PEGCETACOPLAN - Food and Drug Administration

Set ID: da70f326-eccc-4ddc-93bb-212c53d94fc7
Type: Indexing - product concept
Effective date: 2023-10-02
Version: 1
Source: DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
Label	Relation	Manufacturer	Effective
These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021	Product name	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, LLC \| Eurofins Advantar Laboratories, LLC \| Bora Pharmaceuticals Injectables Inc. \| Nelson Laboratories, LLC \| AndersonBrecon Inc \| Cenexi HSC	2026-08-21
These highlights do not include all the information needed to use SYFOVRE safely and effectively. See full prescribing information for SYFOVRE. SYFOVRE ® (pegcetacoplan injection), for intravitreal use Initial U.S. Approval: 2021	Product name	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, Inc. \| Eurofins Advantar Laboratories, Inc. \| Micro Measurement Laboratories, Inc. \| West Services and Solutions LLC \| Packaging Coordinators, LLC \| Lifecore Biomedical LLC \| Lifecore Biomedical	2025-09-16
These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021	Product name	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, LLC \| Eurofins Advantar Laboratories, LLC \| Bora Pharmaceuticals Injectables Inc. \| Nelson Laboratories, LLC \| AndersonBrecon Inc \| Cenexi HSC	2025-07-30
Risk Evaluation and Mitigation Strategy (REMS) Document EMPAVELI (pegcetacoplan) REMS	Product name	Apellis Pharmaceuticals, Inc.	2025-07-28

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
73606-010	These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, LLC \| Eurofins Advantar Laboratories, LLC \| Bora Pharmaceuticals Injectables Inc. \| Nelson Laboratories, LLC \| AndersonBrecon Inc \| Cenexi HSC
73606-010-01	These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 2021	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, LLC \| Eurofins Advantar Laboratories, LLC \| Bora Pharmaceuticals Injectables Inc. \| Nelson Laboratories, LLC \| AndersonBrecon Inc \| Cenexi HSC
73606-020	These highlights do not include all the information needed to use SYFOVRE safely and effectively. See full prescribing information for SYFOVRE. SYFOVRE ® (pegcetacoplan injection), for intravitreal use Initial U.S. Approval: 2021	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, Inc. \| Eurofins Advantar Laboratories, Inc. \| Micro Measurement Laboratories, Inc. \| West Services and Solutions LLC \| Packaging Coordinators, LLC \| Lifecore Biomedical LLC \| Lifecore Biomedical
73606-020-01	These highlights do not include all the information needed to use SYFOVRE safely and effectively. See full prescribing information for SYFOVRE. SYFOVRE ® (pegcetacoplan injection), for intravitreal use Initial U.S. Approval: 2021	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, Inc. \| Eurofins Advantar Laboratories, Inc. \| Micro Measurement Laboratories, Inc. \| West Services and Solutions LLC \| Packaging Coordinators, LLC \| Lifecore Biomedical LLC \| Lifecore Biomedical
73606-020-02	These highlights do not include all the information needed to use SYFOVRE safely and effectively. See full prescribing information for SYFOVRE. SYFOVRE ® (pegcetacoplan injection), for intravitreal use Initial U.S. Approval: 2021	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, Inc. \| Eurofins Advantar Laboratories, Inc. \| Micro Measurement Laboratories, Inc. \| West Services and Solutions LLC \| Packaging Coordinators, LLC \| Lifecore Biomedical LLC \| Lifecore Biomedical
73606-020-11	These highlights do not include all the information needed to use SYFOVRE safely and effectively. See full prescribing information for SYFOVRE. SYFOVRE ® (pegcetacoplan injection), for intravitreal use Initial U.S. Approval: 2021	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, Inc. \| Eurofins Advantar Laboratories, Inc. \| Micro Measurement Laboratories, Inc. \| West Services and Solutions LLC \| Packaging Coordinators, LLC \| Lifecore Biomedical LLC \| Lifecore Biomedical
73606-020-12	These highlights do not include all the information needed to use SYFOVRE safely and effectively. See full prescribing information for SYFOVRE. SYFOVRE ® (pegcetacoplan injection), for intravitreal use Initial U.S. Approval: 2021	Apellis Pharmaceuticals, Inc. \| Juzen Chemical Corporation \| Bachem AG \| Eurofins Lancaster Laboratories, Inc. \| Eurofins Advantar Laboratories, Inc. \| Micro Measurement Laboratories, Inc. \| West Services and Solutions LLC \| Packaging Coordinators, LLC \| Lifecore Biomedical LLC \| Lifecore Biomedical