Archived News

11 October 2013
5th “Meet the Expert in Paediatric Formulations Webinar” – now available for download!
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10 -13 October 2013
Foundation in Paediatric Pharmaceutical Care Third International Master Class
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23 January 2013

Entry into force of new regulations for pharmaceutical excipients
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01 October 2012
New EU flavourings list made possible with EFSA’s evaluations
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01 October 2012

New Term Will Distinguish Tablets Known To Split in Half
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29 March 2012

Bipartisan Bill to strengthen testing of pediatric drugs launched in USA

US Representative Mike Rogers (Republican, Michigan) this week introduced bipartisan legislation with Representatives Anna Eshoo (Democrat, California) and Ed Markey

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12 March 2012

Paediatric safety fears targeted in EMA excipient update

The EMA plans to update its excipient guidelines to cover safety concerns surrounding use in children and pregnant women.

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23 December 2011
Infant Acetaminophen Dosage Change May Cause Confusion
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30 September 2011
FLAVORx Study Presented at 3rd Annual European Paediatric Formulation Initiative (EuPFi) Conference
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11 July 2011

Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)

Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012).

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24 June 2011

European Medicines Agency gives first positive opinion for paediatric-use marketing authorisation

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given its first positive opinion for a paediatric-use marketing authorisation (PUMA) for Buccolam (midazolam), from ViroPharma SPRL, intended for the treatment of prolonged, acute, convulsive seizures in paediatric patients from the age of 3 months to 18 years.

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19 May 2011

[EU] EMA: Scientific guideline: Draft guideline on pharmaceutical development of medicines for paediatric use, draft: consultation open

[EU] EMA: Scientific guideline: Draft guideline on pharmaceutical development of medicines for paediatric use, draft: consultation open

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16 May 2011

Kids’ Liquid Acetaminophen Products to Be StandardizedDrugmakers to Standardize Pediatric Liquid Acetaminophen Product Concentration

Move to Drop Infant Formulation Aims to Minimize Dosing Errors

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05 May 2011

J&J Ending Run of Infant Acetaminophen Drops

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11 April 2011

Ban on phthalates, parabens and alkylphenols

Export and placing on the market for a consideration or free of cosmetic products for infants and children under three containing butylparaben and propylparaben are suspended until the adoption by the French Food Safety Agency health Products, a reasoned opinion to allow new operations

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08 March 2011

FDA have recently warned about the adverse consequences of propylene glycol as an excipient in oral meds for premature babies.

Propylene glycol is in the HIV combo drug Kaletra (lopinavir/ritonavir) oral solution.

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19 January 2011
Resolution CM/ResAP (2011) on quality and safety assurance requirements for medicinal products
prepared in pharmacies for the special needs of patients
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