| Document Date: 2014-05-06 09:51:21
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Company Accedo Arzneimittel GmbH / Germany DOC Generici S.r.l. / Rowex Ltd. / Apotex Europe B.V. / Davur S.L. Labochem Ltd. / Valeant Pharma Hungary LLC / Medicamentos Genéricos Lda. / Mylan Orifarm Generics A/S / Docpharma NV / Eurogenerics NV / Alfra / Laboratorios Basi Industria Farmaceutica SA / Basics Bexal Farmaceutica S.A. / Pentafarma Sociedade Tecnico-Medicinal SA / Genericon Pharma / ICN Polfa Rzeszow SA / Anselmo & Co / M.R. Pharma GmbH / Polpharma SA / Pharmakern Portugal Produtos Farmacêuticos Sociedade Unipessoal Lda. / Laboratórios Anova Produtos Farmacêuticos Lda / E. Tiefenbacher Alter S.A. / Farmoz Sociedade Tecnico-Medicinal SA / HCS BVBA Hexal Pharma GmbH / Ingers Industrial Solution S.r.o. / Alster Pharma Service GmbH APS / Johnson (Janssen-Cilag) 1A Pharma GmbH / Mer Medicamentos Lda. / Ford / Tecnimede Espana Industria Farmaceutica SA / Jacobsen Pharma A/S / Generics UK Generis Farmacêutica S.A. / Terapia Teva Pharmaceuticals Europe / RPG Sandoz SIA PLIVA Stada Arzneimittel TAD Pharma GmbH / Ciclum Farma CT Arzneimittel GmbH / Produtos Farmacêuticos SA / Medis Medochemie Ltd / PLIVA Premier Research GmbH / Produtos Farmacêuticos Lda. / Pharmachemie BV / Valeant Czech Pharma s.r.o. / / Country United Kingdom / / Event Product Issues / Product Recall / / IndustryTerm treatment of conduct disorder / mg oral solution / medicinal products / pharmaceuticals / / MedicalCondition polyuria / conduct disorder / dementia / clinically significant neutropenia / urinary retention / seizures / Reye’s syndrome / Leukopenia / Seizures RISPERDAL / idiopathic intracranial hypertension / severe Alzheimer’s dementia / cerebrovascular disease / diabetic coma / hypersomnia / hypothermia rhabdomyolysis / endocrine pancreatic tumours toxic skin disorders / numbness / bradycardia / Neuroleptic malignant syndrome / myoglobinuria / Clinically significant hypotension / muscle rigidity / brain tumour / intra-operative floppy iris syndrome / agranulocytosis / human breast tumours / hypotension / precocious puberty / intestinal obstruction / prolactin-dependent tumours / Tardive dyskinesia/extrapyramidal symptoms / Alzheimer’s dementia / cancer / schizophrenia / disease / Priapism Priapism / rhythmical involuntary movements / Intraoperative floppy iris syndrome / neutropenia / stroke / cardiovascular disease / dementias / diabetes / Rhabdomyolysis Rhabdomyolysis / ileus / Agranulocytosis QT / fever / Rhabdomyolysis / paralytic ileus / seizure / leukopenia/neutropenia / Contraindications Hypersensitivity / bipolar disorders / myocardial infarction / diabetes mellitus / heart failure / Parkinson’s disease / serious hepatobiliary disorders / floppy iris syndrome / venous thromboembolism / pre-existing diabetes / precocious puberty pituitary tumours / infection / Several cases reporting rhabdomyolysis / withdrawal symptoms / pointes/QT Prolongation Broad SMQ Myocarditis / tardive dyskinesia / acute renal failure / cataract / dehydration / / MedicalTreatment cataract surgery / / Organization KRKA Lab. / European Union / / Position specialist / / Product Invega / symptoms / Risperdal / risperidone / Ford RL / RISPERDAL CONSTA / furosemide / RPG / hepatic function / / Technology alpha / DLP / /
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EU PSUR Work Sharing Summary Assessment Report Risperdal (Consta) (risperidone) BE/H/PSUR[removed]P-RMS