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Pharmaceuticals - Community Register
List of nationally authorised medicinal products for human use
|Active substance:||Prednisolone sodium phosphate|
|Indication:||Allergy and anaphylaxis: Severe allergic and anaphylactic reactions, bronchial|
• Arteritis/collagenosis: Giant cell arteritis, mixed connective tissue disease,
• Blood disorders: Haemolytic anaemia (autoimmune), leukaemia (acute and
lymphatic), malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic
• Cardiovascular disorders: Rheumatic fever with severe carditis.
Substitution therapy: Adrenal cortex insufficiency of any pathogenesis (e.g. M.
Addison, congenital adrenal hyperplasia, adrenalectomy, ACTH deficiency) after the
growing phase (first-choice therapies are hydrocortisone and cortisone)
• Gastrointestinal disorders: Crohn's disease, ulcerative colitis, autoimmune chronic
• Infectiology: Toxic conditions in the context of severe infectious diseases (in
connection with antibiotics/ chemotherapy), e.g. tuberculous meningitis, severe form
of progressive pulmonary tuberculosis.
• Neurology: Myasthenia gravis (first-choice therapy is azathioprine), chronic Guillain-
Barré syndrome, Tolosa-Hunt syndrome, polyneuropathy with monoclonal
gammopathy, subacute demyelating polyneuropathy, multiple sclerosis (for gradual
oral reduction after high-dose parenteral glucocorticoid administration), acute
exacerbations of multiple sclerosis, cerebral oedema as a result of cerebral metastases.
• Ocular diseases: In systemic diseases involving the eyes and in immunological
processes in the orbita and in the eye: optic neuropathy (e.g. giant cell arteritis,
anterior ischaemic optic neuropathy (AION), traumatic optic neuropathy), Behçet's
• Renal disorders: Selected cases of nephrotic syndrome
• Pneumology: Asthma (administration of bronchodilators at the same time is
recommended), acute COPD exacerbation (recommended duration of therapy is up to
10 days), interstitial lung diseases such as acute alveolitis, pulmonary fibrosis , longterm
therapy of chro
|Marketing Authorisation Holder:||Pharmapol Arzneimittelvertrieb-GmbH|
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|06/09/2013||Referral||EMEA/H/A-29/1368||(2013)5785 of 05/09/2013|