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MIMS Ireland: Irish Medicines Board

All entries for Irish Medicines Board

Ceftriaxone - Contraindication and risk

01 March 2010

Ceftriaxone - Contraindication in newborns and risk of calcium-ceftriaxone precipitation when administered/mixed with solutions containing calcium Ceftriaxone is a broad-spectrum cephalosporin antibiotic that is used to treat infections known or likely to be due to one or more susceptible micro-organisms... Read more

Avoiding Medication Errors with Perindopril Arginine/ Amlodipine (Acerycal) Combination Products

01 February 2010

The Irish Medicines Board has recently authorised the following combination products containing perindopril arginine and amlodipine (Acerycal) for the Irish market.... Read more

Bisphosphonates and Osteonecrosis of the Jaw

04 January 2010

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

Update on H1N1 Pandemic Vaccines

01 December 2009

Update on National and EU Experience with the H1N1 Pandemic Vaccines The Irish Medicines Board (IMB), together with the European Medicines Agency and National Competent Authorities across the EU, is continuously monitoring the safety profile of H1N1v pandemic influenza vaccines.... Read more

IMB Update on Pandemic A(H1N1)v vaccines (2)

01 November 2009

The European Commission on the recommendation of the European Medicines Agency (EMEA) has granted licences for three vaccines against influenza A(H1N1)v for use in the EU. These vaccines are: Celvapan (Baxter), Focetria (Novartis), Pandemrix (GlaxoSmithKline).... Read more

Use of Antiviral Medicines for Pandemic Influenza

01 October 2009

IMB Update on Use of Antiviral Medicines for Pandemic (H1N1) 2009 Influenza (1). Antiviral medicines are available for the clinical management of pandemic (H1N1) 2009 influenza. Among the antiviral medicines that are authorised in the EU for use in an... Read more

Interaction between Clopidogrel and PPIs

01 August 2009

IMB Guidance on possible interaction between Clopidogrel and Proton Pump Inhibitors Clopidogrel is an antiplatelet drug authorised for the prevention of atherothrombotic events in patients suffering from myocardial infarction, ischaemic stroke or acute coronary syndrome, or those at risk of... Read more

Update on the safety of antipsychotic medicines

01 July 2009

Risk of stroke and increased risk of mortality in elderly patients treated for dementia.... Read more

Tibolone and Breast Cancer: Results of the LIBERATE trial

01 May 2009

Tibolone (Livial) is a synthetic hormone therapy that is licensed as a first-line treatment for menopausal symptoms and a second-line therapy for prevention of osteoporosis in postmenopausal women who are at high risk of future fracture.... Read more

Adverse reaction reporting

02 February 2009

The Irish Medicines Board monitors the safety of authorised medicinal products for human use available on the Irish market, on an on-going basis. Part of this monitoring is carried out through review and evaluation of suspected adverse reactions and the... Read more

Champix (varenicline)

05 January 2009

Champix (varenicline) is a medicinal product authorised for use throughout the European Union for the treatment of smoking cessation in adults. It is a non-nicotine aid which can help relieve the cravings and withdrawal symptoms associated with stopping smoking.... Read more

Acomplia (rimonabant)

IMB, Acomplia, rimonabant | 01 December 2008

The Irish Medicines Board (IMB) suspended the marketing and use of Acomplia in Ireland on 23rd October 2008 following a recommendation issued by the European Medicines Agency (EMEA) on the same date. This national action was taken following review of... Read more

HMG-CoA Reductase Inhibitors and muscular disorders

01 November 2008

(atorvastatin; fluvastatin ; pravastatin ; rosuvastatin; simvastatin) HMG-CoA reductase inhibitors, commonly known as ‘statins’ are a class of medicines authorised as an adjunct to diet for the treatment of hypercholesterolaemia, when the response to diet and other non-pharmacological treatments (e.g.... Read more

Antidepressants – Update on suicidal thoughts and behaviour

01 September 2008

Further to previous articles regarding the risk of suicidal behaviours associated with use of antidepressants, most recently in relation to children and adolescents (Drug Safety Newsletter -Issue 21, 2006), a comprehensive review of available clinical trial data for individual antidepressants... Read more

Champix (varenicline)

01 July 2008

Champix (varenicline) is a medicinal product authorised for use throughout the European Union through the European licensing process for the treatment of smoking cessation in adults. It is a non-nicotine aid which can help relieve the cravings and withdrawal symptoms... Read more

BCG Vaccine SSI – Update

01 April 2008

Further to previous articles on BCG Vaccine SSI1, including the outcome of a retrospective review of suspected adverse reactions associated with its use, this month’s article provides an update on experience of adverse reactions reported during 2007, in the context... Read more

Isotretinoin - Pregnancy Prevention Programme

01 March 2008

Isotretinoin is a medicinal substance approved for oral use in the treatment of severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Isotretinoin should only be prescribed by or under the supervision... Read more

Bisphosphonates and Osteonecrosis of the Jaw

01 February 2008

Further Class Review by the Pharmacovigilance Working Party (PhVWP) Bisphosphonates are a class of medicinal substances approved for various indications related to their inhibitory effect on bone resorption in certain malignant and benign diseases, including osteoporosis. For detailed information on... Read more

Moxifloxacin (Avelox) & Hepatic Failure and Serious Skin Reactions

01 January 2008

Important Safety Information Moxifloxacin (Avelox) & Hepatic Failure and Serious Skin Reactions Moxifloxacin (Avelox) is an antibacterial medicine authorised in Ireland for the treatment of the following bacterial infections: Acute exacerbation of chronic bronchitis Community acquired pneumonia, except severe cases... Read more