By: Karla Salmerón
The Monograph of a product must contain the following information:
(a) Internationally accepted common or generic name and strength of the drug.
b) Pharmaceutical form
c) Structure, chemical name of the active ingredient
d) Clinical Pharmacology
e) Indications
f) Contraindications
g) Precautions and warnings
h) Interactions
i) Adverse effects
j) Dosage and administration
k) Recommendations in case of overdosage according to the toxicological profile
l) Abuse and addiction
m) Date of revision of the monograph
n) Complete bibliography reference list
o) Therapeutic category according to the anatomical therapeutic classification (ATC), in the pharmacological subgroup updated version
p) Form of preparation
If you need any advice, please contact our team of professionals in the Life Sciences-Regulatory Affairs area through the communication channels indicated in our platforms.