Misoprostol (1) – Angusta®
Labor induction
Characteristics
| Start date | 01.09.2021 – Marketing authorisation: 14.09.2020 |
|---|---|
| Resolution | 17.02.2022 |
| INN | Misoprostol |
| Brand name | Angusta® |
| Pharm. company | Norgine GmbH |
| G-BA Procedure ID | D-730 |
| ATC code | G02AD06 Prostaglandins (G02AD) |
| ICD-10 codes (AIS) | O10.0Any condition in I10 specified as a reason for obstetric care during pregnancy, childbirth or the puerperium, O10.1Any condition in I11 specified as a reason for obstetric care during pregnancy, childbirth or the puerperium, O10.2Any condition in I12 specified as a reason for obstetric care during pregnancy, childbirth or the puerperium, O10.3Any condition in I13 specified as a reason for obstetric care during pregnancy, childbirth or the puerperium, O10.4Any condition in I15 specified as a reason for obstetric care during pregnancy, childbirth or the puerperium, O11Pre-existing hypertension with pre-eclampsia, O14.0Mild to moderate pre-eclampsia, O14.1Severe pre-eclampsia, O14.2Severe pre-eclampsia with hemolysis, elevated liver enzymes and low platelet count (HELLP), O14.9Unspecified pre-eclampsia, O15.1Eclampsia complicating labor, O24.0Juvenile onset diabetes mellitus, in pregnancy, childbirth and the puerperium, O24.1Insulin-resistant diabetes mellitus in pregnancy, childbirth and the puerperium, O24.2, O24.3Unspecified pre-existing diabetes mellitus in pregnancy, childbirth and the puerperium, O24.4Diabetes mellitus arising in pregnancy, O24.9Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium, O26.60, O40Polyhydramnios, O41.0Oligohydramnios without rupture of membranes, O41.9Disorder of amniotic fluid and membranes, unspecified, O42.11Preterm premature rupture of membranes, onset of labor more than 24 hours following rupture, first trimester, O42.12Premature rupture of membranes at or after 37 completed weeks of gestation, onset of labor more than 24 hours following rupture, O48Late pregnancy, O62.0Failure of cervical dilatation, O62.1Arrested active phase of labor, O62.2Other uterine inertia, P05.2Newborn affected by fetal (intrauterine) malnutrition not light or small for gestational age, P05.9Newborn affected by fetal growth retardation NOS |
| Alpha-ID codes (AIS) | I101167Diabetes mellitus existing before pregnancy due to malnutrition or malnutrition, I108398Pregnancy with HELLP (hemolysis, elevated liver function test, low platelet counts) syndrome, I108402Oligohydramnios during pregnancy, I108408Pre-eclampsia during pregnancy, I109114Pregnancy with hypertensive heart and kidney disease, pre-existing, I115959Cholestasis during pregnancy, I116220Hypertensive kidney disease in pregnancy, pre-existing, I119464Plugged preeclampsia in chronic hypertension, I20263Polyhydramnios, I20677Mild pre-eclampsia, I30918Premature rupture of membranes with onset of labor after more than 7 days, I7767Benign essential hypertension in pregnancy, pre-existing, I7769Pre-existing heart disease with hypertension during pregnancy, I7779Severe pre-eclampsia, I7787Eclampsia at birth, I7854Diabetes mellitus during pregnancy, I7860Pre-existing diabetes mellitus during pregnancy, I7861Diabetes mellitus during pregnancy, occurring during pregnancy, I8127Transferred pregnancy, I81335Amniotic fluid disorder, I8137Primary weakness in labor, I8140Secondary labor weakness, I8490Fetal malnutrition, I8496Intrauterine deficiency development, I87561Premature rupture of membranes with onset of labor after 24 hours, I91521Labor weakness as a delivery complication, I95842Pregnancy with pre-existing renal hypertension after kidney disease, I99178Type 1 diabetes mellitus during pregnancy, pre-existing, I99179Type 2 diabetes mellitus during pregnancy, pre-existing |
| DDD | 0.2 mg O |
| Therapeutic area | Other diseases Induction of labour |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
| Therapeutic indication of the resolution |
|---|
|
Angusta is used for induction of labor. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Pregnant women with indication for induction of birth with immature cervix (Bishop score < 7). | Dinoproston |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
- Clinical trials
- The Young 2020 study was an open-label, three-arm RCT conducted between 1999 and 2000.
- The study compares orally administered misoprostol with vaginally administered misoprostol and with dinoprostone.
Pregnant women with an indication for labour induction due to cervical immaturity (Bishop score < 7)
- An additional benefit is not proven.
- Overall, it is concluded that additional benefit for misoprostol in pregnant women with an indication for labour induction due to cervical immaturity (Bishop score < 7) is not proven.
- morbidity
- In summary, it must be noted that the study presented (Young 2020) does not adequately represent either the intervention used or the appropriate comparator therapy that are relevant to the present benefit assessment.
- Health-related quality of life
- In summary, it must be noted that neither the intervention nor the comparator therapy used in the presented study (Young 2020) are suitable for adequately representing the intervention and appropriate comparator therapy relevant to the present benefit assessment.
- Side effects
- In summary, it must be noted that neither the intervention nor the comparator therapy used in the submitted study (Young 2020) are suitable for adequately representing the intervention and appropriate comparator therapy relevant to the present benefit assessment.
Courtesy translation only, please refer to the German original.
Associated procedures
| Misoprostol (1) | Angusta® | Norgine GmbH | Labor induction | 76,500–90,000 | 100% additional benefit not proven |
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