Israel - English - Ministry of Health

medison pharma ltd - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 30 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

Israel - English - Ministry of Health

incyte biosciences israel ltd, israel - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 45 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

Israel - English - Ministry of Health

incyte biosciences israel ltd, israel - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 45 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

Israel - English - Ministry of Health

medison pharma ltd - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 45 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

Israel - English - Ministry of Health

medison pharma ltd - ponatinib as hydrochloride - coated tablets - ponatinib as hydrochloride 45 mg - ponatinib - iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation • philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.

Namibia - English - Namibia Medicines Regulatory Council

novartis (sa) (pty) ltd - nilotinib hydrochloride - capsule - each capsule contains nilotinib hydrochloride monohydrate equivalent to nilotinib base 200 mg

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - nilotinib hcl monohydrate eqv to nilotinib - capsule - nilotinib hcl monohydrate eqv to nilotinib 50mg

Canada - English - Health Canada

pharmascience inc - buprenorphine (buprenorphine hydrochloride); naloxone (naloxone hydrochloride dihydrate) - tablet - 2mg; 0.5mg - buprenorphine (buprenorphine hydrochloride) 2mg; naloxone (naloxone hydrochloride dihydrate) 0.5mg - opiate partial agonists

Canada - English - Health Canada

pharmascience inc - buprenorphine (buprenorphine hydrochloride); naloxone (naloxone hydrochloride dihydrate) - tablet - 8mg; 2mg - buprenorphine (buprenorphine hydrochloride) 8mg; naloxone (naloxone hydrochloride dihydrate) 2mg - opiate partial agonists

Canada - English - Health Canada

teva canada limited - naloxone (naloxone hydrochloride dihydrate); buprenorphine (buprenorphine hydrochloride) - tablet - 0.5mg; 2mg - naloxone (naloxone hydrochloride dihydrate) 0.5mg; buprenorphine (buprenorphine hydrochloride) 2mg - opiate partial agonists