Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Dexamethasone Alapis

Product name: Dexamethasone Alapis
INN: dexamethasone
Indication: Dexamethasone is a corticosteroid. It is designed for use in certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema and for diagnostic testing of adrenocortical hyperfunction.
Endocrine disorders:
Endocrine exophthalmos.
Non-endocrine disorders:
Dexamethasone may be used in the treatment of non-endocrine corticosteroid responsive conditions including: Allergy and anaphylaxis: Anaphylaxis. Arteritis collagenosis: Polymyalgia rheumatica, polyarteritis nodosa.
Haematological disorders:
Haemolytic anaemia (also auto immune), leukaemia, myeloma, idiopathic thrombocytopenic purpura in adults,reticulolymphoproliferative disorders (see also under oncological disorders).
Gastroenterological disorders: For treatment during the critical stage in: ulcerative colitis (rectal only); regional enteritis (Crohn's disease), certain forms of hepatitis.
Muscular disorders:
Polymyositis.
Neurological disorders: Raised intra-cranial pressure secondary to cerebral tumours, acute exacerbations of multiple sclerosis.
Ocular disorders: Anterior and posterior uveitis, optic neuritis, chorioretinitis, iridocyclitis, temporal arteritis, orbital pseudotumour.
Renal disorders: Nephrotic syndrome.
Pulmonary disorders:
Chronic bronchial asthma, aspiration pneumonitis, chronic obstructive pulmonary disease (COPD), sarcoidosis, allergic pulmonary disease such as farmer's and pigeon breeder's lung, Löffler's syndrome, cryptogenic fibrosing alveolitis.
Rheumatic disorders:
some cases or specific forms (Felty's syndrome, Sjörgen's syndrome) of rheumatoid arthritis, including juvenile rheumatoid arthritis, acute rheumatism, lupus erythematosus disseminatus, temporal arteritis (polymyalgia rheumatica).
Skin disorders:
Pemphigus vulgaris, bullous pemphigoid, erythrodermas, serious forms of erythema multiforme (Stevens-Johnson syndrome), mycosis fungoides, bullous dermatitis herpetiformis.
Oncological Disorders:
lymphatic leukaemia, e
Marketing Authorisation Holder: Alapis S.A.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/10/2011 Referral EMEA/H/A-29/1308 (2011)7794 of 24/10/2011