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Roche discontinue midazolam 10mg/5mL injection

31st July 2012

Roche have discontinued Midazolam hydrochloride (Hypnovel) 2mg/mL (5mL ampoule) solution for injection in the UK for commercial reasons. A generic midazolam 2mg/mL (5mL ampoule) injection formulation is available. The high strength Hypnovel formulation midazolam 5mg/mL (2mL ampoule) injection is still available.

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CQC annual report: safer management of controlled drugs

27th July 2012

The UK Care Quality Commission (CQC) has published their 2011 annual report on the safer management of controlled drugs. This fifth report makes a number of recommendations for accountable officers. Other key recommendations include:

• accountable officers must ensure the safe and effective use of transdermal fentanyl patches through establishing a suitable system and educating staff involved in prescribing, dispensing, administering and disposing of them

• methylphenidate and dexamfetamine should be monitored carefully to ensure that they are prescribed appropriately in all sectors.

• the use of a standard Controlled Drug Requisition Form (FP10 CDF) should be encouraged more actively.

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Cyclizine (Valoid) 50mg tablets license transferred to generic

18th July 2012

The UK marketing authorization (license) for cyclizine 50mg tablets (Valoid, Amdipharm) has been transferred to its sister company Waymade Healthcare. The Valoid brand of tablets is no longer available in the UK, however generic cyclizine 50mg tablets (100 pack) are now available through Waymade’s Sovereign livery (01268 535230). The generic cyclizine 50mg tablets can be obtained via the usual wholesalers and there are no known supply issues.

It is thought that the marketing authorization for cyclizine 50mg tablets (Valoid) in Ireland, New Zealand and Australia is to remain with Amdipharm.

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MHRA launches new website section for medicines information

12th July 2012

A new section has been added to the UK Medicines and Healthcare products Regulatory Agency (MHRA) website, bringing together the different types of information related to medicines. The following sources of information are linked to from this page (see below):

  • Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)
  • Drug Analysis Prints
  • Drug Safety Updates
  • Public Assessment Reports
  • Summaries of risk management plans
  • Yellow card site.

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Olanzapine injection to be discontinued in UK

10th July 2012

Olanzapine injection, powder for reconstitution 5mg/mL, 10mg vial (Zyprexa; Lilly) is to be withdrawn in the UK on 31/8/12, for sales volume reasons and not for any safety reason. There is no generic or alternative rapid-acting olanzapine injectable formulation available in the UK. It will still be available in other Countries outside the UK.

Note: the depot injection, olanzapine embonate (ZypAdhera; Lilly) will still remain available in the UK.

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FDA approve REMS for m/r opioids

10th July 2012

US Food and Drug administration (FDA) has approved a Risk Evaluation and Mitigation Strategy (REMS) program for all modified-release (m/r) opioids. Key components include prescriber training, updated patient information guides and counselling documents and manufacturer assessment/auditing requirements.

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FDA approve pregabalin for neuropathic pain associated with spinal cord injury

9th July 2012

US Food and Drug Administration (FDA) have approved pregabalin capsules and oral solution (Lyrica capsules or oral solution CV, Pfizer) for the treatment of neuropathic pain associated with spinal cord injury.

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Die Mai/Juni Ausgabe des APM Newsletter ist fertig.

3rd July 2012

The May/June issue of APM Newsletter for German-speaking users of is available.

Die Mai/Juni Ausgabe des APM Newsletter ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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