Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
(2S)-3-Methyl-2-[N-({2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1-biphenyl]-4-yl}methyl)pentanamido]butanoic acid
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
(2S)-3-Methyl-2-[N-({2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1-biphenyl]-4-yl}methyl)pentanamido]butanoic acid
PBT status:
the substance is not PBT / vPvB
Justification:

The substance is not P/vP:

Chronic aquatic toxicity: not classified

The substance is not B/vB:

The substance has low logKow value (1.2) and is not of greater concern because it has low potential to bio-concentrate in living organisms.

The substance is not T:

Post-Marketing Experience in Human

In addition to the safety experience gained from clinical trials, analysis of adverse event reports received from the market since the first introduction in 1996 has revealed very rare cases of angioedema, rash, pruritus, and other hypersensitivity/allergic reactions including serum sickness and vasculitis. Very rare cases of impaired renal function have also been reported. In addition, myalgia was observed as a rare adverse event with valsartan in a Prescription-Event-Monitoring study of around 13,000 patients in England [CRD-49]. Another study of monitoring adverse events in England reported that dyspnea was one of the most commonly reported events in association with valsartan. Based on post-marketing reports, several European countries have included the occurrence of very rare cases of bleeding and thrombocytopenia in association with valsartan into the local product information. Based on post-marketing reports, hyponatremia was added to the local product information in the EU.

Exposure in number of patient treatment years was calculated on the basis of sales data assuming an average daily dose of one tablet per day per patient. Total exposure to valsartan until 30 Apr 2014 is approximately 95 million patient treatment years for adults and 28,654 patient treatment years for pediatric use based on the amount of valsartan tablets sold.

Categories Display