Core73: The Summary of Product Characteristics

📄 High-yield / 要点：The Summary of Product Characteristics (SmPC/SPC) is the legally binding professional document that defines a medicine’s authorized indications, dosage, and key clinical/pharmacologic information.

Definition / 定義

• SmPC / SPC = professional specification for doctors and pharmacists included in the marketing authorization.
• Contains key information about:
  • The medicine.
  • Conditions of use.
  • Characteristics of the medicine.
• It is a legally binding document.
• Use outside the listed indication or dosage is considered off-label.

Main structure of the SmPC / SmPCの基本構成

Section	Content
1	Name of the medicinal product
2	Qualitative and quantitative composition
3	Pharmaceutical form
4	Clinical particulars
5	Pharmacological properties
6	Pharmaceutical particulars
7	Marketing authorization holder
8	Marketing authorization number(s)
9	Date of first authorization / renewal
10	Date of revision of the text

Section 5: Pharmacological properties / 第5章

• 5.1 Pharmacodynamic properties
  • ATC code.
  • Mechanism of action.
  • Clinical efficacy (often study data).
• 5.2 Pharmacokinetic properties
  • ADME and variation in special populations.
• 5.3 Preclinical safety data

Section 4: Clinical particulars / 第4章

4.1–4.5

• 4.1 Therapeutic indications
• 4.2 Posology and method of administration
  • Includes special populations and pediatric use.
• 4.3 Contraindications
  • Situations where the drug must not be used.
• 4.4 Special warnings and precautions for use
• 4.5 Interactions with other medicinal products and other forms of interaction

4.6–4.9

• 4.6 Fertility, pregnancy and lactation
• 4.7 Effects on ability to drive and use machines
• 4.8 Undesirable effects
  • Listed by organ system and frequency.
• 4.9 Overdose
  • Symptoms and treatment suggestions.

Why it matters / なぜ重要か

• The SmPC is the main legal and professional reference for:
  • Indications.
  • Dosing.
  • Contraindications.
  • Warnings.
  • Interactions.
  • Adverse effects.

Remember / 覚え方

• SmPC = official professional drug reference
• Section 4 = clinical use
• Section 5 = pharmacology
• 4.3 contraindications / 4.4 warnings / 4.8 adverse effects are especially high-yield