Anpheros Search · Treatment

Midazolam

Also known as: Buccolam · Nayzilam

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In short

In the European Union, midazolam is indicated for the treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults, and it must only be used by parents or carers where the patient has been diagnosed with epilepsy. For infants between 3 and 6 months of age, this treatment should be administered in a hospital setting where monitoring is possible and resuscitation equipment is available. In the United States, midazolam injection is indicated intramuscularly or intravenously for preoperative sedation, anxiolysis, and amnesia, as well as intravenously for sedation, anxiolysis, and amnesia prior to or during diagnostic, therapeutic, or endoscopic procedures. It is also indicated in the United States intravenously for the induction of general anesthesia, as a component of intravenous supplementation of nitrous oxide and oxygen, and as a continuous intravenous infusion for the sedation of intubated and mechanically ventilated patients in a critical care setting. The cited source connects midazolam with epilepsy.

From: Source: European Medicines Agency (EMA), Buccolam — EPAR, 13/11/2024. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
6960 midazolam
EMA
EMEA/H/C/002267

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Buccolam

Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults.BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy.For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.2.

Source: European Medicines Agency (EMA), Buccolam — EPAR, 13/11/2024. © European Medicines Agency.

Document date: 13/11/2024 · Official document →

FDA (USA) Midazolam

INDICATIONS AND USAGE Midazolam Injection is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260619 · Official document →

Related terms in the cited sources

Has an official indication for

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External resources

Questions

What is Midazolam approved for in the European Union?

Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults.BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy.For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.2. (Source: European Medicines Agency (EMA), Buccolam — EPAR, 13/11/2024. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Buccolam — EPAR, 13/11/2024. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →