Latest medicines approvals announced in Scotland and Wales

Latest medicines approvals announced in Scotland and Wales

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  • Latest medicines approvals announced in Scotland and Wales

    Latest medicines approvals announced in Scotland and Wales

    Wednesday, 22 June 2016 14:31
  • Which? challenges dietary supplements claims around reducing dementia risk

    Which? challenges dietary supplements claims around reducing dementia risk

    Tuesday, 21 June 2016 13:23
  • High dose loperamide linked with serious heart problems

    High dose loperamide linked with serious heart problems

    Tuesday, 21 June 2016 11:45
  • CAM users less likely to start chemotherapy for breast cancer

    CAM users less likely to start chemotherapy for breast cancer

    Wednesday, 18 May 2016 14:50
  • VMS may need to include iron and folic acid to help reduce some birth risks

    VMS may need to include iron and folic acid to help reduce some birth risks

    Wednesday, 11 May 2016 13:46

Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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MHRA1March 21 2016

A consultation on changing the legal category of Ibuprofen Seven Plus 200mg/5ml Oral Suspension from prescription only medicine (POM) to pharmacy only (P) is underway.

Ibuprofen 100mg/5ml suspension is available without prescription, but the Commission on Human Medicines has now advised that a 200mg/5ml strength can be made available as a P medicine.

Setting out its proposals, the medicines regulator, the MHRA, has flagged up a potential risk of confusion over the different strengths as no other OTC ibuprofen 200mg/5ml preparations are available at the moment. “The risk is that a parent/carer, who may be used to giving quantities of suspension suitable for the 100mg/5ml product, might give twice the dose to a child if they give the same amount of this product,” says the consultation document ARM 91.

To address this concern, “the company has proposed appropriate risk minimisation measures to manage the risk of confusion. This will be done by clear warnings on the leaflet and label, and by adding the words, ‘double strength’ clearly highlighted to the outer box and to the label on the bottle itself.

“Additionally, as a P medicine, this product will be supplied only from pharmacies under the supervision of a pharmacist and therefore pharmacy staff can provide additional advice on correct use.”

Ibuprofen Seven Plus 200mg/5ml Oral Suspension is made by Pinewwood Laboratories, and is licensed for rheumatic or muscular pain, headache, dental pain, feverishness, symptoms of cold and influenza in children aged 7-12 years.

The consultation runs until April 4.

Links:

MHRA announcement

MHRA ARM 91 consultation document

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