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GRANUPAS (para-aminosalicylic acid), antituberculosis agent
INFECTIOUS DISEASES - New medicinal product
Opinions on drugs -
Posted on
Jan 21 2015
Reason for request
Inclusion
Minor clinical added value in combination with other antituberculosis agents in multidrug resistant tuberculosis when compared with the usual treatment
- GRANUPAS has Marketing Authorisation for multidrug resistant tuberculosis in combination with other antituberculosis agents. This is the first medicinal product with this indication.
- The WHO has included it in the treatment strategy for multidrug resistant tuberculosis in combination with several second-line antituberculosis agents.
- The evidence for its efficacy is based on a long experience in tuberculosis treatment and on the follow-up of a non-comparative cohort. The adverse effects, for the most part gastrointestinal or cutaneous, are not of a serious nature.
Clinical Benefit
| Substantial |
Substancial. |
Clinical Added Value
| minor |
Due to great need but poorly demonstrated efficacy in the treatment of MDR-TB, GRANUPAS (para-aminosalicylic acid) in combination with other TB medicines provides a minor improvement in actual benefit (level IV) in the treatment strategy for these patients. |
