Table 1 PIPs/waivers approved by PDCO on September 2009.
From: The european paediatric legislation: benefits and perspectives
Therapeutic area | PIPs | Waivers |
|---|---|---|
Anaesthesiology | Â | 1(1RW) |
Bone disease | Â | 1 |
Cardiology | 1 | 5 |
Cardiology/endocrinology/metabolism | Â | 1 |
Cardiovascular diseases | 18 | 16 |
Dermatology | 6 | 2 |
Diagnostic and other | 1 | 1 |
Endocrinology | 1 | Â |
Endocrinology and metabolism | 6 | 5 |
Endocrinology/gynaecology/ | 3 | 3 |
Endocrinology/gynaecology/fertility/metabolism | 18 | 16 |
Gastroenterology | 1 | Â |
Gastroenterology Haemostaseology | 6 | Â |
Gastroenterology Hepatology | 6 (1RP) | 2 |
Gastroenterology-Hepatology Dermatology Immunology-Rheumatology-Transplantation | 1 | Â |
Gastroenterology-Hepatology/Immunology | 1 | Â |
Gynaecology | Â | 1 |
Haemathology | Â | 3 |
Haemathology/haemostaseology | Â | 1 |
Hepatology | 1 | Â |
Immunology | 3 | 1 |
Immunology/rheumatology/transplantation | 10 | 1 |
Infectious diseases | 24 | 1 |
Metabolism | 5 | Â |
Nephrology | Â | 1 |
Neonatology - paediatric intensive care | 1 | Â |
Neurology | 9 | 5 |
Nutrition | 2 | Â |
Oncology | 16 | 13 |
Oncology - Endocrinology-Gynaecology-Fertility-Metabolism - Immunology-Rheumatology-Transplantation | 1 | Â |
Ophthalmology | 3 | 6 |
Oto-rhino-laryngology | 1 | Â |
Oto-rhino-laryngology - Pneumology - Allergology - Dermatology | 1 | Â |
Pain | 9 | 7 |
Pain and neurology | 1 | Â |
Pneumology | 7 | 4 |
Pneumology - allergology | 5 | 3 (2RW) |
Psychiatry | 3 | 1 |
Rheumatology | Â | 2 |
Urology | Â | 2 |
Uro-Nephrology | 2 | 2 |
Vaccine | 20 | 2 |