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Molecule

Elosulfase alfa

Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
Available on requestBiologicOrphanCold chainRare diseases and enzyme replacement
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Elosulfase alfa is a hydrolytic lysosomal glycosaminoglycan-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA, Morquio A syndrome). It is available as injection for intravenous use. MedsAcross supplies Elosulfase alfa for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
ATC classification
A16AB12 Elosulfase alfa · Metabolic disease treatments, including enzyme replacement, subgroup A16A, subgroup A16AB
US FDA first approval
14 February 2014
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII ODJ69JZG85RxCUI 1489914CAS 9025-60-9DrugBank DB09051Q21011232

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

VIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA, Morquio A syndrome). VIMIZIM is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA, Morquio A syndrome).

Source: US FDA prescribing information

How it works

Mucopolysaccharidoses comprise a group of lysosomal storage disorders caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAG). Mucopolysaccharidosis IVA (MPS IVA, Morquio A Syndrome) is characterized by the absence or marked reduction in N -acetylgalactosamine-6-sulfatase activity. The sulfatase activity deficiency results in the accumulation of the GAG substrates, KS and C6S, in the lysosomal compartment of cells throughout the body. The accumulation leads to widespread cellular, tissue, and organ dysfunction. VIMIZIM is intended to provide the exogenous enzyme N-acetylgalactosamine-6-sulfatase that will be taken up into the lysosomes and increase the catabolism of the GAGs KS and C6S.

Source: US FDA prescribing information

Dosing overview

Administration of VIMIZIM should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. 2 mg per kg body weight administered once every week as an intravenous infusion over a minimum of 3.5 to 4.5 hours, based on infusion volume. See the full prescribing information for administration modifications due to hypersensitivity reactions.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (hypersensitivity reactions including anaphylaxis and risk of acute respiratory complications): Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Risk of Acute Respiratory Complications: Patients with acute febrile or respiratory illness may be at higher risk of life-threatening complications from hypersensitivity reactions. Careful consideration should be given to the patient's clinical status prior to administration of VIMIZIM and consider delaying the VIMIZIM infusion.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis. Risk of Acute Respiratory Complications. Spinal or Cervical Cord Compression. Most common adverse reactions (≥10%) are: pyrexia, vomiting, headache, nausea, abdominal pain, chills, and fatigue.

Source: US FDA prescribing information

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Elosulfase alfa, sorted by availability.

MedicineManufacturerRegisterAvailability
Vimizim 5 mg/5 mL injectionIntravenous Cold chainBioMarin PharmaceuticalUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 14 February 2014Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Elosulfase alfa available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Elosulfase alfa and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Elosulfase alfa have?

The catalogue lists 1 brand names for Elosulfase alfa, including Vimizim.

Is Elosulfase alfa approved by the US FDA?

Yes. The US FDA first approved Elosulfase alfa on 14 February 2014, according to Drugs@FDA.

Is Elosulfase alfa authorised in the European Union?

Yes. Elosulfase alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Elosulfase alfa need cold chain shipping?

At least one listed presentation of Elosulfase alfa must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Elosulfase alfa in?

Elosulfase alfa is classified under ATC code A16AB12 (Elosulfase alfa).

References

  1. VIMIZIM prescribing information (BioMarin Pharmaceutical). U.S. National Library of Medicine, DailyMed. Retrieved 30 October 2025
  2. Vimizim: European public assessment report (EPAR). European Medicines Agency. Retrieved 23 October 2025

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