Efmody
ﾘｧﾙﾘｨﾙﾘｯ: ﾘｧﾙﾘｧﾘｪﾘｭﾘｧﾘｯ ﾘｧﾙﾘ｣ﾙ畏ｱﾙ畏ｨﾙ
ﾘｧﾙﾙﾘｺﾘｩ: ﾘｧﾙﾘｨﾙﾘｺﾘｧﾘｱﾙ韓ｩ
ﾘｧﾙﾙﾘｵﾘｯﾘｱ: EMA (European Medicines Agency)
ﾙﾘｴﾘｱﾘｩ ﾘｧﾙﾙﾘｹﾙﾙ異ﾘｧﾘｪ
(PIL)
25-08-2023
ﾘｮﾘｵﾘｧﾘｦﾘｵ ﾘｧﾙﾙﾙﾘｪﾘｬ
(SPC)
25-08-2023
ﾘｪﾙぺｱﾙ韓ｱ ﾘｧﾙﾘｪﾙほ館館 ﾘｧﾙﾘｬﾙﾙﾙ畏ｱ
(PAR)
14-06-2021
ﾘｧﾙﾘｹﾙﾘｵﾘｱ ﾘｧﾙﾙﾘｴﾘｷ:
ﾑﾐｸﾐｴﾑﾐｾﾐｺﾐｾﾑﾑひｸﾐｷﾐｾﾐｽ
ﾙﾘｪﾘｧﾘｭ ﾙﾙ:
Diurnal Europe B.V.
ATC ﾘｱﾙﾘｲ:
H02AB09
INN (ﾘｧﾙﾘｧﾘｳﾙ ﾘｧﾙﾘｯﾙ異ﾙ):
hydrocortisone
ﾘｧﾙﾙﾘｬﾙﾙ畏ｹﾘｩ ﾘｧﾙﾘｹﾙﾘｧﾘｬﾙ韓ｩ:
ﾐ墟ｾﾑﾑひｸﾐｺﾐｾﾑﾑひｵﾑﾐｾﾐｸﾐｴﾐｸ ﾐｷﾐｰ ﾑﾐｸﾑﾑひｵﾐｼﾐｽﾐｰ ﾑσｿﾐｾﾑびﾐｵﾐｱﾐｰ
ﾘｧﾙﾙﾘｬﾘｧﾙ ﾘｧﾙﾘｹﾙﾘｧﾘｬﾙ:
Adrenal Hyperplasia, Congenital
ﾘｧﾙﾘｮﾘｵﾘｧﾘｦﾘｵ ﾘｧﾙﾘｹﾙﾘｧﾘｬﾙ韓ｩ:
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
ﾙﾙﾘｮﾘｵ ﾘｧﾙﾙﾙﾘｪﾘｬ:
Revision: 3
ﾘｧﾙﾙ畏ｶﾘｹ ﾘ･ﾘｰﾙ:
ﾑσｿﾑ諌ｻﾐｽﾐｾﾐｼﾐｾﾑ禍ｵﾐｽ
ﾘｪﾘｧﾘｱﾙ韓ｮ ﾘｧﾙﾘｪﾘｱﾘｮﾙ韓ｵ:
2021-05-27
ﾙﾘｴﾘｱﾘｩ ﾘｧﾙﾙﾘｹﾙﾙ異ﾘｧﾘｪ
36
ﾐ.
ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟
37
ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟: ﾐ侑斷､ﾐ榧ﾐ慴籍ｦﾐ侑ｯ ﾐ厘 ﾐ渙榧｢ﾐﾐ片岱侑｢ﾐ片嶢ｯ
EFMODY 5 MG ﾐ｢ﾐ漬ｪﾐﾐ頒 ﾐ墟籍渙｡ﾐ｣ﾐ嶢 ﾐ｡ ﾐ侑厘慴片斷片斷
ﾐ榧｡ﾐ漬榧岱榧孟頒籍漬籍斷
EFMODY 10 MG ﾐ｢ﾐ漬ｪﾐﾐ頒 ﾐ墟籍渙｡ﾐ｣ﾐ嶢 ﾐ｡ ﾐ侑厘慴片斷片斷
ﾐ榧｡ﾐ漬榧岱榧孟頒籍漬籍斷
EFMODY 20 MG ﾐ｢ﾐ漬ｪﾐﾐ頒 ﾐ墟籍渙｡ﾐ｣ﾐ嶢 ﾐ｡ ﾐ侑厘慴片斷片斷
ﾐ榧｡ﾐ漬榧岱榧孟頒籍漬籍斷
ﾑﾐｸﾐｴﾑﾐｾﾐｺﾐｾﾑﾑひｸﾐｷﾐｾﾐｽ (hydrocortisone)
ﾐ渙ﾐ榧ｧﾐ片｢ﾐ片｢ﾐ ﾐ漬斷侑慴籍｢ﾐ片嶢斷 ﾐｦﾐｯﾐ嶢籍｢ﾐ ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟,
ﾐ渙ﾐ片頒 ﾐ頒 ﾐ厘籍渙榧ｧﾐ斷片｢ﾐ ﾐ頒 ﾐ渙ﾐ侑片慴籍｢ﾐ ﾐ｢ﾐ榧漬
ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬,
ﾐ｢ﾐｪﾐ ﾐ墟籍｢ﾐ ﾐ｢ﾐｯ ﾐ｡ﾐｪﾐ頒ｪﾐﾐ孟 ﾐ漬籍孟斷 ﾐ厘 ﾐ漬籍｡
ﾐ侑斷､ﾐ榧ﾐ慴籍ｦﾐ侑ｯ.
