OrphanDrug
OrphanDrug
Pharma Knowledge Base
ES

Spain

ES

Europe

Contents

  1. 1. Regulatory Overview
  2. 2. Regulatory Pathways
  3. 3. Available Drugs

Regulatory Overview

Spain is regulated by the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios). The country has 2 documented regulatory pathways for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.

Regulatory Authority

AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

Regulatory Pathways (2)

Uso Compasivo – Spain (Real Decreto 1015/2009) 30 days

Spanish compassionate use framework under Royal Decree 1015/2009 allowing access to medicines under investigation or not marketed in Spain for patients with serious or life-threatening conditions.

Application Form: AEMPS Compassionate Use Form
Legal Basis: Real Decreto 1015/2009
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: AEMPS Compassionate Use Guidance
Spain Compassionate Use (Article 83 EMA) 30 days

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Spain.

Application Form: National compassionate use form
Legal Basis: Regulated under EU Directive 2001/83/EC
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: EMA Article 83 Compassionate Use

Drugs Available (98)

DrugAccess RouteStatusLead Time
cytarabine———
Ataluren———
eribulin mesylate———
Sucralfate———
Memantine———
propranolol———
tamoxifen citrate———
ruxolitinib———
mycophenolate mofetil———
Epoprostenol———
Fludarabine———
etanercept———
dapsone———
mavacamten———
bosentan———
testosterone———
Rho(D) immune globulin———
triheptanoin———
loncastuximab tesirine———
melatonin———
amiodarone———
Total Parenteral Nutrition———
ascorbic acid———
hormone replacement therapy (estrogen/progesterone)———
Interferon-gamma———
physical therapy and orthotic management———
Retinoids (Tretinoin)———
eculizumab———
miglustat———
Betaine anhydrous———
Octreotide———
oxybutynin———
Valproic Acid———
tocilizumab———
Immunoglobulin———
alpha-L-iduronidase———
sirolimus———
temozolomide———
Carnitine———
brivaracetam———
Angiotensin-Converting Enzyme Inhibitors (Enalapril)———
idebenone———
botulinum toxin type A———
azathioprine———
L-carnitine———
luspatercept———
trabectedin———
vosoritide———
rituximab———
Dapagliflozin———
allopurinol———
Carboplatin———
Topical corticosteroids———
estradiol———
Tolvaptan———
cerliponase alfa———
avalglucosidase alfa———
atidarsagene autotemcel———
adalimumab———
tacrolimus ophthalmic———
Amphotericin B liposomal———
ranibizumab———
diacerein———
carglumic acid———
doxorubicin———
Levetiracetam———
Acitretin———
prednisone———
aflibercept———
laronidase———
Bleomycin———
hydroxycobalamin———
Metreleptin———
pregabalin———
N-acetylcysteine———
Pamidronate———
Diosmin———
ezetimibe———
bevacizumab———
mecasermin———
celecoxib———
Imiquimod———
Growth Hormone———
deferasirox———
Tafamidis———
Levodopa/Carbidopa———
Lanreotide———
baricitinib———
Azacitidine———
Zoledronic Acid———
emollients with keratolytics———
cornstarch———
Cisplatin———
imatinib mesylate———
nimodipine———
Colchicine———
surgical repair———
Hematopoietic stem cell transplantation———
ES
Spain
ISO CodeES
RegionEurope
Regulatory AuthorityAEMPS (Agencia Española de Medicamentos y Productos Sanitarios)
Pathways2 documented
Drugs Available98 drug(s)