Revisado por Isabelle Baião de Mello Neto (CRF-MG 24309)Dizeres Legais do Zedora
M.S - 1.0033.0199
Farm. Resp.:
Cintia Delphino de Andrade
CRF-SP nº 25.125
Fabricado por:
Biocon Biologics Limited.
Block No. B1, B2, B3, Q13 of Q1 and W20 and Unit S18, 1st Floor, Block B4, Special Economic Zone, Plot No. 2, 3, 4, & 5, Phase IV
Bommasandra-Jigani Link Road
Bommasandra Post
Bengaluru – 560 099, India
Importado por:
Libbs Farmacêutica Ltda.
Avenida Marquês de São Vicente, 2219 - 2° andar – São Paulo – SP
CNPJ 61.230.314/0001-75
Embalado por:
Libbs Farmacêutica Ltda.
Rua Alberto Correa Francfort, 88
Embu das Artes - SP
Uso restrito a hospitais.
Venda sob prescrição médica.
Referências Bibliográficas
1. MYL-1401O (a proposed biosimilar to trastuzumab). Summary of Clinical Safety.
2. MYL-1401O (a proposed biosimilar to trastuzumab). Summary of Biopharmaceutic Studies and Associated Analytical Methods.
3. MYL-1401O (a proposed biosimilar to trastuzumab). Clinical Overview.
4. MYL-1401O (a proposed biosimilar to trastuzumab). Summary of Clinical Efficacy.
5. MYL-1401O (a proposed biosimilar to trastuzumab). Summary of Clinical Pharmacology.
6. Bula Herceptin aprovada no FDA. SUPPL-5330 - 17/03/2016.
7. Bula do profissional da saúde de Herceptin® aprovada pela ANVISA em07/06/2017.