Ireland - English - HPRA (Health Products Regulatory Authority)

sintetica ireland limited - esketamine - solution for injection/infusion - 25 milligram(s)/millilitre - esketamine

Ireland - English - HPRA (Health Products Regulatory Authority)

sintetica ireland limited - esketamine - solution for injection/infusion - 5 milligram(s)/millilitre - esketamine

Ireland - English - HPRA (Health Products Regulatory Authority)

sintetica gmbh - esketamine hydrochloride - solution for injection/infusion - esketamine

Ireland - English - HPRA (Health Products Regulatory Authority)

sintetica gmbh - esketamine hydrochloride - solution for injection/infusion - esketamine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

as kalceks a.s. - esketamine hydrochloride 5,77 mg/ml - eq. esketamine 5 mg/ml - solution for injection/infusion - 5 mg/ml - esketamine hydrochloride 5.77 mg/ml - esketamine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

as kalceks a.s. - esketamine hydrochloride 28,85 mg/ml - eq. esketamine 25 mg/ml - solution for injection/infusion - 25 mg/ml - esketamine hydrochloride 28.85 mg/ml - esketamine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

as kalceks a.s. - esketamine hydrochloride 28,85 mg/ml - eq. esketamine 25 mg/ml - solution for injection/infusion - 25 mg/ml - esketamine hydrochloride 28.85 mg/ml - esketamine

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - esketamine hydrochloride, quantity: 32.3 mg (equivalent: esketamine, qty 28 mg) - spray, nasal - excipient ingredients: disodium edetate; citric acid monohydrate; water for injections; sodium hydroxide - spravato is indicated for treatment resistant depression (major depressive disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current moderate to severe depressive episode).,spravato is to be initiated in conjunction with a newly initiated oral antidepressant.

Israel - English - Ministry of Health

j-c health care ltd - esketamine as hydrochloride - solution for spray - esketamine as hydrochloride 28 mg/vial - esketamine - spravato, in combination with a ssri or snri, is indicated for adults with treatment-resistant major depressive disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.spravato, co-administered with oral antidepressant therapy, is indicated in adults with a moderate to severe episode of major depressive disorder, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.limitations of use: the effectiveness of spravato in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. use of spravato does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of spravato.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sintetica ltd - esketamine hydrochloride - solution for injection - 25mg/1ml