The Human Medicines Regulations 2012 – …

The Human Medicines Regulations 2012 – description of each Part This document provides a brief overview of each Part of the Human Medicines Regulations 2012 …

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FULTIUM -D 800 IU CAPSULES - GOV.UK

Vitamin D deficiency, with levels of 25(OH)D below 25nmol/L (10ng/ml), could result in the disease rickets (or osteomalacia). The disease resulting as a deficiency is considered to be due to malabsorption

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GLYCOPYRRONIUM BROMIDE 0.2MG/ML …

UKPAR Glycopyrronium Bromide 0.2 mg/ml Solution for Injection PL 00156/0115 1 GLYCOPYRRONIUM BROMIDE 0.2MG/ML SOLUTION FOR INJECTION (PL 00156/0115)

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Meloxicam - GOV.UK

PL 31388/0003-4 UKPAR Alpex Pharma (UK) Ltd, Meloxicam 7.5mg and 15mg Orodispersible Tablets 3 Scientific Discussion INTRODUCTION Based on the review of the data on quality, safety and efficacy, the UK granted

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PL 00010/0643 - GOV.UK

UKPAR Canesten HC Cream PL 00010/0643 6 All excipients comply with their respective European Pharmacopoeia monographs, except triceteareth-4-

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Public Assessment Report UKPAR Canesten Combi …

This is a summary of the Public Assessment Report (PAR) for Canesten Combi Pessary & External Cream 500mg / 2% w/w pessary & cream (PL 00010/0653).

DCPAR for Ampicillin-Salbactam 1 g--0 5 and 2 g-1 g ...

PAR Ampicillin/Sulbactam 1 g/0.5 g and 2 g/1 g powder for Solution for Injection or Infusion UK/H/4322/001-2/DC 1 Public Assessment Report Decentralised Procedure

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Public Assessment Report Mutual Recognition …

PAR Sayana 104mg/0.65ml Suspension for Injection UK/H/0960/001/MR 1 Public Assessment Report Mutual Recognition Procedure SAYANA 104MG/0.65ML SUSPENSION FOR INJECTION

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Cefixime 400 mg Film-coated Tablets, PL 22805 …

MHRA PAR; CEFIXIME 400 MG FILM-COATED TABLETS, PL 22805/0032-3 2 Lay summary The Medicines and Healthcare products Regulatory Agency …

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Public Assessment Report Decentralised Procedure …

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Optimizing Drug Registration in China: Category I …

OPTIMIING DRUG REGISTRATION IN CHINA: CATEGORY I ROUTE 6 Category I New Drug Application Given the limitations of the category III IDL route, some developers are exploring the alternative—pursu-

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New Zealand Datasheet Name of Medicine - Medsafe

1 . New Zealand Datasheet . Name of Medicine . Duolin ® Salbutamol / Ipratropium bromide . Presentation . Inhaler: 100 mcg / 20 mcg per inhalation; 200 doses

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Government response to the UK Early Access to …

1 . Government response to the UK Early Access to Medicines Scheme consultation – March 2014

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December 2017 Issue 23 – Special China Edition

termsheet December 2017 Issue 23 – Special China Edition Heads of Terms Changes in China Investment in biotech and pharmaceuticals continues to change in China and at PharmaVentures we have seen

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A Beginners Guide to FDA Legislation of Food …

Smithers Pira the worldwide authority on the packaging, paper and print industry supply chains A Beginners Guide to FDA Legislation of Food Contact Materials Dr Alistair Irvine, Smithers Pira

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XHANCE™ Full Prescribing Information

FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE XHANCE™ nasal spray is indicated for the treatment of nasal polyps in patients 18 years of age or older.