New Presentations

Prescription. GMS. Sport Prohibited. A. Menarini Pharmaceuticals wishes to announce the launch of a new product, Nebilet Plus, a combination of nebivolol and hydrochlorothiazide. Nebilet Plus is indicated for the treatment of essential hypertension in patients whose blood pressure is... Read more

World Anti-Doping Agency announces changes to Prohibited List

04 January 2010 | New this Month

The World Anti-Doping Agency (WADA) has issued a new Prohibited List of Substances and Methods which comes into effect on 1 January 2010. Changes to the Prohibited List are as a result of ongoing reviews by the WADA List and... Read more

New indication for Foznol in Chronic Kidney Disease patients not on dialysis

04 January 2010 | New this Month

Shire Pharmaceuticals Ireland Ltd. have announced that they have received local market approval for an extension to the existing indication for Foznol. This licence extension makes Foznol, the non-calcium, non-resin phosphate binder, available to control hyperphosphataemia in chronic kidney disease... Read more

Amendments to Serenace entry

04 January 2010 | New this Month

MIMS Ireland editorial team wishes to notify you of the update of the entry for Serenace (haloperidol) including all Serenace presentations. Serenace is available as capsules (0.5mg), tablets (1.5mg, 5mg, 10mg, 20mg), as an oral solution (2mg/ml) and a solution... Read more

Centyl 2.5mg and Centyl 5.0mg Discontinued February 2010

04 January 2010 | Discontinued Products

Centyl 2.5mg and Centyl 5.0mg Discontinued February 2010 LEO Pharma would like to inform you of their intention to discontinue Plain Centyl 2.5mg and Centyl 5mg from the Irish market in February 2010. This discontinuation is not due to any... Read more

Anti-doping: 2010 Guide for Prescribers

01 January 2010 | Medicines and Sport

Abbreviations  TUE Therapeutic Use Exemption  ISTUE International Standard for Therapeutic Use Exemptions The World Anti-Doping Code, published by the World Anti-Doping Agency (WADA), harmonises anti-doping regulations across all sports and in all countries. This Code includes a list... Read more