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Public Assessment Report Decentralised Procedure …

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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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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).

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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CMD(h) BEST PRACTICE GUIDE ON THE …

BPG on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures Rev.5, November 2008 Page 1/11 CMD(h) BEST PRACTICE GUIDE

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Quick Response (QR) codes in the labelling and/or …

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All About Regulatory Affairs - Granzer

9 Application to first member state Assessment report including SPC, PIL First Authorization: RMS 210 days Applicant request on mutual recognition of first

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Commission Regulation (EU) No 712/2012 of 3 …

COMMISSION REGULATION (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of

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Packaging ‘blue-box’ requirements and additional ...

CMDv GUI-027 _ addition CP EMA/CMDv/391895/2012 Page 1 of 35 . CMDv-GUI-27 . EMA/CMDv/391895/2012 . Version 22/12/2014 . Packaging ‘blue-box’ requirements and additional information on

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ICH and EU regulatory framework and the role of …

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QRD Human Product Information Template

2 - English language version: immediately after adoption of the opinion. - All other language versions: at the latest 25 days after adoption of the opinion (i.e. at the

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eCTD Guidance Document - Europa

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NOTICE TO ASMF HOLDERS FOR ELECTRONIC …

ANSM – 11/2017 Page 1 sur 6 www.ansm.sante.fr NOTICE TO ASMF HOLDERS FOR ELECTRONIC SUBMISSION OF ASMF TO ANSM VIA CESP ..... 2

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