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List of medicines under additional monitoring

List of medicines under additional monitoring

List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Breyanzi, lisocabtagen...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Da...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Kavigale, sipavibart, ...

New Approach Methodologies EU-IN Horizon Scanning Report

New Approach Methodologies EU-IN Horizon Scanning Report

Annex to 24-27 February 2025 CHMP Agenda

Annex to 24-27 February 2025 CHMP Agenda

Agenda of the CHMP meeting 24-27 February 2025

Agenda of the CHMP meeting 24-27 February 2025

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Revinty Ellipta, fluti...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Relvar Ellipta, flutic...

Good manufacturing practice

Good manufacturing practice

Good distribution practice

Good distribution practice

Review of transparency rules for the EU Clinical Trials...

Review of transparency rules for the EU Clinical Trials Information System (CTIS)

Clinical Trials Information System

Clinical Trials Information System

European Medicines Agency procedural advice for users o...

European Medicines Agency procedural advice for users of the centralised procedu...

European Medicines Agency procedural advice for users o...

European Medicines Agency procedural advice for users of the centralised procedu...

European Medicines Agency pre-authorisation procedural ...

European Medicines Agency pre-authorisation procedural advice for users of the c...

European Medicines Agency pre-authorisation procedural ...

European Medicines Agency pre-authorisation procedural advice for users of the c...

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib, ...

Marketing authorisation application (MAA) - pre-submiss...

Marketing authorisation application (MAA) - pre-submission interactions form

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,v...

Pre-authorisation guidance

Pre-authorisation guidance

Human medicines European public assessment report (EPAR...

Human medicines European public assessment report (EPAR): Entresto, sacubitril,v...

Orphan designation: Adeno-associated virus serotype 9 c...

Orphan designation: Adeno-associated virus serotype 9 containing the human RPE65...

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