PDCO monthly report of opinions on paediatric investigation plans and other activities

The Paediatric Committee (PDCO) adopted opinions agreeing paediatric investigation plans (PIPs)
for the following medicines:

 • Lacosamide, EMEA-000402-PIP03-17, from UCB Pharma S.A., for the treatment of generalised epilepsy and epileptic syndromes;

• Omadacycline, EMEA-000560-PIP02-15, from Paratek UK Limited, for the treatment of acute bacterial skin and skin structure infections (ABSSSI);

 • Omadacycline, EMEA-000560-PIP03-15, Paratek UK Limited, for the treatment of bacterial pneumonia;

• Fluocinolone acetonide, EMEA-000801-PIP03-16, CAMPHARM Limited, for the treatment of chronic non-infectious uveitis;

 • Empagliflozin, EMEA-000828-PIP04-16, Boehringer Ingelheim International GmbH, for the treatment of type 1 diabetes mellitus;

 • Live, attenuated, chimeric dengue virus, serotype 1 / live, attenuated dengue virus, serotype 2 / live, attenuated, chimeric dengue virus, serotype 3 / live attenuated, chimeric dengue virus, serotype 4, EMEA-001888-PIP01-15, for the prevention of dengue fever;

• Larotrectinib, EMEA-001971-PIP02-16, Loxo Oncology, Inc., for the treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms);

 • Mexiletine (hydrochloride), EMEA-002012-PIP01-16, from Lupin (Europe) Ltd., for the treatment of myotonic disorders.