Regulatory PathRegulatory requirements compared

Active substance

Hydroxocobalamin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DEPOVIT B12 1000 AMP 1ML1.04 mgSolution for injection · Intramuscular use2 AmpouleSAR 7.85Generic · PrescriptionALAMRIAH FOR PHARMACEUTICALS INDUSTRIESValid
Depovit B121 mgSolution for injection · Intramuscular use5 AmpouleSAR 19.60Generic · PrescriptionAMRIYA FOR PHARMACEUTICAL INDUSTRIESValid
Indications — CHI Daman Drug Formulary

BARIATRIC SURGERY; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); VITAMIN B12 DEFICENCY ANEMIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
HYDROXOCOBALAMIN1MG/MLinjectable · injectionACTAVISPrescription16 Aug 1978
CYANOKIT5GM/VIAL (5GM/KIT)injectable · injectionBTG INTLPrescription15 Dec 2006
ALPHAREDISOL1MG/MLinjectable · injectionMERCKDiscontinued18 Apr 1975
HYDROXOMIN1MG/MLinjectable · injectionBEL MARDiscontinued1 May 1981
CYANOKIT2.5GM/VIAL (5GM/KIT)injectable · injectionBTG INTLDiscontinued15 Dec 2006
HYDROXOCOBALAMIN1MG/MLinjectable · injectionABRAXIS PHARMDiscontinued
HYDROXOCOBALAMIN1MG/MLinjectable · injectionWATSON LABSDiscontinued

EMA European Union — centrally authorised medicines

Cyanokit SERB SA · Authorised · authorised 23 Nov 2007 · ATC V03AB33

Therapeutic indication (EMA)

Treatment of known or suspected cyanide poisoning. Cyanokit is to be administered together with appropriate decontamination and supportive measures.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CYANOKIT023753705 G / VIALPOWDER FOR SOLUTION · INTRAVENOUSSERB S.A.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACHYDROXOCOBALAMIN 1,000 MCG/ML$0.8144per ML18 Mar 2026
NHS Drug TariffHydroxocobalamin 1mg/1ml solution for injection ampoules£9.715 ampoule1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 10.1. Antianaemia medicines · core
    Megaloblastic anaemia due to vitamin B12 deficiency
    Parenteral > General injections > IM: 1 mg per mL in 1 mL ampoule (as acetate); 1 mg per mL in 1 mL ampoule (as hydrochloride); 1 mg per mL in 1 mL ampoule (as sulfate)

Safety signals and safety-related labeling changes

  • US FDA 31 Dec 2018 CYANOKIT — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for hydroxocobalamin →

Combinations containing Hydroxocobalamin

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.