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Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets



Mylan Pharmaceuticals LimitedEU/1/16/1133/001-006

Main Information

Trade NameEmtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets
Active SubstancesEmtricitabine
Tenofovir disoproxil
Dosage FormFilm-coated tablet
Licence HolderMylan Pharmaceuticals Limited
Licence NumberEU/1/16/1133/001-006

Group Information

ATC CodeJ05AR Antivirals for treatment of HIV infections, combinations
J05AR03 tenofovir disoproxil and emtricitabine

Status

License statusAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Checklist for Prescribers
Prescriber’s Brochure

Educational Materials - Patient

Patient Brochure
Patient Reminder Card

Generics Information

Interchangeable ListEmtricitabine/Tenofovir disoproxil 200 mg/245 mg Film-coated Tablets
Interchangeable List CodeIC0107-165-003
Interchangeable List DocumentPDF of Interchangeable List
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