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)
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… · 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,
Bexsero, common name - meningococcal group B Vaccine (rDNA, … · accordingly. In addition, the Marketing authorisation holder (MAH) took the opportunity to make some 26/03/2020
ANNEX II THE MANUFACTURING AUTHORISATION HOLDER ...ec.europa.eu/health/documents/community-register/1998/199807243143/anx_3143_en.pdfTHE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE
Guidance document concerning the parallel trade …...certificate is the authorisation holder rather than the manufacturing company that is simply following the instructions supplied
· Web viewThe holder of a type-certificate, restricted type-certificate, supplemental type-certificate, European Technical Standard Order (ETSO) authorisation, major repair design
The biosimilar medicines decalogue · countries of the European Economic Area (EEA), paved the way in creating ... the marketing authorisation holder (MAH) must incorporate an explicit
ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL … · 2 Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of administration Austria
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
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).
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, … · 5 Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Finland Merck
Public Version Application for Authorisation · The NPSA is a peak industry body representing pharmaceutical wholesalers in Australia. NPSA Members distribute to all pharmacies and
Annex I List of the names, pharmaceutical forms, strengths ...ec.europa.eu/health/documents/community-register/2014/20140901… · Applicant/Marketing Authorisation Holder ; Product
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
€¦ · 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
CHAPTER 1 MARKETING AUTHORISATION · DATA EXCLUSIVITY AND MARKET PROTECTION ... the applicant/marketing authorisation holder must submit an application in the Member States concerned
€¦ · 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,
