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7. Post-authorisation Safety Studies (PASS)
7.1. Protocols of PASS imposed in the marketing authorisation(s) 31
7.1.1. Ethinylestradiol, gestodene transdermal patch (NAP)
Evaluation of an imposed PASS protocol
Regulatory details:
PRAC Rapporteur:
Administrative details:
Procedure scope: PASS protocol of EURAS-CORA
MAH(s): Bayer (Apleek)
Background
A protocol for a study entitled European Active Surveillance Study COmparing Regimens of Application
(EURAS-CORA) was submitted for assessment by the PRAC by the MAHs for a transdermal patch
containing ethinylestradiol and gestodene in accordance to the EC decision Annex IV conditions to the
marketing authorisation of the concluded Art.31 referral procedure for combined hormonal
contraceptives.
Conclusion
The PRAC appointed Isabelle Robine (FR) as Rapporteur for the assessment of the protocol and
adopted a timetable for review of the protocol for PRAC decision in July 2014.
7.1.2. Sodium, magnesium, potassium sulphates for bowel preparation (NAP)
Evaluation of an imposed PASS protocol
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
Administrative details:
Procedure scope: Protocol for a multi-centre European observational drug utilisation study (DUS) of
post-commitment BLI800 to assess drug utilisation in the real life setting in a representative sample of
the European target population
MAH(s): Ipsen Pharma (Eziclen, Izinova)
Background
A protocol for a multicentre European observational drug utilisation study (DUS) to assess utilisation of
sodium, magnesium, potassium sulphates for bowel preparation in the real life setting in a
representative sample of the European target population was submitted by the MAH of the nationally
authorised products Eziclen and Izinova as part of the of their post-authorisation commitments.
Conclusion
The PRAC appointed Isabelle Robine (FR) as Rapporteur for the assessment of the protocol and
adopted a timetable for review of the protocol for PRAC decision in July 2014.
31 In accordance with Article 107n of Directive 2001/83/EC
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 38/75