Tipranavir

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

EMA’s scientific discussion

EMA’s scientific discussion for Aptivus (tipranavir), 2005-04-11.

"An assessment of the risk was performed and no significant risk to the environment related to the use of tipranavir is anticipated." No data are presented.

Assessment report

Assessment report for Aptivus, variation assessment report, 23 April 2009, EMEA/CHMP/259943/2009.

The CHMP agreed with the MAH’s (Marketing Authorisation Holder) position that an ERA (Environmental Risk Assessment) was not required, as the use of tipranavir is not expected to increase when some adults switch from capsules to the oral solution, and only few children are anticipated to be treated. Consequently, no significant increase in environmental exposure to TPV tipranavir is expected.