INFARMED releases list of drugs subject to limited exportation rules

November 7 ,2013 | By Márcio Barra

Lyrica, one of the drugs subject to new exportation rules in Portugal

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


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