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Rosuvastatin and higher incidence of diabetes mellitus and gluscose metabolism disorders in healthy individuals without hyperlipidaemia

  • Agreed wording in SPC and PL
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Isotretinoin and the risk of erythema multiforme

SSRIs and TCAs and the risk of bone fractures

SSRIs, venlafaxine and mirtazapine and the risk of Persistent Pulmonary Hypertension in Neonates (PPHN)

Fluoxetine and the risk of Congenital Malformations

  • Agreed wording in SPC and PL (Revision June 2010)
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Propylthiouracil and the risk of serious liver injury

  • Agreed wording in SPC and PL
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Valproic Acid and the risk of interaction with carbapenems

Cyproterone acetate and the risk of meningiomas

  • Agreed wording in SPC and PL
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Association of HMG-CoA Reductase Inhibitors with safety concerns: sleep disturbances; memory loss; micturition disorders; sexual disturbance; depression; interstitial pneumopathy

  • Agreed wording in SPC and PL
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Phenytoin-related SJS in association with HLA-B*1502 allele in individuals of Thai or Han Chinese origin

  • Agreed wording in SPC and PL
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Apomorphine containing products and risk of QT interval prolongation

  • Agreed wording in SPC and PL
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Short-acting beta agonists and risk of myocardial ischemia

  • Agreed wording in SPC and PL
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Conventional (Typical) Antipsychotics and increased mortality in elderly people with dementia

  • Agreed wording in SPC and PL
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Antipsychotics and risk of venous thromboembolism (VTE)

  • Agreed wording in SPC and PL
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Vigabatrin and MRI abnormalities and movement disorders

  • Agreed wording in SPC and PL
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Ceftriaxone and the risk of precipitation when given with calcium

  • Agreed wording in SPC and PL (September 2009)
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Alendronic acid and the risk of stress fractures of the proximal femoral shaft

  • Agreed wording in SPC and PL (April 2009)
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Additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors

  • Agreed wording in SPC and PL (March 2009)
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Hydrochlorothiazide and use during pregnancy

  • Agreed wording in SPC and PL (March 2009)
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Angiotensin Converting Enzyme (ACE) inhibitors and Angiotensin II Receptor Antagonists (AIIRAs): Use during pregnancy & lactation

  • Agreed wording in SPC and PL (December 2008)
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Bisphosphonates and Atrial fibrillation

  • PhVWP recommended wording for SPC and PL (October 2008)
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Ibuprofen and low dose aspirin interaction

  • Agreed wording for SPC and PL (September 2008)
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Antiepileptics and suicidal behaviour

  • Key statement on Antiepileptics medicines & the risk of suicidal thoughts and behaviour (July 2008)
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  • Agreed wording for SPC and PL (July 2008)
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  • Questions & Answers - Antiepileptics medicines: risks of suicidal thoughts and behaviour (July 2008)
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Carbamazepine related Stevens Johnson Syndrome and association with HLA-B*1502

  • Agreed wording for SPC and PL (July 2008)
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Antidepressants and suicidal thoughts and behaviour

  • PhVWP Recommendations for wording in SPC and PL (January 2008)
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  • PhVWP Report - Antidepressants (January 2008)
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