Details PYRUKYND

Data as extracted from Orphan Designation Register

Product (OD)

PYRUKYND

PL number (OD)

PLGB 52779/0001

OD Designation ID (OD)

Active substance (OD)

Mitapivat sulfate Potent, allosteric activator of wild-type red blood cell (RBC)-specific form of pyruvate kinase (PKR) and a range of mutant PKR enzymes. Mitapivat targets the underlying enzymatic defect that causes haemolysis in pyruvate kinase deficiency by restoring the activity of mutant forms of PKR.

Data as extracted from SMPC. (PS: More information at bottom of the page)

Product (SMPC)

PL Number (SMPC)

Composition/ Active Substance (SMPC)

Dose form (SMPC)

Marketing Authorisation holder details (SMPC)

IDMP View

Structured regulatory data for this product mapped to the IDMP entity hierarchy (ISO 11615) — Marketing Authorisation, Medicinal Product, and Administrable Product.
Note: Wherever a type is listed as "Equivalent Term not known", we dont have the information available in public domain. However, this data is usually available in eAF (or equivalent) form and is stored by most regulators as strucutured data - albeit not always in same hierarchy as IDMP.

No IDMP data is linked to this authorisation number.

AI match to EMA Substance Dictionary

We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.

SMPC composition / active substance

Matched EMA substance

EMA SMS ID

Confidence

Higher confidence means the match is more likely to be correct.

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FDA Approved Products —

Products approved by the FDA containing the matched EMA substance, sourced from OpenFDA Drugs@FDA.

No EMA substance match available — FDA lookup skipped.

Further information for:

Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.

OD Indication (OD)

Pyrukynd is indicated for the treatment of pyruvate kinase deficiency (PK deficiency) in adult patients

Full Designation Number(OD)

PLGB 52779/0001-0005OD1

Orphan Condition(OD)

pyruvate kinase deficiency (PK deficiency)

All Indications (SMPC)

All Contraindications (SMPC)

Warnings/Precautions (SMPC)

Interactions (SMPC)

Pregnancy/Lactation (SMPC)

Driving/Machines (SMPC)

Undesirable effects (SMPC)

Overdose (SMPC)

Shelf life (SMPC)

Storage (SMPC)

Container description (SMPC)

Handling/Disposal (SMPC)

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