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National Drug Formulary

VYNDAMAX SOFT GELATIN CAPSULE 61MG [SIN15894P]

Active ingredients: VYNDAMAX SOFT GELATIN CAPSULE 61MG

View product's general information
Last updated 24 April 2026

Product Info

VYNDAMAX SOFT GELATIN CAPSULE 61MG

[SIN15894P]

Product information

Active Ingredient and Strength

TAFAMIDIS - 61 MG

Dosage Form

CAPSULE

Manufacturer and Country

CATALENT PHARMA SOLUTIONS - UNITED STATES
ANDERSONBRECON INC. (PRIMARY PACKAGER) - UNITED STATES

Registration Number

SIN15894P

Licence Holder

PFIZER PRIVATE LIMITED

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

N07XX08

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1 Therapeutic indications

VYNDAMAX is indicated for the treatment of transthyretin amyloidosis in adult patients with wild-type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation.

Dosing

4.2 Posology and method of administration

Posology

The recommended dose of VYNDAMAX is 61 mg tafamidis orally once daily (see Section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

VYNDAMAX can be taken with or without food.

Special populations

Paediatric
VYNDAMAX should not be prescribed in the paediatric population as transthyretin amyloidosis is not a disease present in this population.

Elderly
No dosage adjustment is required for elderly patients (≥65 years) (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal or hepatic impairment
No dosage adjustment is required for patients with renal impairment, or mild or moderate hepatic impairment. VYNDAMAX has not been studied in patients with severe hepatic impairment.

Method of administration

Oral use.

The capsule(s) should be swallowed whole and not crushed or cut. VYNDAMAX may be taken with or without food.

If a dose is missed, the patient should take the dose as soon as remembered. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients of VYNDAMAX (see Section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).