Summary of product characteristics mhra








SOP for development of an Investigator Brochure or IMP dossier

10/23/2014
05:33 | Author: Steven Lewis

Summary of product characteristics medicine
SOP for development of an Investigator Brochure or IMP dossier

Investigational Medicinal Product (IMP) information for the MHRA/EU is the Summary of Product Characteristics (SmPC) may be provided instead of an IMPD.

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Urinary-tract infections - (05.01.13) - Leeds Formulary Formulary

12/22/2014
03:06 | Author: Allison King

Summary of product characteristics medicine
Urinary-tract infections - (05.01.13) - Leeds Formulary Formulary

Manufacturer's information on prescribing is available via the MHRA website (see link below); NHS Leeds Traffic Summary of Product Characteristics (MHRA).

Traffic Light Status Information.

The following antibiotics are included within the Antimicrobial Prescribing Guidelines, which can be found via the Antimicrobial Resource Page. Antibiotics are only considered to be formulary items when used in line with these guidelines.

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Article MHRA consults on plans to simplify drug ads - PharmaTimes

10/21/2014
01:41 | Author: Steven Lewis

Summary of product characteristics medicine
Article MHRA consults on plans to simplify drug ads - PharmaTimes

C: authorisation of a link to the full Summary of Product Characteristics (SPC) in electronic ads as an alternative to the prescribing information.

available for iOS, Android and web Lynne Taylor.

PharmaTimes 2014| RSS Feed Subscriptions.

Currently, abbreviated ads which include a pointer rather than the prescribing information are only permitted for small-size ads appearing in journals and similar publications, but proposals put to the MHRA Red Tape Challenge in 2012 called for the abbreviated ad format to be more widely used. The Agency is consulting on the following three options put forward by industry: • A: extending the use of the abbreviated ad format to all general sale list (GSL) medicines: • B: extending use of the format to medicines that have been on retail sale through pharmacies for a minimum defined period; and • C: authorisation of a link to the full Summary of Product Characteristics (SPC) in electronic ads as an alternative to the prescribing information.

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Sucampo Receives Notice that Second Indication for AMITIZA for

8/20/2014
01:08 | Author: Jeremy Rodriguez

Summary of product characteristics medicine
Sucampo Receives Notice that Second Indication for AMITIZA for

In 2012, the MHRA approved AMITIZA for the treatment of chronic submission to update the Summary of Product Characteristics (SPC) for.

About Sucampo Pharmaceuticals, Inc.

This symptom generally resolves within three hours, but may recur with repeat dosing. Patients taking AMITIZA may experience dyspnea within an hour of first dose. Patients who experience dyspnea should inform their HCP. Some patients have discontinued therapy because of dyspnea.

Reduce the dosage in IBS-C patients with severe hepatic impairment. Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment.

Patients taking AMITIZA may experience nausea.

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Digoxin - mhra - rcs - Search Results - Evidence Search - Search

6/19/2014
03:05 | Author: Molly Young

Summary of product characteristics medicine
Digoxin - mhra - rcs - Search Results - Evidence Search - Search

Results 1 - 10 The relevant summaries of product characteristics (SPCs) for Digoxin. Leaflet Page 24 Labelling Page 26 MHRA PAR –Digoxin 62.5 micrograms.

...who will take a PPI concomitantly with digoxin or drugs that may cause hypomagnesaemia...especially for those who take PPIs with digoxin or drugs that may cause hypomagnesaemia...who will take a PPI concomitantly with digoxin or drugs that may cause hypomagnesaemia.

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Medicines and Healthcare products Regulatory Agency, 08 June 2012.

Medicines and Healthcare products Regulatory Agency, 14 December 2011.

.standard therapies, e.g. diuretics, digoxin, and ACE inhibitors in patients with euvolemia.standard therapies e.g.

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