- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Valsartan (Diovan and associated names) is an angiotensin II receptor blocker (ARB), approved in adults for the treatment of hypertension. It has been marketed in Europe in adults as film coated tablets in doses of 80-160 mg since 1996 and in the highest dose of 320 mg since 2006.
Valsartan has been approved and marketed for the treatment of hypertension in children 6-17 years of age in the United States since 2007. Valsartan has also been approved for the treatment of heart failure and treatment of recent myocardial infarction in adults in many countries worldwide.
The present application was submitted under Article 29 of Regulation (EC) No 1901/2006 as amended, to extend the indication of the currently approved film coated tablets to include treatment of hypertension in paediatric patients aged 6 to 17 years and to update the product information to include data on the use of valsartan in the paediatric population. A parallel application has been submitted under Article 29 of Regulation (EC) No 1901/2006 as amended, to obtain approval for a new formulation (oral solution) intended to be used as a suitable alternative for paediatric patients.
Information on paediatric requirements
Pursuant to Article 8 of Regulation (EC) No 1901/2006 as amended, the application included an EMEA Decision (P/125/2009) for the following conditions:
- the agreement of a Paediatric Investigation Plan (PIP) for hypertension
- the granting of a waiver for heart failure and heart failure following recent myocardial infarction
The PIP is completed. The PDCO issued an Opinion on compliance.
Valsartan exerts its antihypertensive effect mainly by blocking the vasoconstriction, aldosterone secretion and sodium retention mediated by angiotensin II via selectively blocking the binding of angiotensin II to the AT1 receptor in tissues such as vascular smooth muscle and the adrenal gland. Valsartan has been shown to be effective in reducing both systolic and diastolic blood pressure in adults when used as monotherapy or in combination with other antihypertensive agents and is relatively well-tolerated.
Hypertension in children is defined as a persistent systolic blood pressure (SBP) or diastolic blood pressure (DBP) ≥ 95th percentile for age, gender, and height. Obesity, insulin resistance, inactivity, ethnic predisposition to essential hypertension, and family history of hypertension are the common causes of hypertension in older children and adolescents. However, in children younger than 10 years of age, secondary causes of hypertension, including renal and reno-vascular disease, are more commonly observed. Current epidemiologic data indicate that the prevalence of persistent hypertension in school-age children or above is approximately 1-2 percent, and in younger age children ( 6 years old) is extremely low (0.017%). Most children found to be hypertensive in the 6 year old age group present with severe, symptomatic hypertension due to underlying diseases (secondary hypertension). These patients often require pharmacological therapy to control blood pressure controlled. There is a paucity of data regarding the efficacy and pharmacokinetics of antihypertensive drugs in children. Antihypertensive medications have been extensively studied in adults, and most of them have been used commonly in hypertensive children, though few of them had been studied systematically in children until recently.
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
European Commission final decision
Article 29 paediatrics
This type of procedure may be triggered by a marketing-authorisation holder when applying for a new indication, new pharmaceutical form or new route of administration for use in children for a product authorised under Directive 2001/83/EC.
Key dates and outcomes
|CHMP opinion date||
|EC decision date||
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.