-
ﾐ厘ｰﾐｿﾐｰﾐｷﾐｵﾑひｵ ﾑひｰﾐｷﾐｸ ﾐｻﾐｸﾑﾑひｾﾐｲﾐｺﾐｰ. ﾐ慴ｾﾐｶﾐｵ ﾐｴﾐｰ ﾑﾐｵ
ﾐｽﾐｰﾐｻﾐｾﾐｶﾐｸ ﾐｴﾐｰ ﾑ ﾐｿﾑﾐｾﾑﾐｵﾑひｵﾑひｵ ﾐｾﾑひｽﾐｾﾐｲﾐｾ.
-
ﾐ籍ｺﾐｾ ﾐｸﾐｼﾐｰﾑひｵ ﾐｽﾑ紹ｺﾐｰﾐｺﾐｲﾐｸ ﾐｴﾐｾﾐｿﾑ諌ｻﾐｽﾐｸﾑひｵﾐｻﾐｽﾐｸ
ﾐｲﾑ諌ｿﾑﾐｾﾑﾐｸ, ﾐｿﾐｾﾐｿﾐｸﾑひｰﾐｹﾑひｵ ﾐ漬ｰﾑ威ｸﾑ ﾐｻﾐｵﾐｺﾐｰﾑ ﾐｸﾐｻﾐｸ
ﾑﾐｰﾑﾐｼﾐｰﾑﾐｵﾐｲﾑ.
-
ﾐ｢ﾐｾﾐｲﾐｰ ﾐｻﾐｵﾐｺﾐｰﾑﾑﾑひｲﾐｾ ﾐｵ ﾐｿﾑﾐｵﾐｴﾐｿﾐｸﾑﾐｰﾐｽﾐｾ ﾐｻﾐｸﾑﾐｽﾐｾ ﾐｽﾐｰ
ﾐ漬ｰﾑ. ﾐ斷ｵ ﾐｳﾐｾ ﾐｿﾑﾐｵﾐｾﾑびﾑび諌ｿﾐｲﾐｰﾐｹﾑひｵ ﾐｽﾐｰ ﾐｴﾑﾑσｳﾐｸ
ﾑﾐｾﾑﾐｰ. ﾐ｢ﾐｾ ﾐｼﾐｾﾐｶﾐｵ
ﾐｴﾐｰ ﾐｸﾐｼ ﾐｽﾐｰﾐｲﾑﾐｵﾐｴﾐｸ, ﾐｽﾐｵﾐｷﾐｰﾐｲﾐｸﾑﾐｸﾐｼﾐｾ ﾑﾐｵ
ﾐｿﾑﾐｸﾐｷﾐｽﾐｰﾑﾐｸﾑひｵ ﾐｽﾐｰ ﾑび肖ﾐｽﾐｾﾑひｾ ﾐｷﾐｰﾐｱﾐｾﾐｻﾑ紹ｲﾐｰﾐｽﾐｵ ﾑﾐｰ
ﾑﾑ貫禍ｸﾑひｵ ﾐｺﾐｰﾑひｾ ﾐ漬ｰﾑ威ｸﾑひｵ.
