Annex to newsletter regarding the BPTO Resolution
The full list of products considered strategic by Ministry of Health and neglected diseases is discriminated in ordinances No. 978/2008 and No. 1284/2010 of Ministry of Healthy and Annex 1 of Resolution 80/2013. I. Pharmaceutical segment 1. Antiviral (including antiretroviral): Atazanavir Darunavir Efavirenz Enfuvirtide Entecavir Lopinavir Raltegravir Ritonavir Tenofovir 2. Related to neglected diseases Liposomal Amphotericin B Meglumine antimoniate Artesunate Benznidazole Clofazimine Chloroquine Dapsone Amphotericin B deoxycholate Ethambutol Ethionamide Isoniazid Mefloquine Nifurtimox Pyrazinamide Praziquantel Primaquine Rifabutin Rifampicin 3. Related to not transmissible chronic disease (Alzheimer) Donepezil Rivastigmine
(antipsychotics and anticonvulsants)
(antirheumatic and anti-inflammatory)
Mesalazine (Immunosuppressive) Everolimus Mycophenolate mofetil Mycophenolate sodium Tacrolimus Sirolimus (osteoporosis) Calcitonin Calcitriol Raloxifene (pulmonary arterial hypertension) Iloprost Sildenafil (other indications) Bromocriptine Sevelamer hydrochloride Statins Glatiramer Riluzole Somatostatin 4. Products obtained by biological routes: (Monoclonal Antibodies) Adalimumab Dasatinib Imatinib Infliximab Nilotinib Rituximab Trastuzumab Others (enzimes) Alpha dornase Glucocerebrosidase Others (hormones) Insulin-like growth factor (IGF-1) Filgrastim Human chorionic gonadotrophin (HCG) and Pregnant mare's serum gonadotropin (PMSG) Goserelin Glucagon Follicle stimulating hormone Insulin Leuprorelin Somatotropin Others (proteins) Etanercept Procoagulant factors Interferons Octreotide Botulinum toxin Others 5. Vaccines and blood products 6. Medicines and supplies for the therapy of disorders resulting from nuclear accidents II. Segment of medical devices and general devices of support health
Category I - Medical Devices
1. Active medical product for diagnosis
A) Diagnostic imaging equipment
Flexible and Rigid Endoscopy Equipment
Ultrasound diagnostic equipment
B) Equipment for in vitro and in vivo diagnostics
Equipment that directly generates results for in vitro
2. Active medical product for therapy
A) Dialysis equipment
Hemodialysis equipment and accessories,
B) Equipment for general therapy
Individual hearing aids (hearing aid)
3. Implantable medical Product
A) implantable device
Cochlear implant with electric generator
Pacemaker, defibrillator and Cardioconversor
Implantable device/ Material / article
Intrauterine device (IUD)
Vena cava filter
Cochlear implants with mechanical components only
Hip and knee prosthesis with porous coating technology
applied to its surface
Coronary stent
4. Active medical product for physician-hospital support
A) refrigerated centrifuge for blood bag
B) freezer /ultralow temperature conservative for
samples, blood, vaccines
C) simulators for diagnostic imaging equipment
5. Non active medical product for physician-hospital
A) bag for collection and storage of human blood
B) dialyzers, needles fistulas and thread for hemodialysis
C) medical devices used for contraception or to prevent
the transmission of sexually transmitted diseases
D) Surgical and procedure synthetic gloves
6. Diagnostic products for use in vivo
A) diagnostic kits for detection of diseases and supplies
for their production
Chagas disease
West Nile virus
Brazilian spotted fever
Cutaneous leishmaniasis
Visceral leishmaniasis
Category II – general devices for health support
Equipment for testing and evaluation of the safety and
performance of electrical apparatus under the health surveillance regime, according to specifications of the standard series ABNT NBR IEC 60601 Category III – neglected diseases Chagas disease Dengue Schistosomiasis Leprosy Leishmaniosis Malaria Tuberculosis Buruli ulcer Neurocysticercosis Echinococcosis Bouba Fascioliasis Paragonimiasis Filariasis Rabies Helminthiasis and Manifestations resulting from intoxication or poisoning due to poisonous or venomous animals.

Source: http://www.diblasi.com.br/download/Annex%20to%20newsletter%20regarding%20the%20BPTO%20Resolution%20802013.pdf

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