Why look at an SPC?

Drug and Therapeutics Bulletin

Volumn 47, Issue 5, 2009, Pages 56-58

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Author keywords

[No Author keywords available]

Indexed keywords

AZTREONAM; BIMATOPROST PLUS TIMOLOL; CARVEDILOL; CREATININE; ENALAPRIL; ENALAPRIL MALEATE; ROSUVASTATIN; SIMVASTATIN; DRUG;

ARTICLE; CLINICAL PRACTICE; CREATININE BLOOD LEVEL; DRUG INFORMATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; FOOD DRUG INTERACTION; GRAPEFRUIT JUICE; HUMAN; PRACTICE GUIDELINE; SIDE EFFECT; UNITED KINGDOM; CHEMISTRY; DRUG APPROVAL; DRUG DESIGN; DRUG LABELING; DRUG TOXICITY; LEGAL ASPECT;

CHEMISTRY, PHARMACEUTICAL; DRUG APPROVAL; DRUG DESIGN; DRUG LABELING; DRUG TOXICITY; PHARMACEUTICAL PREPARATIONS;

EID: 77649222007     PISSN: 00126543     EISSN: None     Source Type: Journal    
DOI: 10.1136/dtb.2009.04.0016     Document Type: Article

References (6)

1. European Commission, 2001. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [online]. Available: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir-2001-83-cons/ dir2001-83-cons-20081230-en.pdf [Accessed 22 April 2009].
2. European Commission, 2005. Notice to applicants: a guideline on summary of product characteristics [online]. Available: http://ec.europa.eu/ enterprise/pharmaceuticals/eudralex/vol-2/c/spcguidrev1-oct2005.pdf [Accessed 22 April 2009].
3. Failings in treatment advice, SPCs and black triangles. DTB 2001; 39: 25-7.
4. Medicines and Healthcare Products Regulatory Agency. Off label use or unlicensed medicines: prescribers' responsibilities. Drug Safety Update [online] 2009; 2 (9): 6-7. Available: http://www.mhra.gov.uk/Publications/ Safetyguidance/DrugSafetyUpdate [Accessed 22 April 2009].
5. Wall AJ et al. Variability in the quality of overdose advice in summary of product characteristics (SPC) documents: gut decontamination recommendations for CNS drugs. Br J Clin Pharmacol 2009;67: 83-7.
6. The Association of the British Pharmaceutical Industry. Code of practice for the pharmaceutical industry 2008 [online]. Available: http://www.abpi.org.uk/publications/pdfs/pmpca-code2008.pdf [Accessed 22 April 2009].