-
ﾐ籍ｺﾐｾ ﾐｿﾐｾﾐｻﾑτﾐｸﾑひｵ ﾐｽﾑ紹ｺﾐｰﾐｺﾐｲﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ
ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ, ﾑσｲﾐｵﾐｴﾐｾﾐｼﾐｵﾑひｵ ﾐ漬ｰﾑ威ｸﾑ ﾐｻﾐｵﾐｺﾐｰﾑ ﾐｸﾐｻﾐｸ
ﾑﾐｰﾑﾐｼﾐｰﾑﾐｵﾐｲﾑ. ﾐ｢ﾐｾﾐｲﾐｰ
ﾐｲﾐｺﾐｻﾑ紗ﾐｲﾐｰ ﾐｸ ﾐｲﾑﾐｸﾑﾐｺﾐｸ ﾐｲﾑ諌ｷﾐｼﾐｾﾐｶﾐｽﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ
ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ, ﾐｽﾐｵﾐｾﾐｿﾐｸﾑﾐｰﾐｽﾐｸ ﾐｲ ﾑひｰﾐｷﾐｸ ﾐｻﾐｸﾑﾑひｾﾐｲﾐｺﾐｰ.
ﾐ漬ｸﾐｶﾑひｵ
ﾑひｾﾑﾐｺﾐｰ 4.
ﾐ墟籍墟漬 ﾐ｡ﾐｪﾐ頒ｪﾐﾐ孟 ﾐ｢ﾐ籍厘 ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟
1.
ﾐ墟ｰﾐｺﾐｲﾐｾ ﾐｿﾑﾐｵﾐｴﾑﾑひｰﾐｲﾐｻﾑ紹ｲﾐｰ Efmody ﾐｸ ﾐｷﾐｰ ﾐｺﾐｰﾐｺﾐｲﾐｾ ﾑﾐｵ
ﾐｸﾐｷﾐｿﾐｾﾐｻﾐｷﾐｲﾐｰ
2.
ﾐ墟ｰﾐｺﾐｲﾐｾ ﾑびﾑ紹ｱﾐｲﾐｰ ﾐｴﾐｰ ﾐｷﾐｽﾐｰﾐｵﾑひｵ, ﾐｿﾑﾐｵﾐｴﾐｸ ﾐｴﾐｰ
ﾐｿﾑﾐｸﾐｵﾐｼﾐｵﾑひｵ Efmody
3.
ﾐ墟ｰﾐｺ ﾐｴﾐｰ ﾐｿﾑﾐｸﾐｵﾐｼﾐｰﾑひｵ Efmody
4.
ﾐ柘諌ｷﾐｼﾐｾﾐｶﾐｽﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ
5.
ﾐ墟ｰﾐｺ ﾐｴﾐｰ ﾑﾑ貫ﾑﾐｰﾐｽﾑ紹ｲﾐｰﾑひｵ Efmody
6.
ﾐ｡ﾑ諌ｴﾑ貫ﾐｶﾐｰﾐｽﾐｸﾐｵ ﾐｽﾐｰ ﾐｾﾐｿﾐｰﾐｺﾐｾﾐｲﾐｺﾐｰﾑひｰ ﾐｸ
ﾐｴﾐｾﾐｿﾑ諌ｻﾐｽﾐｸﾑひｵﾐｻﾐｽﾐｰ ﾐｸﾐｽﾑﾐｾﾑﾐｼﾐｰﾑﾐｸﾑ
1.
ﾐ墟籍墟漬 ﾐ渙ﾐ片頒｡ﾐ｢ﾐ籍漬嶢ｯﾐ漬 EFMODY ﾐ ﾐ厘 ﾐ墟籍墟漬 ﾐ｡ﾐ
ﾘｧﾙぺｱﾘ｣ ﾘｧﾙﾙ畏ｫﾙ館ぺｩ ﾙﾘｧﾙﾙﾘｩ
ﾘｮﾘｵﾘｧﾘｦﾘｵ ﾘｧﾙﾙﾙﾘｪﾘｬ
1
ﾐ渙ﾐ侑嶢榧孟片斷侑 I
ﾐ墟ﾐ籍｢ﾐ墟 ﾐ･ﾐ籍ﾐ籍墟｢ﾐ片ﾐ侑｡ﾐ｢ﾐ侑墟 ﾐ斷 ﾐ渙ﾐ榧頒｣ﾐ墟｢ﾐ
2
1.
ﾐ侑慴 ﾐ斷 ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬片斷侑ｯ ﾐ渙ﾐ榧頒｣ﾐ墟｢
Efmody 5 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ
Efmody 10 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ
Efmody 20 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ
2.
ﾐ墟籍ｧﾐ片｡ﾐ｢ﾐ漬片 ﾐ ﾐ墟榧嶢侑ｧﾐ片｡ﾐ｢ﾐ漬片 ﾐ｡ﾐｪﾐ｡ﾐ｢ﾐ籍
Efmody 5 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ.
ﾐ柘ﾑ紹ｺﾐｰ ﾑひｲﾑ貫ﾐｴﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 5 mg
ﾑﾐｸﾐｴﾑﾐｾﾐｺﾐｾﾑﾑひｸﾐｷﾐｾﾐｽ (hydrocortisone).
Efmody 10 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ.
ﾐ柘ﾑ紹ｺﾐｰ ﾑひｲﾑ貫ﾐｴﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 10 mg
ﾑﾐｸﾐｴﾑﾐｾﾐｺﾐｾﾑﾑひｸﾐｷﾐｾﾐｽ
(hydrocortisone).
Efmody 20 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ.
ﾐ柘ﾑ紹ｺﾐｰ ﾑひｲﾑ貫ﾐｴﾐｰ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｰ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 20 mg
ﾑﾐｸﾐｴﾑﾐｾﾐｺﾐｾﾑﾑひｸﾐｷﾐｾﾐｽ
(hydrocortisone).
ﾐ厘ｰ ﾐｿﾑ諌ｻﾐｽﾐｸﾑ ﾑﾐｿﾐｸﾑﾑ諌ｺ ﾐｽﾐｰ ﾐｿﾐｾﾐｼﾐｾﾑ禍ｽﾐｸﾑひｵ
ﾐｲﾐｵﾑ禍ｵﾑﾑひｲﾐｰ ﾐｲﾐｸﾐｶﾑひｵ ﾑ. 6.1.
3.
ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬片斷 ﾐ､ﾐ榧ﾐ慴
ﾐ｢ﾐｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ
Efmody 5 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ
ﾐ墟ｰﾐｿﾑﾑσｻﾐｰ (ﾑ ﾐｴﾑ諌ｻﾐｶﾐｸﾐｽﾐｰ ﾐｾﾐｺﾐｾﾐｻﾐｾ 19 mm) ﾑ
ﾐｽﾐｵﾐｿﾑﾐｾﾐｷﾑﾐｰﾑﾐｽo ﾑﾐｸﾐｽﾑ糊ｾ ﾐｺﾐｰﾐｿﾐｰﾑﾐｵ ﾐｸ
ﾐｽﾐｵﾐｿﾑﾐｾﾐｷﾑﾐｰﾑﾐｽﾐｾ ﾐｱﾑ紹ｻﾐｾ ﾑび紹ｻﾐｾ ﾑ
ﾐｽﾐｰﾐｴﾐｿﾐｸﾑ 窶曚HC 5 mg窶, ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰﾑ禍ｰ ﾐｱﾐｵﾐｻﾐｸ ﾐｴﾐｾ
ﾐｿﾐｾﾑﾑひｸ ﾐｱﾐｵﾐｻﾐｸ ﾐｳﾑﾐｰﾐｽﾑσｻﾐｸ.
Efmody 10 mg ﾑひｲﾑ貫ﾐｴﾐｸ ﾐｺﾐｰﾐｿﾑﾑσｻﾐｸ ﾑ ﾐｸﾐｷﾐｼﾐｵﾐｽﾐｵﾐｽﾐｾ
ﾐｾﾑﾐｲﾐｾﾐｱﾐｾﾐｶﾐｴﾐｰﾐｲﾐｰﾐｽﾐｵ
ﾐ墟ｰﾐｿﾑﾑσｻﾐｰ (ﾑ ﾐｴﾑ諌ｻﾐｶﾐｸﾐｽﾐｰ ﾐｾﾐｺﾐｾﾐｻﾐｾ 19 mm) ﾑ
ﾐｽﾐｵﾐｿﾑﾐｾﾐｷﾑﾐｰﾑﾐｽﾐｾ ﾐｷﾐｵﾐｻﾐｵﾐｽﾐｾ ﾐｺﾐｰﾐｿﾐｰﾑﾐｵ ﾐｸ
ﾐｽﾐｵﾐｿﾑﾐｾﾐｷﾑﾐｰﾑﾐｽﾐｾ ﾐｱﾑ紹ｻﾐｾ ﾑび紹ｻﾐｾ ﾑ
ﾐｽﾐｰﾐｴﾐｿﾐｸﾑ 窶曚HC 10 mg窶, ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰﾑ禍ｰ ﾐｱﾐｵﾐｻﾐｸ ﾐｴﾐｾ
ﾐｿﾐｾﾑﾑひｸ ﾐｱﾐｵﾐｻﾐ
ﾘｧﾙぺｱﾘ｣ ﾘｧﾙﾙ畏ｫﾙ館ぺｩ ﾙﾘｧﾙﾙﾘｩ
