Therapeutic category of approved drugs during the study period
| Therapeutic categories | Number of drugs | Number of drugs with paediatric data | Number of drugs without paediatric data* | Examples of usage of drugs without paediatric data |
|---|---|---|---|---|
| Oncology | 41 | 2 | 11 | PH+ AML, melanoma, thyroid cancer |
| Infectious disease | 35 | 14 | 21 | HIV, multidrug-resistant TB |
| Endocrine/metabolic | 27 | 5 | 22 | DM, IEM, dyslipidemia |
| Neurology | 17 | 7 | 4 | MS, partial seizure |
| Psychiatry | 12 | 1 | 11 | MDD, schizophrenia, insomnia, smoking cessation |
| Gastrointestinal | 11 | 0 | 11 | IBS, SBS, HIV-associated Diarrhoea, chemo-associated nausea |
| Cardiology | 10 | 0 | 6 | HTN, PAH |
| Urology | 10 | 0 | 5 | Over active bladder |
| Diagnostic imaging | 9 | 2 | 4 | CNS or cardiac vascular imaging |
| Haematology | 7 | 1 | 4 | Iron overload, anaemia, thrombocytopenia |
| Dermatology | 6 | 2 | 4 | Actinic keratosis, dispersion of injected drugs |
| Ophthalmology | 6 | 3 | 3 | Macular degeneration, OAG, postoperative inflammation |
| Pulmonology | 6 | 2 | 4 | Obstructive pulmonary disease |
| Allergy/immunology | 4 | 3 | 1 | Hereditary angioedema |
| Anaesthesia/analgesia | 3 | 0 | 3 | Sedation, analgesia, refractory pain |
| Toxicology | 3 | 3 | 0 | – |
| Nephrology | 2 | 0 | 2 | Hypercalcemia, ESRD |
| Obstetrics/gynecology | 2 | 2 | 0 | – |
| Rheumatology | 2 | 0 | 1 | DMARD |
| Total | 213 | 47 | 118 |
*Drugs with paediatric indication but no paediatric data.
CNS, central nervous system; DM, diabetes mellitus; DMARD, disease modifying antirheumatic drug; ESRD, end-stage renal disease; HTN, hypertension; IBS, irritable bowel syndrome; IEM, inborn errors of metabolism; MDD, major depressive disorder; MS, multiple sclerosis; OAG, open-angle glaucoma; Drugs with paediatric indication; PAH, pulmonary arterial hypertension; PH+ AML, Philadelphia positive acute myeloid leukaemia; SBS, short bowel syndrome; TB, tuberculosis.