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Is Prescrire overly alarmist about conditional marketing authorisations?

 Outlook   Following the publication (in Prescrire International n° 246) of an Editors’ Opinion on the withdrawal of the conditional marketing authorisation for rucaparib (Rubraca°) in certain types of ovarian cancer, we received a letter from a senior official at the European Medicines Agency (EMA). This letter provides us with the opportunity to review the issues and risks associated with “conditional” marketing authorisations.
(see also "Winners and losers" Prescrire Int n° 246, subscribers only)
Full article available for download by subscribers

©Prescrire 1 April 2024

Source: "Is Prescrire overly alarmist about conditional marketing authorisations?" Prescrire Int 2024; 33 (258): 107-109. Subscribers only..

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See also:

"Rucaparib in relapsed
ovarian cancer: a recklessly
approved indication revoked"
Prescrire Int 2023;
32 (246): 73.
Subscribers only

"Negative post-marketing trials:
often ignored"
Prescrire Int 2023;
32 (254): 304-305.
Subscribers only

"Post-marketing studies
following conditional authorisation:
often lacking"
Prescrire Int 2023;
32 (254): 307.
Subscribers only


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