Is Albumin human registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 23 valid registrations of Albumin human, including ALBUTEIN 20% SOLN. FOR INJ (20 %, Intravenous infusion, SAR 146.40); Albumin SK (20 %, Solution for injection, SAR 164.45); Alburex (200 g/l, Solution, SAR 249.10); FLEXBUMIN 200GM/L SOLUTION FOR INFUSION (200 g/l, Solution for infusion, SAR 156.55); HUMAN ALBUMIN 20% (20 %, Solution, SAR 146.40).

Is Albumin human approved by the US FDA?

Drugs@FDA lists 1 application product line for Albumin human, including OPTISON (Prescription).

Are there safety signals or safety updates for Albumin human?

US FDA: 1 entry (latest 2025-05-09).

Active substance

Albumin human

SFDA 34
US FDA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALBUTEIN 20% SOLN. FOR INJ	20 %	Intravenous infusion · Intravenous use	1 Vial	SAR 146.40	Biological · Prescription	GRIFOLS BIOLOGICALS LLC	Valid
Albumin SK	20 %	Solution for injection · Intravenous use	1 Vial	SAR 164.45	Biological · Prescription	SK Plasma Co. Ltd	Valid
Albumin SK	20 %	Solution for injection · Intravenous use	1 Vial	SAR 314.60	Biological · Prescription	SK Plasma Co. Ltd	Valid
Alburex	200 g/l	Solution · Intravenous use	1 Vial	SAR 249.10	Biological · Prescription	CSL BEHRING	Valid
Alburex	200 g/l	Solution · Intravenous use	1 Vial	SAR 154.95	Biological · Prescription	CSL BEHRING	Valid
FLEXBUMIN 200GM/L SOLUTION FOR INFUSION	200 g/l	Solution for infusion · Intravenous use	1 Bag	SAR 156.55	Biological · Prescription	Takeda Manufacturing AG	Valid
FLEXBUMIN 200GM/L SOLUTION FOR INFUSION	200 g/l	Solution for infusion · Intravenous use	1 Bag	SAR 285.85	Biological · Prescription	Takeda Manufacturing AG	Valid
HUMAN ALBUMIN 20%	20 %	Solution · Intravenous use	1 Vial	SAR 146.40	Biological · Prescription	OCTAPHARMA	Valid
HUMAN ALBUMIN 20%	20 %	Solution · Intravenous use	1 Bottle	SAR 213.85	Biological · Prescription	OCTAPHARMA	Valid
HUMAN ALBUMIN 20% +INFUSION SET	20 %	Solution · Intravenous use	1 Vial	SAR 138.55	Biological · Prescription	BIOTEST	Valid
HUMAN ALBUMIN 20% +INFUSION SET	20 %	Solution · Intravenous use	1 Bottle	SAR 262.90	Biological · Prescription	BIOTEST	Valid
HUMAN ALBUMIN 20% SOLUTION FOR INFUSION	20 %	Solution · Intravenous use	1 Vial	SAR 164.45	Biological · Prescription	HUMAN BioPlazma LLC	Valid
HUMAN ALBUMIN 20% SOLUTION FOR INFUSION	20 %	Solution · Intravenous use	1 Vial	SAR 314.60	Biological · Prescription	HUMAN BioPlazma LLC	Valid
HUMAN ALBUMIN 200G-I TAKEDA	20 %	Solution · Intravenous use	1 Vial	SAR 141.00	Biological · Prescription	Takeda Manufacturing AG	Valid
HUMAN ALBUMIN 5%	5 %	Solution · Intravenous use	1 Bottle	SAR 187.05	Biological · Prescription	OCTAPHARMA	Valid
HUMAN ALBUMIN 5%	5 %	Solution · Intravenous use	1 Bottle	SAR 190.60	Biological · Prescription	BIOTEST	Valid
HUMAN ALBUMIN 50G-I TAKEDA 250ML	5 %	Solution · Intravenous use	1 Bottle	SAR 209.55	Biological · Prescription	Takeda Manufacturing AG	Valid
Human Albumin Grifols 20%	20 %	Solution for infusion · Intravenous use	1 Vial	SAR 213.85	Biological · Prescription	Instituto Grifols, S.A	Valid
Human Albumin Grifols 20%	20 %	Solution for infusion · Intravenous use	1 Vial	SAR 146.40	Biological · Prescription	Instituto Grifols, S.A	Valid
PLASBUMIN 20%	20 %	Suspension for injection · Intravenous use	1 Vial	SAR 146.40	Biological · Prescription	GRIFOLS THERAPEUTICS INC	Valid
PLASBUMIN 20%	20 %	Suspension for injection · Intravenous use	1 Vial	SAR 213.85	Biological · Prescription	GRIFOLS THERAPEUTICS INC	Valid
UMAN ALBUMIN 20% SOLUTION FOR INFUSION	20 %	Solution · Intravenous use	1 Vial	SAR 122.75	Biological · Prescription	KEDRION	Valid
UMAN ALBUMIN 20% SOLUTION FOR INFUSION	20 %	Solution · Intravenous use	1 Bottle	SAR 245.50	Biological · Prescription	KEDRION	Valid
ALBUMINATIVE 20% I.V.	20 %	Solution · Intravenous use	1 Vial	SAR 215.25	Biological · Prescription	OCTAPHARMA	Withdrawn by MAH · Not Marketed
ALBUMINATIVE 20% I.V.	20 %	Solution · Intravenous use	1 Bottle	SAR 300.70	Biological · Prescription	OCTAPHARMA	Withdrawn by MAH · Not Marketed

9 more — full table

Indications — CHI Daman Drug Formulary

BURN MANAGEMENT; LIVER CIRRHOSIS; Septic Shock

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
OPTISON	10MG/ML	injectable · injection	GE HEALTHCARE	Prescription	31 Dec 1997

Safety signals and safety-related labeling changes

US FDA 9 May 2025 OPTISON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations

All safety entries for albumin human →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.