Table 2 Topical (non-cutaneous) off-label medicinal products including EMDs in their composition.

From: Assessment of mandatory declaration excipients in pediatric off label prescriptions in Spain

Medicinal product

Route of Administration

Number of prescriptions (% of total) *

ATC code

EMD

EMD quantity on SmPC

Dexamethasone eye drops

Eye

315,665

(6.4%)

S03C - Corticosteroids and antiinfectives in combination

S03CA - Corticosteroids and anti-infectives in combination

S03CA01 - Dexamethasone and antiinfectives

Benzalkonium chloride

0.04 mg/mL

Budesonide 100 mcg nasal spray

Nasal

49,162

(1%)

R01A - Decongestants and other nasal preparations for topical use

R01AD - Corticosteroids

R01AD05 - Budesonide

Polysorbate 80 (E 433)

Not disclosed

  1. Notes: *Considering total off-label prescriptions analysed = 4,922,984. Calculation of % of total = [Number of prescriptions by medicinal product/Total number of off-label prescriptions] *100; Degree of harm of EMDs for pediatric individuals split into 3 categories, being “low” (white rows), “moderate” (light grey rows), and ”severe” (dark grey rows) | Abbreviations: ATC: Anatomical Therapeutic Chemical Classification System; EMD: Excipient of mandatory declaration; mcg: Microgram; mL: Millilitre; mg: Milligram; SmPC: Summary of Product Characteristics | Sources6,8,11,12:.
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