November 7 ,2013 | By Márcio Barra
INFARMED, the Portuguese National Competent Authority, has adopted a list of drugs whose export or outside distribution will depend on prior notification, in an effort to prevent Portuguese patients of being deprived of adequate therapy. Drugs in the list include Teva’s Parkinson’s disease drug Azilect, Pfizer’s painkiller Celebrex and Astrazeneca statin Crestor (full list after the break).
The decision, published yesterday in the “Diário da República”, states that while “the export and distribution of medicines for other member states of the European Union is a legal activity when exercised by manufacturers or wholesale distributors of medicinal products”, excessive exportation is “likely to create constraints to the supply of the Portuguese domestic market, depriving patients of medicines”. This initiative follows a decision published in Tuesday, obliging laboratories , wholesalers, pharmacies and distributors to report monthly to INFARMED the quantities of drugs included in this list that have been sold.
The list, released by INFARMED to ensure that the Portuguese market stays adequately supplied, details all drugs whose export or distribution to other member states of the European Union are subject to prior notification to this body by the distributor. The medicines are selected according to appropriateness and necessity criteria.
This decision enters into force today, although a transitional period of adaptation will be in place until the 31st of December.
The list of Drugs included in the List.
Abilify (Aripiprazol) – Otsuka Pharmaceutical Europe Ltd.
Aggrenox (Acetylsalicylic acid + Dipiridamol ) – Unilfarma
Alzen SR (Quetiapine) – AstraZeneca
Arthrotec 75 (Diclofenac + Misoprostol) – Pfizer
Assieme Turbohaler (Budesonide + Formoterol) – AstraZeneca
Atarax (Hydroxyzine) – UCB Pharma
Atrovent PA (Ipratropium bromide) – Unilfarma
Atrovent Unidose (Ipratropium bromide) – Unilfarma
Avamys (Fluticasone furoate) – Glaxo Group Limited
Azilect (Rasagiline) – Teva Pharma GmbH
Biloban (Ginkgo biloba) – Laboratórios Atral
Celebrex (Celecoxib) – Pfizer
Cialis (Tadalafil) – Eli Lilly
Cipralex (Escitalopram) – H. Lundbeck A/S
Crestor (Rosuvastatin) – AstraZeneca
Ebixa (Memantine) – H. Lundbeck A/S
Eufilina (Theophylline) – Takeda
Eutirox (levothyroxine) – Merck, S.A.
Gonal –F (Follicle-stimulating hormone) – Merck Serono
Humalog (Insulin lispro) – Eli Lilly
Insulatard Penfill (isophane Insulin) – Novo Nordisk
Jaba B12 (Cobamamide) – Jaba Recordati
Keppra (Levetiracetam) – UCB Pharma
Levemir (Detemir Insulin) – Novo Nordisk
Lioresal (Baclofen) – Novartis
Lovenox (Enoxaparin) – Sanofi
Lyrica (Pregabaline) – Pfizer
MicardisPlus (Telmisartan and hydrochlorothiazide) – Boehringer Ingelheim
Mixtard 30 Penfill (Soluble insulin + soluble) – Novo Nordisk
NovoMix 30 Penfill (Insulin aspart protamine) – Novo Nordisk
Nuvaring (Etonogestrel and ethinyl estradiol) – Merck Sharp & Dohme,
Ovestin (Estriol) – Merck Sharp & Dohme
Pulmicort (Budesonide) – Astrazeneca
Risperdal Consta (Risperidone) – Janssen
Sandimmun Neoral (Cyclosporine) – Novartis
Seretide Diskus (Fluticasone and salmeterol) – Glaxo Wellcome
Seretaide Inhalor (Fluticasone and salmeterol) – Glaxo Wellcome
Seroquel SR (Quetiapine) – AstraZeneca
Singulair (Montelukast) – Merck Sharp & Dohme
Solexa (Celecoxib) – Medinfar Labs
Spiriva (Tiotropium Bromide) – Boehringer Ingelheim
Symbicort Turbohaler (Budesonide and formoterol) – AstraZeneca
Tegretol CR (Carbamazepina) – Novartis
Thyrax (Levothyroxine sodium) – Merck Sharp & Dohme
Trivastal 50 Retard (Piribedil) – Servier Portugal
Visacor (Rosuvastatina) – AstraZeneca
Zonegran (Zonisamide) – Eisai