Documents transmis le 16/03/2021 - Travoprost - ANSM

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AMM Vizitrav 40 microgrammes/ml, collyre en solution (2017) (21/05/2021)

Travoprost - Annexe 54 - Power of attorney (2014) (21/05/2021)

Travoprost - Annexe 54 - Power of attorney (2014) (21/05/2021)

Travoprost - Annexe 56 (2014) (21/05/2021)

Travoprost - Manufacturer's authorisation (2014) (21/05/2021)

Travoprost - Letter of access to DMF for Travoprost (2014) (21/05/2021)

Travoprost - Letter of access to DMF for Travoprost (2014) (21/05/2021)

Travoprost - List of Mock-ups or Samples/specimens sent with the application, as appropriate (2013) (21/05/2021)

Travoprost - List of proposed (invented) names and marketing authorisation holders in the concerned member states (2013) (21/05/2021)

Travoprost - Certificate of GMP complicance of a manufacturer (2014) (21/05/2021)

Travoprost - Certificate of GMP complicance of a manufacturer (2013) (21/05/2021)

Travoprost - Certificate of GMP complicance of a manufacturer (2013) (21/05/2021)

Travoprost - Submission of Application Dossier(s) for Marketing Authorisation of Travoprost (21/05/2021)

Travoprost - History of e-CTD sequences (2014) (21/05/2021)

Travoprost - Declaration (2014) (21/05/2021)

Travoprost - Package leaflet: Information for the user (2013) (21/05/2021)

Travoprost - Justification for Absence of Environmental Risk Assessment (2013) (21/05/2021)

Travoprost - Labelling (2013) (21/05/2021)

Travoprost - Information for abridged application (2013) (21/05/2021)

Travoprost - Notice to applicants (2013) (21/05/2021)

Travoprost - Risk management plan (2014) (21/05/2021)

Travoprost - Summary of the valeant pharmacovigilance system (2014) (21/05/2021)

Travoprost - Summary of product characteristics (2013) (21/05/2021)

Travoprost - Extrait KBis (2014) (21/05/2021)

Travoprost - Appendices (2013) (21/05/2021)

Travoprost - Clinical summary (2013) (21/05/2021)

Travoprost - Introduction (2013) (21/05/2021)

Travoprost - Nonclinical summary (2013) (21/05/2021)

Travoprost - Quality overall summary (2013) (21/05/2021)

Travoprost - Regional Information /For Eu (2013) (21/05/2021)

Travoprost - Non-clinical study reports (2013) (21/05/2021)

Travoprost - Clinical study reports (2013) (21/05/2021)

Travoprost - Power of attorney (2015) (21/05/2021)

Travoprost - Braille (2013) (21/05/2021)

Travoprost - Bridging report (2013) (21/05/2021)

Travoprost - Submission of Validation sequence of the Application Dossier(s) for Marketing Authorisation of Travoprost/ PharmaSwiss 40 micrograms/Ml preservative free eye drops, solution in multi dose container (2015) (21/05/2021)

Travoprost - History of e-CTD sequences (2015) (21/05/2021)