WebApr 4, 2024 · Criteria for a Multilingual Package: The product name and its strength must be same in all the languages. The labeling and package leaflet information must be in accordance with the Summaries of Product Characteristics (SmPC). Information printed on the labeling and package leaflet must be accurate and legible. WebSee section 4.8 of the Summary of Product Characteristics (SmPC) for how to report adverse reactions VITRAKVI 25 mg / 100 mg hard capsules, VITRAKVI 20 mg/mL oral solution (Larotrectinib) Refer to full SmPC …
Imnovid (pomalidomide) Prescribing Information Table of …
WebIreland Dermatology Adtralza ® (tralokinumab) SmPC and PIL Dovobet ® gel (calcipotriol + betamethasone dipropionate) SmPC and PIL Dovonex ® cream (calcipotriol) SmPC and PIL Dovonex ® ointment (calcipotriol) SmPC and PIL Enstilar ® cutaneous foam (calcipotriol+ betamethasone dipropionate) SmPC and PIL Fucibet ® cream WebThis site contains Northern Ireland-specific medicines information for healthcare professionals and patients. Following Brexit, medicines used in Northern Ireland can either be approved by the European Medicines Agency (EMA) or the UK's Medicines & Healthcare products Regulatory Agency (MHRA). ... SmPC. Updated. Xolair 150 mg solution for ... cj001 カテゼリー
Robitussin Chesty Cough Medicine - Summary of Product …
WebJan 1, 2024 · The Northern Ireland MHRA Authorised Route (NIMAR) 20 September 2024 Guidance Importing medicines into Northern Ireland 16 March 2024 Guidance Supplying investigational medicinal products to... WebA. Vogel Ireland Ltd, SPC PIL IPAR: Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets Film-coated tablet Compare: PA0577/193/001 Authorised: 07/10/2016 McDermott Laboratories Ltd., T/A Gerard Laboratories: SPC PIL: Abacavir/Lamivudine Mylan Pharma Film-coated tablet Compare: PA0577/216/001 Authorised: 10/11/2024 WebThe HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent … Medicines Shortages - Find a medicine - HPRA Generic / Interchangeable List - Find a medicine - HPRA About Us - Find a medicine - HPRA ATC Codes - Find a medicine - HPRA Regulatory Information - Find a medicine - HPRA Merck Sharp & Dohme Ireland SmPC PIL : Synflorix (EU/1/09/508/1-9) … Veterinary Medicines Information - Find a medicine - HPRA Publications & Forms - Find a medicine - HPRA Contact Us - Find a medicine - HPRA News and Events - Find a medicine - HPRA cj010 ブラック