YorkaPig-HF-RBM20 Swine

Manufacturer
Recombinetics, Inc.
Effective date
2026-05-20
Label type
INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:52:58

Label at a glance#

ProductYorkaPig-HF-RBM20 Swine
Active ingredientSUS SCROFA G.(NC_010456.5)121244982C>A + 121244988-121244989CG>TC + 121244991-121244992AG>TC ALTE...
Label structure7 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Identity: Transcription activator-like effector nuclease (TALEN) edit and homology dependent repair in Yorkshire breed porcine fetal fibroblasts to introduce a C>A base substitution at base pair 121,244,982 that generates a BglII restriction enzyme site used to genotype progeny from gene edited founders, a CG>TC base substitution at base pairs 121,244,988-121,244,989 that creates a coding sequence change from arginine to serine at amino acid 638 of the swine RBM20 protein, and a synonymous AG>TC base substitution at base pairs 121,244,991-121,244,992.

HEALTH CLAIM SECTION

Claim: Loss of RBM20 gene function as a result of this gene edit in the Yorkshire breed of swine produces symptoms consistent with the criteria for diagnosis of familial dilated cardiomyopathy disease in humans.

CONTRAINDICATIONS SECTION

Limitations: This is a model of progressive disease. Some of the disease symptoms associated with familial dilated cardiomyopathy disease in humans take time to develop, and like the human disease, are variable in presentation from animal to animal.

INDICATIONS & USAGE SECTION

Product Use: Model animals and/or materials derived from these animals are intended for purchase only under license agreement with Recombinetics, Inc., and solely for use in connection with the specific licensed biomedical research.

INDICATIONS & USAGE SECTION

Conditions of Use: This model animal and any products derived from it are for biomedical research purposes only and not for use in humans. This is an investigational animal. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.

WARNINGS AND PRECAUTIONS SECTION

WARNINGS & PRECAUTIONS:
Caution. This intentionally genetically altered animal and any products derived from it are for biomedical
research purposes only and are not for use in humans or as human or animal food.
YorkaPig-HF-RBM20 animals are not for resale. No reproduction, distribution, transportation, or other third
party transfer is allowed by the purchaser unless specifically agreed to in writing by Recombinetics, Inc.
YorkaPig-HF-RBM20 animals, or any materials derived from the YorkaPig-HF-RBM20 animals, are not intended
to enter the human or animal food supply.
YorkaPig-HF-RBM20 animals shall be euthanized in accordance with all applicable regulatory or industry
standards, and all animal remains must be disposed of by incineration. Purchaser must maintain detailed
records accounting for the location of all YorkaPig-HF-RBM20 animals, and all materials derived from the
YorkaPig-HF-RBM20 animals, from the time the animals are delivered to Purchaser through disposition by
incineration. Final disposition notification must be made to Recombinetics, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86086-003-01YorkaPig-HF-RBM20 Swine1 [arb'U] in 1 NOT APPLICABLENOT APPLICABLE14

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86086-00386086-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.