1. |
Name of the medicinal product |
2. |
Qualitative and quantitative composition |
3. |
Pharmaceutical form |
4. |
Clinical particulars |
4.1. |
Therapeutic indications |
4.2. |
Posology and method of administration |
4.3. |
Contraindications |
4.4. |
Special warnings and precautions for use |
4.5. |
Interaction with other medicinal products and other forms of interaction |
4.6. |
Pregnancy and lactation |
4.7. |
Effects on ability to drive and use machines |
4.8. |
Undesirable effects |
4.9. |
Overdose |
5. |
Pharmacological properties |
5.1. |
Pharmacodynamic properties |
5.2. |
Pharmacokinetic properties |
5.3. |
Preclinical safety data |
6. |
Pharmaceutical particulars |
6.1. |
List of excipients |
6.2 |
Incompatibilities |
6.3. |
Shelf life |
6.4. |
Special precautions for storage |
6.5. |
Nature and contents of container |
6.6. |
Special precautions for disposal and other handling |
7. |
Marketing authorization holder |
8. |
Marketing authorization numbers |
9. |
Date of first authorization/renewal of authorization |
10. |
Date of revision of the text |