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Medicines
Spain
Vitamin b12

AEMPS 1972

Vitamin b12

Isopto B12 0,5 MG/ML Colirio en Solucion

0,5 mg colirio en soluciónSpainMarketedAuthorised 31 Oct 1972

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

AmicoredBrazil · Vasconcelos Industria Farmaceutica e Comercio LtdaSame substance
BedozilBrazil · Laboratil Farmaceutica LtdaSame substance
BedozilBrazil · Valeant Farmacêutica do Brasil LtdaSame substance
Cyanocobalamin Injection USPCanada · 1000 MCG / ML · Solution · Hikma Canada LimitedSame substance
Cyanocobalamin Injection USPCanada · 1000 MCG / ML · Solution · Sterimax INCSame substance
Cyanocobalamin Injection USPCanada · 1000 MCG / ML · Solution · Hikma Canada LimitedSame substance
AnkermannItaly · Compressa rivestita · Aaa - Pharma GMBHSame substance

More with the same substance on this register

Becaren 1.000 Microgramos ComprimidosVitamin b12 · 1.000 µg · comprimidoSpain
Optovite B12 1.000 Microgramos Solución InyectableVitamin b12 · 1000 µg · solución inyectableSpain

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

🇮🇹DobetinItaly · Soluzione iniettabile · Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.P.A.Same substance

🇮🇹TonocianItaly · Soluzione iniettabile · So.Se.Pharm S.R.L. Societa' di Servizio per L'Industria Farmaceutica Ed AffiniSame substance

🇳🇱Cyanocobalamine CF 1 mg/ml, injectievloeistofNetherlands · Oplossing voor injectie · Centrafarm B.V.Same substance

🇷🇴VITAMINA B 12 ZENTIVA 1000µg/mlRomania · 1000µg/ml · sol. inj. · Zentiva SASame substance

🇷🇴VITAMINA B12 ZENTIVA 50 µg/mlRomania · 50µg/ml · sol. inj. · Zentiva S.A.Same substance

🇸🇦Betolvex Inj 1MGSaudi Arabia · Xellia Pharmaceutical ApsSame substance

🇸🇦CYNOVIT 1MG-1ML I.M. Injection*Saudi Arabia · Gulf Pharmaceutical Industries (Julphar)Same substance

🇸🇦CytobionSaudi Arabia · Merck Healthcare KGaASame substance

🇸🇬VITAMIN B12 INJECTION 1000 mcg/mlSingapore · 1000 mcg/ml · injection · Atlantic Pharmaceutical (S) Pte LTDSame substance

🇹🇼Co-B12 Forte TabletsTaiwan · 錠劑 · 熹樂企業有限公司Same substance

🇹🇼Cyanocobalamine Injection "Cyc"Taiwan · 注射劑 · 嘉原企業股份有限公司Same substance

🇺🇸CyanocobalaminUnited States · 0.5MG/SPRAY · spray, metered · Padagis IsraelSame substance

🇺🇸CyanocobalaminUnited States · 0.03MG/ML, 0.1MG/ML, 1MG/ML · injectable · LuitpoldSame substance

🇺🇸VibisoneUnited States · 1MG/ML · injectable · Fresenius Kabi USASame substance

Packs

Pack	Code	Status
ISOPTO B12 0,5 MG/ML COLIRIO EN SOLUCION , 1 frasco de 5 ml	735472

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Vitamin b12
Strength: 0,5 mg
Dosage form: colirio en solución
Route: vía oftálmica
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 31 Oct 1972
Registration: 50758
Marketing authorisation holder: Reva Health Europe S.L.
Procedure: National, MRP or DCP
Supply: Sin Receta

AEMPSVitamina B12 Farmasierra 1000 Microgramos Capsulas DurasVitamin b12 · 1 mg · cápsula dura🇪🇸Spain

AEMPSVitamina B12 Ankermann 1.000 Microgramos Comprimidos RecubiertosVitamin b12 · 1 mg · comprimido recubierto🇪🇸Spain

AEMPSCromatonbic B12 1000 InyectableVitamin b12 · 1 mg · solución inyectable🇪🇸SpainWithdrawn