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who summary of product characteristics ?

  • Listed: 14 September 2021 2 h 30 min

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https://extranet.who.int/pqweb/sites/default/files/documents/WHO_SMPC_azd1222.pdf

PDF Who Summary of Product Characteristics
https://extranet.who.int/pqweb/sites/default/files/documents/WHO_SMPC_azd1222.pdf
Demographic characteristics were generally similar among participants who received COVID-19 Vaccine AstraZeneca and those who received control. Overall, among the participants who received COVID-19 Vaccine AstraZeneca, 90.3% were aged 18 to 64years and 9.7% were 65years of age or older.

https://extranet.who.int/pqweb/sites/default/files/documents/109 SmPC template_Oct2016_0.docx

DOCX Summary of Product Characteristics
https://extranet.who.int/pqweb/sites/default/files/documents/109 SmPC template_Oct2016_0.docx
SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) TEMPLATE. Should the product to which a completed . summary of product characteristics (SmPC) be prequalified, it . will form Part 4 of the WHO Public Assessment Report that will be posted on the website of the WHO Prequalification Team: medicines

https://www.ema.europa.eu/en/glossary/summary-product-characteristics

Summary of product characteristics | European Medicines Agency
https://www.ema.europa.eu/en/glossary/summary-product-characteristics
Summary of product characteristics A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively.

https://www.ema.europa.eu/en/documents/product-information/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-product-information_en.pdf

PDF Annex I Summary of Product Characteristics
https://www.ema.europa.eu/en/documents/product-information/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-product-information_en.pdf
SUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section4.8 for how to report adverse reactions. NAME OF THE MEDICINAL PRODUCT

https://en.wikipedia.org/wiki/Summary_of_Product_Characteristics

Medication package insert – Wikipedia
https://en.wikipedia.org/wiki/Summary_of_Product_Characteristics
In the European Union, the European Medicines Agency has jurisdiction and the relevant documents are called the summary of product characteristics (SPC or SmPC) and the document for end-users is called the patient information leaflet or package leaflet.

https://gskpro.com/content/dam/global/hcpportal/en_MT/PDF/Homepage/Products/augmentin/augmentin-duo-mixed-fruit-malta-spc-dec-2019.pdf

PDF Summary of Product Characteristics
https://gskpro.com/content/dam/global/hcpportal/en_MT/PDF/Homepage/Products/augmentin/augmentin-duo-mixed-fruit-malta-spc-dec-2019.pdf
SUMMARY OF PRODUCT CHARACTERISTICS . 2 . 1. NAME OF THE MEDICINAL PRODUCT. Augmentin Duo 400 mg/57 mg/5 ml powder for oral suspension (mixed fruit flavour) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 80 mg

https://e-ecodent.gr/images/ProductsInfo/SEPTODONT/septanest1_100.pdf

PDF Summary of Product Characteristics
https://e-ecodent.gr/images/ProductsInfo/SEPTODONT/septanest1_100.pdf
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SEPTANEST 1:100,000 ARTIKENT 1:100,000 (Own label for Kent Express) BARTINEST 1:100,000 ISONEST 1:100,000 (Own label for Henry Schein Procare) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per cartridge 1.7 ml 2.2 ml Articaine hydrochloride 68.000 mg 88.000 mg

https://www.ema.europa.eu/en/documents/product-information/rukobia-epar-product-information_en.pdf

PDF Annex I Summary of Product Characteristics
https://www.ema.europa.eu/en/documents/product-information/rukobia-epar-product-information_en.pdf
SUMMARY OF PRODUCT CHARACTERISTICS . 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

https://www.medicines.org.uk/emc/

Home – electronic medicines compendium (emc)
https://www.medicines.org.uk/emc/
The most up to date, comprehensive, regulated information about medicines. Easy to use, trusted and recommended by healthcare professionals

https://www.medicines.org.uk/emc/product/5760/smpc

Sertraline 50mg tablets – Summary of Product …
https://www.medicines.org.uk/emc/product/5760/smpc
Sertraline 50mg tablets. This information is intended for use by health professionals. 1. Name of the medicinal product. Sertraline 50 mg film-coated tablets. 2. Qualitative and quantitative composition. Each film-coated tablet contains 50 mg sertraline (as sertraline hydrochloride).

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