| Document Date: 2013-10-03 11:33:54
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Company Neurim Pharmaceuticals EEC Limited / / Currency pence / MOP / / / Facility Elimination Terminal / / IndustryTerm medicinal products / food / antidepressant medicinal products / / MedicalCondition rare hereditary problems / Polyuria / Gastro-oesophageal reflux / Abdominal pain / insomnia / Priapism / rebound insomnia / Hypertension / disease / headache / arthralgia / restless legs syndrome / nasopharyngitis / Leukopenia / Arthritis / Dermatitis / Eczema / muscle spasms / Vertigo / cirrhosis / Migraine / primary insomnia / disorientation / Glycosuria / erythema / lethargy / Syncope / LAPP lactase deficiency / Contraindications Hypersensitivity / vomiting / blister / Fatigue / drowsiness / Angina pectoris / Angioedema / disorder / psoriasis / Hypersensitivity / restlessness / dizziness / withdrawal symptoms / pruritus / neck pain / psychomotor hyperactivity / rash / back pain / autoimmune diseases / / MedicalTreatment hormone replacement therapy / / Organization Concomitant administration / US Federal Reserve / European Union / / Position General / / Product PHARMACEUTICAL FORM Prolonged-release tablet / Talc / carbamazepine / QUALITATIVE AND QUANTITATIVE COMPOSITION Each / cimetidine / zolpidem / zaleplon / / Technology pharmacokinetics / / URL http /
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS