AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such...

div class=trans-pagebuttonPage 1button div class=trans-image amp-img class=trans-thumb alt=Page 1: AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such personnel This authorisation permits the authorisation holder to distribute by way src=https:reader030fdocumentsnetreader030viewer20220409115e9a5386681e3c1ef90eb9dfhtml5thumbnails1jpg width=142 height=106 layout=responsive amp-img divdivdiv class=trans-pagebuttonPage 2button div class=trans-image amp-img class=trans-thumb alt=Page 2: AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such personnel This authorisation permits the authorisation holder to distribute by way src=https:reader030fdocumentsnetreader030viewer20220409115e9a5386681e3c1ef90eb9dfhtml5thumbnails2jpg width=142 height=106 layout=responsive amp-img divdivdiv class=trans-pagebuttonPage 3button div class=trans-image amp-img class=trans-thumb alt=Page 3: AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such personnel This authorisation permits the authorisation holder to distribute by way src=https:reader030fdocumentsnetreader030viewer20220409115e9a5386681e3c1ef90eb9dfhtml5thumbnails3jpg width=142 height=106 layout=responsive amp-img divdivdiv class=trans-pagebuttonPage 4button div class=trans-image amp-img class=trans-thumb alt=Page 4: AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such personnel This authorisation permits the authorisation holder to distribute by way src=https:reader030fdocumentsnetreader030viewer20220409115e9a5386681e3c1ef90eb9dfhtml5thumbnails4jpg width=142 height=106 layout=responsive amp-img divdivdiv class=trans-pagebuttonPage 5button div class=trans-image amp-img class=trans-thumb alt=Page 5: AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such personnel This authorisation permits the authorisation holder to distribute by way...

AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such...

Documents

Transcript of AC-PHTOCOPIER2-20180808172902€¦ · The authorisation holder must provide and maintain such...

SCIENTIFIC DISCUSSION Marketing Authorisation Holder · It is presented as a canary yellow homogeneous clear solution, miscible with water. ... The bottle is closed with a polypropylene

GMP inspection system in the EEA - ema.europa.eu · Directives lay down three types of licence – Marketing authorisation • Holder must be established in EU/EEA • Authorisations

… · The authorisation holder must not sell or supply a medicinal product, or offer it for sale or supply, unless: there is a marketing authorisation, Article 126a authorisation,

Between - NMVO€¦ · Marketing Authorisation Holder: for the purpose of this paper this term relates to the entities that hold a marketing authorisation. Master Data - data related

CHMP extension of indication variation assessment report · Marketing authorisation holder (MAH): ... Alexion Europ e SAS submitted to the European Medicines Agency on 5 December

CHAPTER 1 MARKETING AUTHORISATION · DATA EXCLUSIVITY AND MARKET PROTECTION ... the applicant/marketing authorisation holder must submit an application in the Member States concerned

CHMP extension of indication variation assessment report€¦ · MAH Marketing authorisation holder MRI magnetic resonance imaging ... Biogen Idec Ltd submitted to the ... P/0252/2012

SCIENTIFIC DISCUSSION - European Medicines Agency€¦ · Advocate Marketing Authorisation Holder: Bayer HealthCare AG 51368 Leverkusen Germany Active substances: Imidacloprid & moxidectin

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, … · 5 Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Finland Merck

Annex I List of nationally authorised medicinal …...A. List of nationally authorised medicinal products recommended for suspension Member State in EEA Marketing authorisation holder

Cinacalcet Accordpharma, INN-cinacalcet...• Product name, strength, pharmaceutical form: Mimpara 30 mg, 60 mg and 90 mg film coated tablets • Marketing authorisation holder: Amgen

€¦ · The authorisation holder must provide and maintain such personnel, ... This authorisation permits the authorisation holder to distribute by way of wholesale dealing within

Amendment to Information of Authorised Signatory(ies) of ... › asia › vietnam › forms › ... · The Account Holder hereby confirms that the re-authorisation by the Chief Accountant

BENGALLA MINE MINING OPERATIONS PLAN 2017-2021 · Department means the NSW Department of Planning and Environment. Authorisation Holder means the holder of the relevant authorisation(s).

VORAPAXAR FOR THE REDUCTION OF THROMBOTIC … · · 2018-01-29Manufacturer/ Market Authorisation Holder [v1.3] Merck & Company, Inc / MSD Inc ... This drug evaluation must be understood

Marketing Authorisation Holder and ManufacturerGeneral dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07ml (7mg)

Care and Maintenance Mining Operations Plan€¦ · Name of Authorisation/Authorisation Holder(s): Shoalhaven Coal Pty Ltd Name of Mine Operator: Sedgman Limited Name and Contact

€¦ · Web viewNote: . the applicant of the present application must be the same as the marketing authorisation holder of the existing marketing authorisation . this section should

Undertaking to the Secretary of the Department of …...Mining Act. KEPCO Bylong Australia Pty Limited (ACN 075 361 769) (KEPCO) is the holder of Authorisation 342 (A342) and Authorisation

Procedure under Article 5(3) of Regulation EC (No) 726 ... - …€¦ · MA Marketing Authorisation . MAH Marketing Authorisation holder . Methyl-CCNU 1-(2-Chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea