NOTICE TO APPLICANTSMedicinal Products for Human Use

The Programme and Evaluation Unit (led by a P-3, with two additional P-3s, three P-2s and one G-4) is responsible for ER 6: analysis of nominations, proposals and

For example, in 2003 the authors held an invi- tational workshop to develop a “shared national vision regarding CAM in UME.” Yet it appears that the list of participants

Knowledge about low dose radiation induced health risks is particularly important in the field of diagnostic imaging using IR, in which typically doses much lower than 100 mGy

For DE/H/6160/001/DC, the proposed product name “TERIPARATIDE BIOGARAN 20 microgrammes / 80 microlitres, solution injectable en stylo prérempli” is acceptable in France.

In order to optimise national notifications, both French and English electronic versions of the final approved SPC, package leaflet and labelling in Word format / Template 10 should

1) The product name TERIWEL is not acceptable in France as it is too close to TORISEL from PFIZER EUROPE MA EEIG. 1 Please note that for 10.1 and 10.3 applications with a

Annex 5.19 – List of proposed (invented) names and marketing authorisation holders in the concerned member states for. Travoprost-Timolol Horus Pharma (40micrograms/mL+5mg/mL)

Concerned Member State (specify) Belgium Concerned Member State (specify) Bulgaria Concerned Member State (specify) Czech Republic Concerned Member State (specify) Germany