Table 2. Changes in different sections of the summary of product characteristics of antibiotics as a result of referral procedures, European Union, 2007–2020.
| Summary of product characteristics section | Referrals | |
|---|---|---|
| 4.1 Therapeutic indications | 15 | |
| Addition/revision | 2 | |
| Deletion | 13 | |
| Deletion of: group of indication, a disease specific indication, treatment use and prophylactic use | 5 | |
| Deletion of a disease specific indication, group of indication and treatment use | 5 | |
| Deletion of a disease specific indication, treatment use and prophylactic use | 1 | |
| Deletion of a disease specific indication and treatment use | 1 | |
| Deletion of group of indication and treatment use | 1 | |
| 4.2 Posology and method of administration | 15 | |
| Modification in posology | 3 | |
| Adjustment of dosage for specific population | Paediatric patients | 5 |
| Paediatric patients and patients with reduced renal function | 1 | |
| Paediatric patients and patients with reduced renal and hepatic function | 1 | |
| Changes in the method of administration | 1 | |
| Changes in the method of administration and adjustment of dosage for patients with reduced renal function | 1 | |
| Changes in the method of administration and adjustment of dosage for paediatric patients | 1 | |
| Changes in the method of administration, adjustment of dosage for paediatric patients and patients with reduced renal function | 2 | |
| 4.3. Contraindications | 15 | |
| Harmonisation | 11 | |
| Hypersensitivity | 9 | |
| Use during pregnancy and in patients with G6PDa | 1 | |
| Hypersensitivity and children under 12 years | 1 | |
| Deletion | 2 | |
| Unchanged | 2 | |
| 4.4. Warnings | 15 | |
| Amendment/harmonisation | 15 | |
a Patients with glucose-6-phosphate dehydrogenase deficiency.